Shigella Sonnei Infection
Conditions
Brief summary
The purpose of this study is to evaluate the safety and the immunogenicity of two different doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards testing of the GMMA vaccine in the vaccine target population of children from developing countries where shigellosis is endemic.
Interventions
BIOLOGICALGVGH S. sonnei (1790GAHB) vaccine 25 μg
Two injections of the study vaccine were administered 28 days apart.
BIOLOGICALGVGH S. sonnei (1790GAHB) vaccine 100 μg
Two injections of the study vaccine were administered 28 days apart.
BIOLOGICALMenveo
One injection of Menveo was administered in subjects in the Control Group.
BIOLOGICALBoostrix
One injection of Boostrix was administered in subjects in the Control Group.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Individuals ≥18 years to ≤45 years of age on the day of informed consent who are resident in the study area and are not planning to leave during the study period. 2. Individuals who, after the nature of the study has been explained, have voluntarily given written consent according to local regulatory requirements, prior to study entry. 3. Individuals who can comply with study procedures including follow-up. 4. Individuals in good health as determined by the outcome of medical history, physical examination, hematology, renal function, and liver function tests, urine dipstick/urinalysis and the clinical judgment of the investigator. 5. Males Or Females of childbearing potential who are using an effective birth control method which they intend to use for the duration of the study Or Females without childbearing potential (i.e. irrespective of birth control method) Prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet any of the original inclusion criteria listed above, they should not receive additional vaccinations.
Exclusion criteria
1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study. 2. Individuals with any progressive or severe neurological disorder, seizure disorder or previous Guillain-Barré syndrome. 3. Individuals who, in the judgment of the investigator, may not be able to comply with all the required study procedures. 4. Individuals with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study. 5. Individuals with history of reactive arthritis. 6. Individuals with known HIV or hepatitis B virus infection or HIV related disease, history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system. Individuals under systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to screening. 7. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. 8. Individuals with a neutrophil count lower than 1.8 x 10\^9/L (applicable to the initial 18 subjects) or lower than 1.0 x 10\^9/L (applicable to the additional subjects if approved by DSMB) at screening 9. Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes, Type 2 diabetes mellitus, hypertension, cardiac, renal or hepatic disease and tuberculosis). 10. Individuals who have any malignancy or lymphoproliferative disorder. 11. Individuals with history of allergy to vaccines components or any other allergies deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial. 12. Individuals participating in any clinical trial with another investigational product within 28 days prior to the screening study visit or intent to participate in another clinical study at any time during the conduct of this study. 13. Individuals who received vaccines containing meningococcal A, C, W, Y or tetanus, diphtheria or pertussis antigens within 12 months before screening, or any other vaccines within 4 weeks prior to screening in this study or who are planning to receive any vaccine within the entire study duration. 14. Individuals who have received blood, blood products, and/or plasma derivatives including parenteral immunoglobulin preparations in the 12 weeks prior to the first dose of the study vaccine. 15. Individuals who are study personnel or immediate family members (parents, children, spouse and brothers/sisters) to the personnel conducting this study. 16. Individuals with body temperature \> 38.0°C within 3 days of intended study vaccination is a reason for delay of vaccination 17. Individuals with Body Mass Index (BMI)\> 30 kg/m\^2 18. Individuals with history of substance or alcohol abuse within the past 2 years. 19. Women who are pregnant or are breast-feeding, or are of childbearing age who have not used (for the two months preceding the 1st vaccination) and are not willing to use acceptable contraceptive measures, for the duration of the study. If subjects are women of childbearing potential, they must have a negative pregnancy test at screening visit and prior to enrollment (visit 1). For the purposes of this study acceptable methods of contraception are oral, injected or implantable contraceptives. 20. Individuals who have a previously laboratory confirmed case of disease caused by S. sonnei. 21. Any condition which, in the opinion of the investigator, may pose an increased and unreasonable safety risk to the subject if they participated in the study. 22. Individuals with a previous history of Benign Ethnic Neutropenia or drug related neutropenia. 23. Individuals who have or are likely to require concomitant treatment with neutropenic agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Reported Reactive Arthritis or Neutropenia (AESIs) | Throughout the whole study period (from Day 1 up to Day 57) | Reactive arthritis is defined as non-purulent joint inflammation that develops in response to an infection in another part of the body. Since the inflammation is triggered by a previous condition, it is termed reactive. Intestinal pathogens that have been associated with reactive arthritis include Campylobacter, Salmonella, Yersinia, Clostridium difficile, and Shigella. If reactive arthritis is caused by an auto immune response, there is at least a possibility that it could be initiated by vaccination of susceptible people with the 1790GAHB vaccine. |
| Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | At Day 8 (7 days after first vaccination) | The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase \[ALP\], Alanine Aminotransferase \[ALA\], Aspartate Aminotransferase \[AST\], Bilirubin \[BILI\], Blood Urea Nitrogen \[BUN\], Creatinine \[CREAT\], Gamma Glutamyl Transferase \[GGT\], Glucose \[GLUC\], Potassium \[K\], Lactate Dehydrogenase \[LDH\] and Sodium \[Na\]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | At Day 29 (28 days after the first vaccination) | The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase \[ALP\], Alanine Aminotransferase \[ALA\], Aspartate Aminotransferase \[AST\], Bilirubin \[BILI\], Blood Urea Nitrogen \[BUN\], Creatinine \[CREAT\], Gamma Glutamyl Transferase \[GGT\], Glucose \[GLUC\], Potassium \[K\], Lactate Dehydrogenase \[LDH\] and Sodium \[Na\]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | At Day 36 (7 days after the second vaccination) | The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase \[ALP\], Alanine Aminotransferase \[ALA\], Aspartate Aminotransferase \[AST\], Bilirubin \[BILI\], Blood Urea Nitrogen \[BUN\], Creatinine \[CREAT\], Gamma Glutamyl Transferase \[GGT\], Glucose \[GLUC\], Potassium \[K\], Lactate Dehydrogenase \[LDH\] and Sodium \[Na\]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | At Day 57 (28 days after the second vaccination) | The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase \[ALP\], Alanine Aminotransferase \[ALA\], Aspartate Aminotransferase \[AST\], Bilirubin \[BILI\], Blood Urea Nitrogen \[BUN\], Creatinine \[CREAT\], Gamma Glutamyl Transferase \[GGT\], Glucose \[GLUC\], Potassium \[K\], Lactate Dehydrogenase \[LDH\] and Sodium \[Na\]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | From 30 minutes up to 7 days following each vaccination | Assessed solicited local adverse reactions were injection site erythema, induration, pain. Assessed systemic adverse reactions were headache, arthralgia, chills, fatigue, malaise, myalgia and temperature (body temperature measured axillary). Any = occurrence of the symptom regardless of intensity grade. Any temperature = body temperature ≥ 38.0°C. Severe symptom = pain, headache, arthralgia, chills, fatigue, malaise and myalgia that prevented normal activity. Severe redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Severe temperature = body temperature \> 40.0 °C. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | During 28 days following each vaccination | An unsolicited AE is an AE that was not solicited using the Diary Card and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject. Note: \*disruptions= dose reduction, interruption or delay in study vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | Throughout the whole study period (from Day 1 up to Day 57) | An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; is life-threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); it does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions); congenital anomaly/or birth defect; an important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples | At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination) | The ratio was expressed as unadjusted geometric mean ratio (GMR) and presented with its 95% confidence interval (CI). |
| Number of Subjects With Seroresponse to Anti-LPS S. Sonnei IgG ELISA, by Baseline Titer | At Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination) | Seroresponse was defined as: if the baseline value was greater than 50 EU then an increase of at least 50% in the post-vaccination sample as compared to baseline (i.e., \[{post-vac minus baseline}/baseline\]100% ≥ 50%); if the baseline value was less or equal to 50 EU then an increase of at least 25 EU in the post-vaccination sample as compared to baseline (i.e., \[post-vac minus baseline\] ≥ 25 EU). Since all subjects in the study were from an endemic country, they had pre-vaccination titers equal to or above (≥) LLOQ (limit of detection). |
| Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL | At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination) | The analysis cut-off value (121 U/mL) was expressed in units per milliliter (U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA). |
| Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer | At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination) | Anti-LPS S.Sonnei IgG ELISA concentrations were tabulated as unadjusted geometric mean concentrations (GMCs) and expressed as ELISA units (EU) per milliliter (mL), presented with their 95% confidence intervals (CIs). Since all subjects in the study were from an endemic country, they had pre-vaccination titers equal to or above (≥) LLOQ (limit of detection). |
Countries
Kenya
Participant flow
Recruitment details
Out of the 74 enrolled subjects, 2 subjects were allocated numbers but were not administered the study vaccine, hence they did not start the study.
Participants by arm
| Arm | Count |
|---|---|
| 1790GAHB 25 μg Group Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei. | 22 |
| 1790GAHB 100 μg Group Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei. | 26 |
| Control Group Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine. | 24 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative reason | 1 | 0 | 0 |
| Overall Study | Adverse Event | 0 | 3 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | 1790GAHB 25 μg Group | 1790GAHB 100 μg Group | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 24.6 Years STANDARD_DEVIATION 5.81 | 26.9 Years STANDARD_DEVIATION 8.44 | 28.3 Years STANDARD_DEVIATION 8.23 | 26.7 Years STANDARD_DEVIATION 7.7 |
| Race/Ethnicity, Customized Black/African American | 21 Participants | 26 Participants | 24 Participants | 71 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 20 Participants | 23 Participants | 21 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 26 | 0 / 24 |
| other Total, other adverse events | 22 / 22 | 26 / 26 | 24 / 24 |
| serious Total, serious adverse events | 2 / 22 | 3 / 26 | 1 / 24 |
Outcome results
Primary
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE is an AE that was not solicited using the Diary Card and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject. Note: \*disruptions= dose reduction, interruption or delay in study vaccination.
Time frame: During 28 days following each vaccination
Population: This analysis was performed on the Unsolicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom unsolicited adverse event data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1790GAHB 25 μg Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Possibly or Probably related AE | 13 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | AE leading to hospitalization | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | AE leading to disruptions* | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Any AE | 19 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Deaths | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | AE of special interest (Neutropenia) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | AE leading to study vaccine withdrawal | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | AE leading to disruptions* | 3 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Any AE | 24 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Possibly or Probably related AE | 16 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | AE leading to study vaccine withdrawal | 3 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | AE leading to hospitalization | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | AE of special interest (Neutropenia) | 3 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Deaths | 0 Participants |
| Control Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | AE leading to hospitalization | 0 Participants |
| Control Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Possibly or Probably related AE | 12 Participants |
| Control Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Deaths | 0 Participants |
| Control Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | AE of special interest (Neutropenia) | 1 Participants |
| Control Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | AE leading to disruptions* | 0 Participants |
| Control Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | AE leading to study vaccine withdrawal | 1 Participants |
| Control Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Any AE | 19 Participants |
Primary
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase \[ALP\], Alanine Aminotransferase \[ALA\], Aspartate Aminotransferase \[AST\], Bilirubin \[BILI\], Blood Urea Nitrogen \[BUN\], Creatinine \[CREAT\], Gamma Glutamyl Transferase \[GGT\], Glucose \[GLUC\], Potassium \[K\], Lactate Dehydrogenase \[LDH\] and Sodium \[Na\]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 29 (28 days after the first vaccination)
Population: This analysis was performed on the Overall Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited and/or unsolicited adverse event data were available. Less subjects were available with each subsequent visit, hence the number of subjects analysed is lower than in the previous timepoints.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Above (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Within (baseline) - within (Day 29) | 19 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Within (baseline) - within (Day 29) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Within (baseline) - within (Day 29) | 19 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Above (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Within (baseline) - below (Day 29) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Within (baseline) - within (Day 29) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Below (baseline) - below (Day 29) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Below (baseline) - within (Day 29) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Below (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Within (baseline) - within (Day 29) | 15 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Within (baseline) - within (Day 29) | 9 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Within (baseline) - within (Day 29) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Above (baseline) - within (Day 29) | 4 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Above (baseline) - above (Day 29) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Below (baseline) - below (Day 29) | 3 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Within (baseline) - below (Day 29) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Within (baseline) - within (Day 29) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Below (baseline) - within (Day 29) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Above (baseline) - above (Day 29) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Within (baseline) - above (Day 29) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Within (baseline) - within (Day 29) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Within (baseline) - above (Day 29) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Above (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Above (baseline) - above (Day 29) | 6 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Within (baseline) - below (Day 29) | 4 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Within (baseline) - within (Day 29) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Within (baseline) - within (Day 29) | 19 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Within (baseline) - within (Day 29) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Within (baseline) - below (Day 29) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Below (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Within (baseline) - within (Day 29) | 18 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Within (baseline) - within (Day 29) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Within (baseline) - below (Day 29) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Within (baseline) - within (Day 29) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Within (baseline) - within (Day 29) | 19 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Above (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Above (baseline) - above (Day 29) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Within (baseline) - within (Day 29) | 18 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Above (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Within (baseline) - above (Day 29) | 3 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Within (baseline) - within (Day 29) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Within (baseline) - within (Day 29) | 22 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Within (baseline) - below (Day 29) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Above (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Within (baseline) - within (Day 29) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Within (baseline) - within (Day 29) | 22 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Within (baseline) - within (Day 29) | 24 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Within (baseline) - below (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Within (baseline) - within (Day 29) | 23 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Within (baseline) - above (Day 29) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Within (baseline) - below (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Within (baseline) - below (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Within (baseline) - within (Day 29) | 15 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Above (baseline) - above (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Above (baseline) - within (Day 29) | 4 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Within (baseline) - above (Day 29) | 6 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Below (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Within (baseline) - within (Day 29) | 22 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Within (baseline) - below (Day 29) | 6 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Above (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Below (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Within (baseline) - within (Day 29) | 19 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Within (baseline) - above (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Within (baseline) - within (Day 29) | 24 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Within (baseline) - above (Day 29) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Below (baseline) - below (Day 29) | 4 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Within (baseline) - below (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Within (baseline) - below (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Within (baseline) - below (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Below (baseline) - within (Day 29) | 5 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Within (baseline) - within (Day 29) | 15 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Within (baseline) - above (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Below (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Within (baseline) - within (Day 29) | 24 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Within (baseline) - within (Day 29) | 25 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Within (baseline) - above (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Below (baseline) - below (Day 29) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Below (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Within (baseline) - within (Day 29) | 22 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Within (baseline) - above (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Within (baseline) - within (Day 29) | 26 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Within (baseline) - within (Day 29) | 24 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Above (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Within (baseline) - below (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Within (baseline) - within (Day 29) | 21 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Above (baseline) - within (Day 29) | 4 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Within (baseline) - within (Day 29) | 8 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Above (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Above (baseline) - within (Day 29) | 4 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Within (baseline) - within (Day 29) | 24 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Within (baseline) - above (Day 29) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Above (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Above (baseline) - above (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Within (baseline) - above (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Above (baseline) - above (Day 29) | 12 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Within (baseline) - within (Day 29) | 23 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Above (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Within (baseline) - below (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Within (baseline) - below (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Below (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Within (baseline) - within (Day 29) | 24 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Within (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Above (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Within (baseline) - within (Day 29) | 22 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Within (baseline) - below (Day 29) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Within (baseline) - above (Day 29) | 3 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Above (baseline) - above (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Within (baseline) - within (Day 29) | 21 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Above (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Below (baseline) - above (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Within (baseline) - above (Day 29) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Above (baseline) - above (Day 29) | 3 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Below (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Within (baseline) - within (Day 29) | 23 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Within (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Above (baseline) - below (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Below (baseline) - within (Day 29) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Above (baseline) - within (Day 29) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Within (baseline) - within (Day 29) | 26 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Above (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Below (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Below (baseline) - within (Day 29) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Within (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Within (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Above (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Within (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Below (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Above (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Within (baseline) - within (Day 29) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Above (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Above (baseline) - within (Day 29) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Within (baseline) - above (Day 29) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Below (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Within (baseline) - within (Day 29) | 4 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Above (baseline) - within (Day 29) | 7 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Within (baseline) - above (Day 29) | 3 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Above (baseline) - above (Day 29) | 8 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Below (baseline) - below (Day 29) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Within (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Within (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Within (baseline) - below (Day 29) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Below (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Within (baseline) - within (Day 29) | 19 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Above (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Within (baseline) - above (Day 29) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALP | Above (baseline) - above (Day 29) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Within (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Below (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Within (baseline) - within (Day 29) | 22 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Above (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Within (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | AST | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Within (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Below (baseline) - within (Day 29) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Within (baseline) - within (Day 29) | 20 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Above (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Within (baseline) - above (Day 29) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Eosinophils | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Within (baseline) - within (Day 29) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Above (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Erythrocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Within (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Below (baseline) - within (Day 29) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Within (baseline) - within (Day 29) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Above (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Within (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hematocrit | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Within (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Below (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Within (baseline) - within (Day 29) | 22 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Above (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Hemoglobin | Within (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Within (baseline) - within (Day 29) | 22 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Above (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Within (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Leukocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Within (baseline) - within (Day 29) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Within (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BILI | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Within (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Below (baseline) - within (Day 29) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Within (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | BUN | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Within (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Below (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Within (baseline) - within (Day 29) | 19 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Above (baseline) - within (Day 29) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Within (baseline) - above (Day 29) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | CREA | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Within (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Below (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Within (baseline) - within (Day 29) | 18 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GGT | Above (baseline) - above (Day 29) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Within (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Below (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Within (baseline) - within (Day 29) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Above (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Within (baseline) - above (Day 29) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | GLUC | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Within (baseline) - below (Day 29) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Below (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Within (baseline) - within (Day 29) | 19 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Above (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Within (baseline) - above (Day 29) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | LDH | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Within (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Below (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Within (baseline) - within (Day 29) | 16 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Above (baseline) - within (Day 29) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Within (baseline) - above (Day 29) | 4 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | K | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Within (baseline) - below (Day 29) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Below (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Within (baseline) - within (Day 29) | 20 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Above (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Within (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Na | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Within (baseline) - within (Day 29) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Above (baseline) - within (Day 29) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Lymphocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Below (baseline) - below (Day 29) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Within (baseline) - below (Day 29) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Below (baseline) - within (Day 29) | 6 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Within (baseline) - within (Day 29) | 14 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Monocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Within (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Below (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Within (baseline) - within (Day 29) | 22 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Above (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Within (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Neutrophils | Above (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Below (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Within (baseline) - below (Day 29) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Within (baseline) - within (Day 29) | 20 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Above (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Below (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Platelets | Within (baseline) - above (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Within (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Above (baseline) - below (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Below (baseline) - within (Day 29) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | ALA | Within (baseline) - within (Day 29) | 22 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | Basophils | Within (baseline) - below (Day 29) | 0 Participants |
Primary
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase \[ALP\], Alanine Aminotransferase \[ALA\], Aspartate Aminotransferase \[AST\], Bilirubin \[BILI\], Blood Urea Nitrogen \[BUN\], Creatinine \[CREAT\], Gamma Glutamyl Transferase \[GGT\], Glucose \[GLUC\], Potassium \[K\], Lactate Dehydrogenase \[LDH\] and Sodium \[Na\]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 36 (7 days after the second vaccination)
Population: This analysis was performed on the Overall Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited and/or unsolicited adverse event data were available. Less subjects were available with each subsequent visit, hence the number of subjects analysed is lower than in the previous timepoints.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Within (baseline) - within (Day 36) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Above (baseline) - within (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Within (baseline) - within (Day 36) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Within (baseline) - above (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Within (baseline) - within (Day 36) | 22 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Above (baseline) - within (Day 36) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Above (baseline) - above (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Within (baseline) - within (Day 36) | 8 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Within (baseline) - within (Day 36) | 9 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Within (baseline) - within (Day 36) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Within (baseline) - within (Day 36) | 19 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Within (baseline) - above (Day 36) | 11 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Within (baseline) - below (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Within (baseline) - above (Day 36) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Above (baseline) - above (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Within (baseline) - within (Day 36) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Within (baseline) - within (Day 36) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Within (baseline) - within (Day 36) | 22 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Above (baseline) - above (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Below (baseline) - Within (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Above (baseline) - within (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Above (baseline) - above (Day 36) | 8 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Within (baseline) - above (Day 36) | 3 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Within (baseline) - below (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Above (baseline) - within (Day 36) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Within (baseline) - within (Day 36) | 15 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Within (baseline) - above (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Within (baseline) - within (Day 36) | 22 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Below (baseline) - Within (Day 36) | 4 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Within (baseline) - below (Day 36) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Within (baseline) - below (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Below (baseline) - below (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Within (baseline) - above (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Within (baseline) - within (Day 36) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Above (baseline) - within (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Within (baseline) - within (Day 36) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Within (baseline) - above (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Within (baseline) - within (Day 36) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Within (baseline) - below (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Within (baseline) - below (Day 36) | 3 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Above (baseline) - above (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Below (baseline) - Within (Day 36) | 3 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Within (baseline) - within (Day 36) | 16 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Above (baseline) - within (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Within (baseline) - within (Day 36) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Within (baseline) - within (Day 36) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Within (baseline) - below (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Within (baseline) - below (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Within (baseline) - below (Day 36) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Below (baseline) - Within (Day 36) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Within (baseline) - within (Day 36) | 19 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Within (baseline) - within (Day 36) | 22 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Within (baseline) - within (Day 36) | 22 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Within (baseline) - within (Day 36) | 7 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Within (baseline) - above (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Within (baseline) - within (Day 36) | 13 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Within (baseline) - above (Day 36) | 7 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Within (baseline) - within (Day 36) | 24 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Within (baseline) - within (Day 36) | 22 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Within (baseline) - above (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Above (baseline) - above (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Within (baseline) - below (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Within (baseline) - within (Day 36) | 21 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Above (baseline) - within (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Above (baseline) - above (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Within (baseline) - below (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Below (baseline) - Within (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Within (baseline) - within (Day 36) | 21 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Above (baseline) - within (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Below (baseline) - below (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Within (baseline) - within (Day 36) | 23 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Within (baseline) - below (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Within (baseline) - within (Day 36) | 17 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Above (baseline) - within (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Within (baseline) - above (Day 36) | 5 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Within (baseline) - within (Day 36) | 19 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Above (baseline) - within (Day 36) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Within (baseline) - above (Day 36) | 3 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Within (baseline) - within (Day 36) | 24 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Within (baseline) - within (Day 36) | 23 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Above (baseline) - within (Day 36) | 6 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Within (baseline) - above (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Above (baseline) - above (Day 36) | 10 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Within (baseline) - below (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Below (baseline) - Within (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Within (baseline) - within (Day 36) | 22 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Within (baseline) - within (Day 36) | 22 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Above (baseline) - within (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Above (baseline) - above (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Within (baseline) - within (Day 36) | 20 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Above (baseline) - within (Day 36) | 4 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Within (baseline) - within (Day 36) | 23 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Above (baseline) - within (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Within (baseline) - within (Day 36) | 22 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Above (baseline) - within (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Within (baseline) - above (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Within (baseline) - within (Day 36) | 23 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Within (baseline) - above (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Below (baseline) - below (Day 36) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Below (baseline) - Within (Day 36) | 6 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Within (baseline) - within (Day 36) | 15 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Within (baseline) - above (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Within (baseline) - within (Day 36) | 24 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Within (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Above (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Below (baseline) - below (Day 36) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Above (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Within (baseline) - within (Day 36) | 22 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Below (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Within (baseline) - below (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Below (baseline) - Within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Above (baseline) - within (Day 36) | 4 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Below (baseline) - above (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Within (baseline) - below (Day 36) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Below (baseline) - Within (Day 36) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Within (baseline) - within (Day 36) | 20 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Above (baseline) - within (Day 36) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Within (baseline) - above (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Above (baseline) - within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Above (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Within (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Above (baseline) - within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Within (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Above (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Within (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Below (baseline) - Within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Below (baseline) - Within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Above (baseline) - within (Day 36) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Within (baseline) - within (Day 36) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Above (baseline) - within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Within (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Above (baseline) - within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Within (baseline) - within (Day 36) | 20 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Below (baseline) - Within (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Within (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Within (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Above (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hemoglobin | Above (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Within (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Within (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BUN | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Within (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Above (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Within (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Below (baseline) - Within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Above (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Within (baseline) - within (Day 36) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Above (baseline) - within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Within (baseline) - below (Day 36) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Above (baseline) - within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Within (baseline) - within (Day 36) | 20 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Above (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Below (baseline) - Within (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Above (baseline) - within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Within (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Leukocytes | Above (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Within (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Within (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | BILI | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Within (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Within (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Above (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Below (baseline) - Within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Within (baseline) - above (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Above (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Below (baseline) - Within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Within (baseline) - above (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Within (baseline) - within (Day 36) | 19 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Above (baseline) - within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Within (baseline) - within (Day 36) | 19 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Above (baseline) - within (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Within (baseline) - within (Day 36) | 20 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Below (baseline) - Within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Within (baseline) - above (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Above (baseline) - within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Lymphocytes | Above (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Within (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Within (baseline) - within (Day 36) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Below (baseline) - below (Day 36) | 3 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | AST | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Within (baseline) - below (Day 36) | 3 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Above (baseline) - above (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Platelet | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Within (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Above (baseline) - within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Below (baseline) - Within (Day 36) | 4 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Below (baseline) - Within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Within (baseline) - within (Day 36) | 19 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Within (baseline) - within (Day 36) | 5 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Within (baseline) - below (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Above (baseline) - within (Day 36) | 5 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | LDH | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Within (baseline) - within (Day 36) | 11 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Above (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Above (baseline) - within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Within (baseline) - above (Day 36) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Within (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Within (baseline) - within (Day 36) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Above (baseline) - above (Day 36) | 9 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Above (baseline) - within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Above (baseline) - within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Within (baseline) - within (Day 36) | 19 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Within (baseline) - below (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Within (baseline) - within (Day 36) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Above (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Below (baseline) - Within (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Below (baseline) - Within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Within (baseline) - within (Day 36) | 18 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Below (baseline) - Within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Above (baseline) - within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Within (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Na | Below (baseline) - Within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GLUC | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Within (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Within (baseline) - above (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Above (baseline) - above (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Eosinophils | Above (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Within (baseline) - above (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Within (baseline) - below (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Monocytes | Above (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Within (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Above (baseline) - within (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Within (baseline) - below (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Within (baseline) - within (Day 36) | 18 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Below (baseline) - Within (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Below (baseline) - Within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Within (baseline) - within (Day 36) | 20 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALP | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Above (baseline) - within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Below (baseline) - Within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Within (baseline) - above (Day 36) | 3 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Within (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Within (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Within (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Above (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Erythrocytes | Above (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Basophils | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Above (baseline) - within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Within (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Within (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Within (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | GGT | Below (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Below (baseline) - Within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Above (baseline) - below (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Above (baseline) - above (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Below (baseline) - Within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Below (baseline) - Within (Day 36) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Within (baseline) - above (Day 36) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Within (baseline) - within (Day 36) | 20 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Neutrophils | Within (baseline) - within (Day 36) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Above (baseline) - within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Within (baseline) - within (Day 36) | 18 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | ALA | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Below (baseline) - above (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | CREA | Below (baseline) - Within (Day 36) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | K | Within (baseline) - within (Day 36) | 15 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | Hematocrit | Within (baseline) - above (Day 36) | 0 Participants |
Primary
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase \[ALP\], Alanine Aminotransferase \[ALA\], Aspartate Aminotransferase \[AST\], Bilirubin \[BILI\], Blood Urea Nitrogen \[BUN\], Creatinine \[CREAT\], Gamma Glutamyl Transferase \[GGT\], Glucose \[GLUC\], Potassium \[K\], Lactate Dehydrogenase \[LDH\] and Sodium \[Na\]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 57 (28 days after the second vaccination)
Population: This analysis was performed on the Overall Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited and/or unsolicited adverse event data were available. Less subjects were available with each subsequent visit, hence the number of subjects analysed is lower than in the previous timepoints.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Within (baseline) - within (Day 57) | 8 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Above (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Within (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Within (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Within (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Within (baseline) - above (Day 57) | 3 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Within (baseline) - within (Day 57) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Within (baseline) - within (Day 57) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Within (baseline) - within (Day 57) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Above (baseline) - within (Day 57) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Within (baseline) - within (Day 57) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Below (baseline) - below (Day 57) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Within (baseline) - below (Day 57) | 3 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Below (baseline) - within (Day 57) | 4 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Within (baseline) - within (Day 57) | 13 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Within (baseline) - within (Day 57) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Within (baseline) - below (Day 57) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Within (baseline) - within (Day 57) | 18 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Above (baseline) - within (Day 57) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Within (baseline) - within (Day 57) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Within (baseline) - within (Day 57) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Within (baseline) - within (Day 57) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Within (baseline) - below (Day 57) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Below (baseline) - within (Day 57) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Within (baseline) - within (Day 57) | 17 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Below (baseline) - within (Day 57) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Within (baseline) - within (Day 57) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Within (baseline) - within (Day 57) | 18 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Within (baseline) - above (Day 57) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Above (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Within (baseline) - within (Day 57) | 19 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Above (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Within (baseline) - within (Day 57) | 18 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Within (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Within (baseline) - within (Day 57) | 15 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Above (baseline) - within (Day 57) | 3 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Within (baseline) - above (Day 57) | 3 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Within (baseline) - below (Day 57) | 4 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Within (baseline) - within (Day 57) | 17 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Above (baseline) - within (Day 57) | 5 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Within (baseline) - above (Day 57) | 4 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Above (baseline) - above (Day 57) | 4 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Below (baseline) - within (Day 57) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Within (baseline) - within (Day 57) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Within (baseline) - within (Day 57) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Above (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Within (baseline) - below (Day 57) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Within (baseline) - within (Day 57) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Above (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Within (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Within (baseline) - within (Day 57) | 7 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Below (baseline) - within (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Above (baseline) - within (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Within (baseline) - within (Day 57) | 20 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Within (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Above (baseline) - within (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Above (baseline) - within (Day 57) | 7 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Within (baseline) - above (Day 57) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Within (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Within (baseline) - within (Day 57) | 19 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Above (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Above (baseline) - within (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Within (baseline) - within (Day 57) | 21 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Above (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Within (baseline) - within (Day 57) | 20 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Within (baseline) - within (Day 57) | 22 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Below (baseline) - below (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Below (baseline) - within (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Within (baseline) - within (Day 57) | 23 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Within (baseline) - below (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Within (baseline) - within (Day 57) | 20 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Above (baseline) - within (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Within (baseline) - within (Day 57) | 21 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Within (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Within (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Within (baseline) - within (Day 57) | 12 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Within (baseline) - above (Day 57) | 7 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Within (baseline) - below (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Above (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Above (baseline) - above (Day 57) | 8 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Within (baseline) - below (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Within (baseline) - within (Day 57) | 22 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Within (baseline) - below (Day 57) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Above (baseline) - within (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Below (baseline) - within (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Below (baseline) - below (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Within (baseline) - within (Day 57) | 22 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Above (baseline) - within (Day 57) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Within (baseline) - above (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Within (baseline) - within (Day 57) | 22 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Within (baseline) - within (Day 57) | 22 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Above (baseline) - within (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Within (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Above (baseline) - within (Day 57) | 3 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Within (baseline) - within (Day 57) | 21 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Below (baseline) - within (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Within (baseline) - above (Day 57) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Below (baseline) - below (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Below (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Within (baseline) - within (Day 57) | 19 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Within (baseline) - below (Day 57) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Within (baseline) - within (Day 57) | 22 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Below (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Within (baseline) - within (Day 57) | 19 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Below (baseline) - within (Day 57) | 6 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Within (baseline) - within (Day 57) | 20 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Within (baseline) - within (Day 57) | 15 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Above (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Above (baseline) - within (Day 57) | 3 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Above (baseline) - within (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Within (baseline) - above (Day 57) | 3 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Within (baseline) - below (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Below (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Within (baseline) - within (Day 57) | 22 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Above (baseline) - above (Day 57) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Within (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Below (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Within (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Within (baseline) - above (Day 57) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Below (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Within (baseline) - within (Day 57) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Above (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Within (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Within (baseline) - below (Day 57) | 6 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Within (baseline) - below (Day 57) | 4 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Below (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Below (baseline) - within (Day 57) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Within (baseline) - within (Day 57) | 15 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Above (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Below (baseline) - within (Day 57) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Below (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Within (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Below (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Within (baseline) - within (Day 57) | 20 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Within (baseline) - within (Day 57) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Above (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Above (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Within (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Within (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Above (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Below (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Within (baseline) - within (Day 57) | 20 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Above (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Within (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Within (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Above (baseline) - above (Day 57) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Within (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Below (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Within (baseline) - within (Day 57) | 6 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Within (baseline) - within (Day 57) | 20 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Within (baseline) - within (Day 57) | 20 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Above (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Within (baseline) - above (Day 57) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Above (baseline) - within (Day 57) | 8 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Within (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Below (baseline) - within (Day 57) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Within (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Above (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Within (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Within (baseline) - above (Day 57) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Within (baseline) - below (Day 57) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Above (baseline) - above (Day 57) | 6 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Below (baseline) - within (Day 57) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Above (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Within (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Within (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Within (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Below (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Within (baseline) - within (Day 57) | 19 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Above (baseline) - within (Day 57) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Below (baseline) - within (Day 57) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Within (baseline) - above (Day 57) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Basophils | Below (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Within (baseline) - within (Day 57) | 18 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Above (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Above (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Within (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Within (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Neutrophils | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Platelets | Within (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALT | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Within (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | ALP | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | AST | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BILI | Within (baseline) - within (Day 57) | 20 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Above (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | BUN | Within (baseline) - within (Day 57) | 19 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | CREAT | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Within (baseline) - above (Day 57) | 3 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Within (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Within (baseline) - within (Day 57) | 16 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Above (baseline) - within (Day 57) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GGT | Above (baseline) - above (Day 57) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Within (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Below (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Within (baseline) - within (Day 57) | 19 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Within (baseline) - above (Day 57) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Above (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Below (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Within (baseline) - within (Day 57) | 16 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Above (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Within (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Within (baseline) - within (Day 57) | 17 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Na | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | GLUC | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Within (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Below (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Within (baseline) - within (Day 57) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Within (baseline) - below (Day 57) | 4 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Above (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Within (baseline) - above (Day 57) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Within (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hemoglobin | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Within (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Eosinophils | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Below (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Within (baseline) - within (Day 57) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Within (baseline) - above (Day 57) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | LDH | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Within (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Leukocytes | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Within (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Within (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Below (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Below (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Within (baseline) - within (Day 57) | 20 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Above (baseline) - within (Day 57) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Within (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Lymphocytes | Above (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Below (baseline) - below (Day 57) | 4 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Below (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Within (baseline) - below (Day 57) | 6 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Above (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Within (baseline) - within (Day 57) | 17 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Below (baseline) - within (Day 57) | 3 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Erythrocytes | Within (baseline) - below (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Within (baseline) - within (Day 57) | 8 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Above (baseline) - within (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | K | Above (baseline) - within (Day 57) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Monocytes | Below (baseline) - above (Day 57) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | Hematocrit | Above (baseline) - below (Day 57) | 0 Participants |
Primary
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase \[ALP\], Alanine Aminotransferase \[ALA\], Aspartate Aminotransferase \[AST\], Bilirubin \[BILI\], Blood Urea Nitrogen \[BUN\], Creatinine \[CREAT\], Gamma Glutamyl Transferase \[GGT\], Glucose \[GLUC\], Potassium \[K\], Lactate Dehydrogenase \[LDH\] and Sodium \[Na\]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 8 (7 days after first vaccination)
Population: This analysis was performed on the Overall Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited and/or unsolicited adverse event data were available. Less subjects were available with each subsequent visit, hence the number of subjects analysed is lower than in the previous timepoints.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Within (baseline) - below (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Within (baseline) - below (Day 8) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Within (baseline) - within (Day 8) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Within (baseline) - within (Day 8) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Above (baseline) - within (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Within (baseline) - within (Day 8) | 15 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Within (baseline) - within (Day 8) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Within (baseline) - below (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Within (baseline) - within (Day 8) | 22 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Within (baseline) - within (Day 8) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Within (baseline) - within (Day 8) | 22 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Within (baseline) - within (Day 8) | 22 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Above (baseline) - within (Day 8) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Within (baseline) - above (Day 8) | 4 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Above (baseline) - above (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Above (baseline) - above (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Within (baseline) - below (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Within (baseline) - within (Day 8) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Within (baseline) - within (Day 8) | 22 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Above (baseline) - above (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Above (baseline) - within (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Below (baseline) - below (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Within (baseline) - within (Day 8) | 19 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Within (baseline) - above (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Within (baseline) - within (Day 8) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Below (baseline) - within (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Within (baseline) - below (Day 8) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Above (baseline) - within (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Within (baseline) - within (Day 8) | 17 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Within (baseline) - below (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Within (baseline) - within (Day 8) | 22 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Within (baseline) - within (Day 8) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Within (baseline) - below (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Above (baseline) - within (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Within (baseline) - within (Day 8) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Within (baseline) - within (Day 8) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Within (baseline) - within (Day 8) | 15 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Within (baseline) - within (Day 8) | 9 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Below (baseline) - within (Day 8) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Below (baseline) - within (Day 8) | 3 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Above (baseline) - within (Day 8) | 3 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Within (baseline) - below (Day 8) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Within (baseline) - above (Day 8) | 3 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Below (baseline) - below (Day 8) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Above (baseline) - above (Day 8) | 7 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Within (baseline) - below (Day 8) | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Within (baseline) - below (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Above (baseline) - within (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Below (baseline) - within (Day 8) | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Within (baseline) - within (Day 8) | 19 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Within (baseline) - within (Day 8) | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Within (baseline) - within (Day 8) | 25 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Within (baseline) - within (Day 8) | 22 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Below (baseline) - within (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Within (baseline) - within (Day 8) | 23 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Above (baseline) - above (Day 8) | 3 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Above (baseline) - within (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Within (baseline) - above (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Within (baseline) - below (Day 8) | 7 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Within (baseline) - within (Day 8) | 18 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Within (baseline) - below (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Within (baseline) - within (Day 8) | 23 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Within (baseline) - above (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Above (baseline) - above (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Within (baseline) - within (Day 8) | 26 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Within (baseline) - within (Day 8) | 9 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Above (baseline) - within (Day 8) | 5 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Within (baseline) - above (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Above (baseline) - above (Day 8) | 11 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Within (baseline) - below (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Below (baseline) - within (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Within (baseline) - within (Day 8) | 24 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Within (baseline) - within (Day 8) | 26 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Within (baseline) - within (Day 8) | 24 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Within (baseline) - within (Day 8) | 16 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Above (baseline) - within (Day 8) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Within (baseline) - above (Day 8) | 6 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Above (baseline) - above (Day 8) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Below (baseline) - below (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Within (baseline) - below (Day 8) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Within (baseline) - within (Day 8) | 23 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Above (baseline) - within (Day 8) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Within (baseline) - below (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Within (baseline) - within (Day 8) | 21 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Above (baseline) - within (Day 8) | 3 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Above (baseline) - above (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Within (baseline) - below (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Within (baseline) - within (Day 8) | 24 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Above (baseline) - within (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Above (baseline) - within (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Within (baseline) - within (Day 8) | 26 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Below (baseline) - below (Day 8) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Within (baseline) - below (Day 8) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Below (baseline) - within (Day 8) | 7 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Within (baseline) - within (Day 8) | 15 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Within (baseline) - within (Day 8) | 26 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Below (baseline) - below (Day 8) | 3 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Within (baseline) - within (Day 8) | 21 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Within (baseline) - above (Day 8) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Within (baseline) - within (Day 8) | 26 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Within (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Within (baseline) - within (Day 8) | 25 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Above (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Above (baseline) - above (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Within (baseline) - below (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Below (baseline) - within (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Within (baseline) - within (Day 8) | 23 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Above (baseline) - within (Day 8) | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Below (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Within (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Above (baseline) - above (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Below (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Within (baseline) - below (Day 8) | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Above (baseline) - below (Day 8) | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Below (baseline) - within (Day 8) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Below (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Within (baseline) - within (Day 8) | 22 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Within (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Above (baseline) - within (Day 8) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Within (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Above (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Below (baseline) - below (Day 8) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Within (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Within (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Above (baseline) - above (Day 8) | 10 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Within (baseline) - above (Day 8) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Below (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Below (baseline) - below (Day 8) | 4 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Within (baseline) - below (Day 8) | 3 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Above (baseline) - within (Day 8) | 6 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Above (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Within (baseline) - within (Day 8) | 5 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Below (baseline) - within (Day 8) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Below (baseline) - within (Day 8) | 3 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Below (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Below (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Within (baseline) - within (Day 8) | 13 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Within (baseline) - within (Day 8) | 20 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Within (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Within (baseline) - below (Day 8) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Within (baseline) - within (Day 8) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Within (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Basophils | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Above (baseline) - above (Day 8) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Monocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Above (baseline) - within (Day 8) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Within (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Within (baseline) - within (Day 8) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Within (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Below (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Below (baseline) - within (Day 8) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Below (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Within (baseline) - within (Day 8) | 22 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Within (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Above (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Below (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Within (baseline) - above (Day 8) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Within (baseline) - above (Day 8) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Within (baseline) - above (Day 8) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Within (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Above (baseline) - within (Day 8) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Neutrophils | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALP | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Within (baseline) - below (Day 8) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Within (baseline) - above (Day 8) | 3 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GGT | Within (baseline) - within (Day 8) | 20 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Below (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Above (baseline) - within (Day 8) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Within (baseline) - within (Day 8) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Within (baseline) - within (Day 8) | 19 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Above (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Below (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Within (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Within (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Within (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Within (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Within (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Within (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Within (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Platelets | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Below (baseline) - within (Day 8) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Within (baseline) - within (Day 8) | 22 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | CREA | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Within (baseline) - within (Day 8) | 22 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Above (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Above (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Below (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Within (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Within (baseline) - below (Day 8) | 2 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hematocrit | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Within (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Within (baseline) - above (Day 8) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Within (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Within (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Within (baseline) - within (Day 8) | 21 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Above (baseline) - within (Day 8) | 3 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Below (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Below (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Within (baseline) - within (Day 8) | 23 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | GLUC | Above (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Above (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Within (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Below (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Above (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Within (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Below (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Hemoglobin | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Within (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Within (baseline) - within (Day 8) | 23 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Within (baseline) - within (Day 8) | 22 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Above (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Erythrocytes | Below (baseline) - below (Day 8) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Within (baseline) - within (Day 8) | 22 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Na | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Within (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Above (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | AST | Within (baseline) - within (Day 8) | 23 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Within (baseline) - within (Day 8) | 22 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Within (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Within (baseline) - above (Day 8) | 1 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Within (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BUN | Below (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Leukocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | LDH | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | K | Within (baseline) - within (Day 8) | 19 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Below (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | ALA | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Above (baseline) - within (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Above (baseline) - above (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Lymphocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | Eosinophils | Within (baseline) - within (Day 8) | 22 Participants |
| Control Group | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | BILI | Within (baseline) - below (Day 8) | 2 Participants |
Primary
Number of Subjects With Reported Reactive Arthritis or Neutropenia (AESIs)
Reactive arthritis is defined as non-purulent joint inflammation that develops in response to an infection in another part of the body. Since the inflammation is triggered by a previous condition, it is termed reactive. Intestinal pathogens that have been associated with reactive arthritis include Campylobacter, Salmonella, Yersinia, Clostridium difficile, and Shigella. If reactive arthritis is caused by an auto immune response, there is at least a possibility that it could be initiated by vaccination of susceptible people with the 1790GAHB vaccine.
Time frame: Throughout the whole study period (from Day 1 up to Day 57)
Population: This analysis was performed on the Unsolicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom unsolicited adverse event data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1790GAHB 25 μg Group | Number of Subjects With Reported Reactive Arthritis or Neutropenia (AESIs) | Reactive Arthritis | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Reported Reactive Arthritis or Neutropenia (AESIs) | Neutropenia | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Reported Reactive Arthritis or Neutropenia (AESIs) | Reactive Arthritis | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Reported Reactive Arthritis or Neutropenia (AESIs) | Neutropenia | 3 Participants |
| Control Group | Number of Subjects With Reported Reactive Arthritis or Neutropenia (AESIs) | Reactive Arthritis | 0 Participants |
| Control Group | Number of Subjects With Reported Reactive Arthritis or Neutropenia (AESIs) | Neutropenia | 1 Participants |
Primary
Number of Subjects With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; is life-threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); it does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions); congenital anomaly/or birth defect; an important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
Time frame: Throughout the whole study period (from Day 1 up to Day 57)
Population: This analysis was performed on the Unsolicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom unsolicited adverse event data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1790GAHB 25 μg Group | Number of Subjects With Serious Adverse Events (SAEs) | Deaths | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Serious Adverse Events (SAEs) | Any SAE | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Serious Adverse Events (SAEs) | Possibly or probably related SAE | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Serious Adverse Events (SAEs) | Possibly or probably related SAE | 3 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Serious Adverse Events (SAEs) | Deaths | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Serious Adverse Events (SAEs) | Any SAE | 3 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) | Any SAE | 1 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) | Deaths | 0 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) | Possibly or probably related SAE | 1 Participants |
Primary
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Assessed solicited local adverse reactions were injection site erythema, induration, pain. Assessed systemic adverse reactions were headache, arthralgia, chills, fatigue, malaise, myalgia and temperature (body temperature measured axillary). Any = occurrence of the symptom regardless of intensity grade. Any temperature = body temperature ≥ 38.0°C. Severe symptom = pain, headache, arthralgia, chills, fatigue, malaise and myalgia that prevented normal activity. Severe redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Severe temperature = body temperature \> 40.0 °C.
Time frame: From 30 minutes up to 7 days following each vaccination
Population: This analysis was performed on the Solicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited adverse event data were available. Less subjects were available to receive the second dose, hence the number or participants analysed is lower for the second dose results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Temperature, post-Dose 2 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Arthralgia, post-Dose 1 | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any adverse event(s) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any solicited local adverse event(s) | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Pain, post-Dose 1 | 20 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Pain, post-Dose 1 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Erythema, post-Dose 1 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Erythema, post-Dose 1 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Induration, post-Dose 1 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Induration, post-Dose 1 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Pain, post-Dose 2 | 15 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Pain, post-Dose 2 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Arthralgia, post-Dose 1 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Fatigue, post-Dose 1 | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Fatigue, post-Dose 1 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Chills, post-Dose 1 | 4 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Chills, post-Dose 1 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Malaise, post-Dose 1 | 3 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Erythema, post-Dose 2 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Erythema, post-Dose 2 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Induration, post-Dose 2 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Induration, post-Dose 2 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Pain, Across doses | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Pain, Across Doses | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Erythema, Across Doses | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Erythema, Across Doses | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Induration, Across Doses | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Induration, Across Doses | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Solicited systemic adverse event(s) | 9 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Headache, post-Dose 1 | 5 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Headache, post-Dose 1 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Malaise, post-Dose 1 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Myalgia, post-Dose 1 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Myalgia, post-Dose 1 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Temperature, post-Dose 1 | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Temperature, post-Dose 1 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Headache, post-Dose 2 | 4 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Headache, post-Dose 2 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Arthralgia, post-Dose 2 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Arthralgia, post-Dose 2 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Fatigue, post-Dose 2 | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Fatigue, post-Dose 2 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Chills, post-Dose 2 | 3 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Chills, post-Dose 2 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Malaise, post-Dose 2 | 2 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Malaise, post-Dose 2 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Myalgia, post-Dose 2 | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Myalgia, post-Dose 2 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Temperature, post-Dose 2 | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Headache, Across Doses | 8 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Headache, Across Doses | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Arthralgia, Across Doses | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Arthralgia, Across Doses | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Fatigue, Across Doses | 3 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Fatigue, Across Doses | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Chills, Across Doses | 5 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Chills, Across Doses | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Malaise, Across Doses | 3 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Malaise, Across Doses | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Temperature, Across Doses | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Myalgia, Across Doses | 1 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Myalgia, Across Doses | 0 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Temperature, Across Doses | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Pain, Across Doses | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Myalgia, Across Doses | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Chills, Across Doses | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Arthralgia, post-Dose 1 | 4 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Myalgia, post-Dose 1 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Headache, Across Doses | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Chills, post-Dose 2 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any adverse event(s) | 25 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Arthralgia, Across Doses | 4 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Fatigue, Across Doses | 9 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any solicited local adverse event(s) | 25 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Temperature, post-Dose 1 | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Solicited systemic adverse event(s) | 16 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Pain, post-Dose 1 | 25 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Erythema, Across Doses | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Malaise, post-Dose 2 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Pain, post-Dose 1 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Temperature, post-Dose 1 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Pain, Across doses | 25 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Erythema, post-Dose 1 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Headache, post-Dose 1 | 10 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Headache, post-Dose 2 | 5 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Erythema, post-Dose 1 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Malaise, Across Doses | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Malaise, post-Dose 2 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Induration, post-Dose 1 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Fatigue, Across Doses | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Headache, post-Dose 2 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Induration, post-Dose 1 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Induration, Across Doses | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Malaise, Across Doses | 3 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Pain, post-Dose 2 | 15 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Erythema, Across Doses | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Myalgia, post-Dose 2 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Pain, post-Dose 2 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Arthralgia, post-Dose 2 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Arthralgia, post-Dose 1 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Arthralgia, Across Doses | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Temperature, Across Doses | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Fatigue, post-Dose 1 | 8 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Arthralgia, post-Dose 2 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Myalgia, post-Dose 2 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Fatigue, post-Dose 1 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Malaise, post-Dose 1 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Chills, Across Doses | 5 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Chills, post-Dose 1 | 4 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Fatigue, post-Dose 2 | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Headache, post-Dose 1 | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Chills, post-Dose 1 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Headache, Across Doses | 13 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Temperature, post-Dose 2 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Malaise, post-Dose 1 | 3 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Induration, Across Doses | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Fatigue, post-Dose 2 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Erythema, post-Dose 2 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Myalgia, post-Dose 1 | 2 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Temperature, Across Doses | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Erythema, post-Dose 2 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Myalgia, Across Doses | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Temperature, post-Dose 2 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Induration, post-Dose 2 | 0 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Chills, post-Dose 2 | 1 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Induration, post-Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Temperature, post-Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Induration, post-Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Pain, Across doses | 19 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Pain, Across Doses | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Headache, Across Doses | 10 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Erythema, Across Doses | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Malaise, Across Doses | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Erythema, Across Doses | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Headache, Across Doses | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Induration, Across Doses | 1 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Temperature, Across Doses | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Induration, Across Doses | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Solicited systemic adverse event(s) | 14 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Arthralgia, Across Doses | 5 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Headache, post-Dose 1 | 8 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Temperature, Across Doses | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Malaise, post-Dose 1 | 6 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Malaise, post-Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Arthralgia, Across Doses | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Myalgia, post-Dose 1 | 2 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Myalgia, post-Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Temperature, post-Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Fatigue, Across Doses | 9 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Temperature, post-Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Myalgia, Across Doses | 6 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Headache, post-Dose 2 | 4 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Headache, post-Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Fatigue, Across Doses | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Arthralgia, post-Dose 2 | 1 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Arthralgia, post-Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Fatigue, post-Dose 2 | 4 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Chills, Across Doses | 5 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Fatigue, post-Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Chills, post-Dose 2 | 2 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Headache, post-Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Arthralgia, post-Dose 1 | 4 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any adverse event(s) | 21 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Chills, post-Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any solicited local adverse event(s) | 19 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Chills, Across Doses | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Pain, post-Dose 1 | 10 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Pain, post-Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Malaise, post-Dose 2 | 4 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Erythema, post-Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Myalgia, Across Doses | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Erythema, post-Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Induration, post-Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Malaise, post-Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Induration, post-Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Pain, post-Dose 2 | 17 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Myalgia, post-Dose 2 | 4 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Arthralgia, post-Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Malaise, Across Doses | 10 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Fatigue, post-Dose 1 | 7 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Fatigue, post-Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Myalgia, post-Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Chills, post-Dose 1 | 3 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Chills, post-Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Pain, post-Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Temperature, post-Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Erythema, post-Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Severe Erythema, post-Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | Any Induration, post-Dose 2 | 1 Participants |
Secondary
Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples
The ratio was expressed as unadjusted geometric mean ratio (GMR) and presented with its 95% confidence interval (CI).
Time frame: At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)
Population: This analysis was performed on the Full Analysis Set, including subjects with at least 1 dose of study vaccine administered. Numbers decreased over time, hence at study Visit 5 (Day 57), not all subjects from study Visit 1 (Day 1) had available immunogenicity results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 1790GAHB 25 μg Group | Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples | At Day 29 versus Day 1 | 2.1 Geometric mean ratio |
| 1790GAHB 25 μg Group | Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples | At Day 57 versus Day 29 | 1.44 Geometric mean ratio |
| 1790GAHB 25 μg Group | Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples | At Day 57 versus Day 1 | 3.1 Geometric mean ratio |
| 1790GAHB 100 μg Group | Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples | At Day 57 versus Day 1 | 4.3 Geometric mean ratio |
| 1790GAHB 100 μg Group | Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples | At Day 57 versus Day 29 | 1.02 Geometric mean ratio |
| 1790GAHB 100 μg Group | Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples | At Day 29 versus Day 1 | 4.43 Geometric mean ratio |
| Control Group | Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples | At Day 57 versus Day 29 | 1.01 Geometric mean ratio |
| Control Group | Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples | At Day 57 versus Day 1 | 1.07 Geometric mean ratio |
| Control Group | Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples | At Day 29 versus Day 1 | 1.06 Geometric mean ratio |
Secondary
Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer
Anti-LPS S.Sonnei IgG ELISA concentrations were tabulated as unadjusted geometric mean concentrations (GMCs) and expressed as ELISA units (EU) per milliliter (mL), presented with their 95% confidence intervals (CIs). Since all subjects in the study were from an endemic country, they had pre-vaccination titers equal to or above (≥) LLOQ (limit of detection).
Time frame: At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)
Population: This analysis was performed on the Full Analysis Set, including subjects with at least 1 dose of study vaccine administered. Numbers decreased over time, hence at study Visit 5 (Day 57), not all subjects from study Visit 1 (Day 1) had available immunogenicity results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 1790GAHB 25 μg Group | Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer | Day 57 | 3030 EU/mL |
| 1790GAHB 25 μg Group | Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer | Day 1 | 971 EU/mL |
| 1790GAHB 25 μg Group | Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer | Day 29 | 2038 EU/mL |
| 1790GAHB 100 μg Group | Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer | Day 57 | 4706 EU/mL |
| 1790GAHB 100 μg Group | Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer | Day 29 | 5301 EU/mL |
| 1790GAHB 100 μg Group | Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer | Day 1 | 1196 EU/mL |
| Control Group | Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer | Day 29 | 1100 EU/mL |
| Control Group | Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer | Day 1 | 994 EU/mL |
| Control Group | Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer | Day 57 | 987 EU/mL |
Secondary
Number of Subjects With Seroresponse to Anti-LPS S. Sonnei IgG ELISA, by Baseline Titer
Seroresponse was defined as: if the baseline value was greater than 50 EU then an increase of at least 50% in the post-vaccination sample as compared to baseline (i.e., \[{post-vac minus baseline}/baseline\]100% ≥ 50%); if the baseline value was less or equal to 50 EU then an increase of at least 25 EU in the post-vaccination sample as compared to baseline (i.e., \[post-vac minus baseline\] ≥ 25 EU). Since all subjects in the study were from an endemic country, they had pre-vaccination titers equal to or above (≥) LLOQ (limit of detection).
Time frame: At Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)
Population: This analysis was based on the Full Analysis Set, including subjects with at least 1 dose of study vaccine administered. Some subjects were excluded due to implausible values from all study visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1790GAHB 25 μg Group | Number of Subjects With Seroresponse to Anti-LPS S. Sonnei IgG ELISA, by Baseline Titer | Anti-LPS, Day 29 | 15 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Seroresponse to Anti-LPS S. Sonnei IgG ELISA, by Baseline Titer | Anti-LPS, Day 57 | 19 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Seroresponse to Anti-LPS S. Sonnei IgG ELISA, by Baseline Titer | Anti-LPS, Day 29 | 25 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Seroresponse to Anti-LPS S. Sonnei IgG ELISA, by Baseline Titer | Anti-LPS, Day 57 | 22 Participants |
| Control Group | Number of Subjects With Seroresponse to Anti-LPS S. Sonnei IgG ELISA, by Baseline Titer | Anti-LPS, Day 29 | 2 Participants |
| Control Group | Number of Subjects With Seroresponse to Anti-LPS S. Sonnei IgG ELISA, by Baseline Titer | Anti-LPS, Day 57 | 1 Participants |
Secondary
Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL
The analysis cut-off value (121 U/mL) was expressed in units per milliliter (U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).
Time frame: At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)
Population: This analysis was performed on the Full Analysis Set, including subjects with at least 1 dose of study vaccine administered. Numbers decreased over time, hence at study Visit 5 (Day 57), not all subjects from study Visit 1 (Day 1) had available immunogenicity results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1790GAHB 25 μg Group | Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL | Day 29 | 22 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL | Day 1 | 21 Participants |
| 1790GAHB 25 μg Group | Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL | Day 57 | 21 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL | Day 29 | 26 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL | Day 1 | 24 Participants |
| 1790GAHB 100 μg Group | Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL | Day 57 | 23 Participants |
| Control Group | Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL | Day 1 | 21 Participants |
| Control Group | Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL | Day 57 | 19 Participants |
| Control Group | Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL | Day 29 | 19 Participants |