RSV Infection
Conditions
Keywords
Monoclonal antibody
Brief summary
Gates MRI-RSM01-101 was a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and tolerability, pharmacokinetics, occurrence of Anti-drug antibody (ADA), and assessment of neutralizing antibody against RSV after administration of single intravenous or intramuscular doses of RSM01 to healthy adults.
Detailed description
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection (LRTI) among infants and young children, resulting in annual epidemics worldwide. RSM01, a monoclonal antibody targeting RSV, may potentially provide an effective method to protect infants from RSV disease based on its potency and an extended half-life that is expected to support once-per-RSV-season administration. This study was a first-in-human evaluation of RSM01 in healthy male and female adults with the goal of characterizing the safety and tolerability of a range of single doses of RSM01 to enable determination of appropriate dose(s) to be administered to infants in a future study. Enrollment was planned at a single study center in the United States. 56 participants were enrolled; 48 participants received RSM01 and 8 participants received Placebo. Participants were followed for approximately 5 months (151 days) after dosing.
Interventions
DRUGRSM01
Cohort 1: RSM01 300 mg IV Cohort 2: RSM01 300 mg IM Cohort 3: RSM01 1000 mg IV Cohort 4: RSM01 3000 mg IV Cohort 5: RSM01 600 mg IM
OTHERPlacebo
Cohort 1: Placebo IV Cohort 2: Placebo IM Cohort 3: Placebo IV Cohort 4: Placebo IV Cohort 5: Placebo IM
Sponsors
PPD Phase I Clinic - Orlando
Gates Medical Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants and all study personnel were blinded to the randomization. Authorized study site personnel would administer doses.
Intervention model description
Randomized, double-blind, placebo-controlled study of RSM01. The study was conducted in 2 parts: A Dose Escalation Phase (28 participants) with 4 dosing cohorts, followed by an Expansion Phase (28 participants) with a single cohort.
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Participant must be 18 to 49 years of age (inclusive), at the time of signing the informed consent. 2. Participant is healthy as determined by medical evaluation including medical history, physical examination and laboratory tests. 3. Body mass index (BMI) 18 to 29.9 kg/m2 (inclusive) 4. Both males and females are eligible to participate. Female participants must not be pregnant, breastfeeding, or attempting to become pregnant for 28 days prior to screening and throughout the duration of the study. Females must be willing to comply with protocol-specified contraception for the duration of their participation in the study and for 90 days following the completion of the study. Male participants with partners of childbearing potential must be willing to comply with protocol specific contraception for the duration of their participation in the study and for 90 days following the completion of the study. Males must also agree to refrain from sperm donation for at least 90 days after they complete the study. 5. Participant must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol 6. Participant agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to relocate from the study area for the duration of the study.
Exclusion criteria
1. Acute illness and/or body temperature ≥37.5°C or ≥99.5°F on Study Day 1. NOTE: This is a temporary exclusion for which the participant may be re-evaluated 2. Evidence and/or history of clinically significant medical condition(s) as judged by the investigator, including malignancies, diabetes mellitus, and unstable or uncontrolled hypertension 3. History of any autoimmune disease or immune deficiency or other impairment to the immune system, including but not limited to HIV, autoimmune conditions, or immunosuppressive therapy. Note: history of Hashimoto's thyroiditis is not an exclusion criterion 4. History of anaphylaxis 5. Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the participant will comply with the protocol 6. Receiving or plans to receive any medications or other therapies that may impact the immune system such as allergy injections, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with major organ toxicity within 90 days prior to Day 1 7. Received any vaccination (including COVID-19 vaccine) within the 15 days before Day 1 or plans to receive a dose of any vaccine during the 15-day period following Day 1 8. Receiving or plans to receive immunosuppressive agents including systemic steroids within 90 days prior to Day 1 (individuals using inhaled or topical corticosteroids, prednisone (or equivalent) dose of ≤ 20 mg/day for ≤ 14 days, and intra-articular corticosteroids are permitted) 9. Received or donated blood or blood products within 90 days prior to Day 1 or plans to receive or donate during the study period 10. Received or plans to receive antibody or biologic therapy within 180 days prior to Day 1 or any time during the study period, whether licensed or investigational (e.g., immunoglobulin products, monoclonal antibodies, or antibody fragments) 11. Participation in an interventional clinical trial and/or receipt of any investigational drug within 30 days or 5 half-lives of the investigational drug before the first day of study drug dosing in this study, whichever is longer. 12. Concurrent enrollment in another interventional study 13. Previously participated and received study intervention in the current study 14. Female participants: positive serum pregnancy test 15. Safety laboratory values outside of normal range, for age and sex that are suggestive of a disease state (Grade 1 abnormalities will not lead to exclusion if the investigator considers them not clinically significant.) 16. Urinalysis abnormality greater than Grade 1 (with the exception of hematuria in a menstruating female), or urinalysis abnormality judged clinically significant by the investigator 17. Clinically significant ECG abnormalities 18. Reactive HIV antibody testing 19. Current hepatitis B and/or hepatitis C infection 20. Positive urine drug screen at screening or Day -1 (with the exception of prescribed drugs) 21. History of allergy or hypersensitivity to the study drug, excipients or related substances 22. Female participants with any one of the following conditions: currently pregnant or lactating/nursing; has positive serum pregnancy test during the Screening Phase, planning a pregnancy within 1 year after first dose of study drug 23. Acting as study personnel or immediate family members (brother, sister, child, parent) or the spouse/partner of study personnel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Unsolicited Treatment Emergent Adverse Events (TEAEs) Through Day 151 | Day 1 through Day 151 | A TEAE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A memory aid was utilized by participants to collect unsolicited TEAEs beginning at discharge from the clinic, through Day 151. Participants were instructed to record unsolicited TEAEs whenever they occurred, recording such TEAEs on the memory aid. The memory aids were collected and reviewed by site staff at each subsequent visit through the end of the study. Number of participants with unsolicited TEAEs through Day 151 has been presented. |
| Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151 | Day 1 through Day 151 | An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. AESIs were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Number of participants with SAEs and AESIs through Day 151 has been presented. |
| Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Through Day 7 | Solicited systemic AEs were defined events that participants were specifically asked about and which were noted by participants in the diary card. Systemic solicited AEs included fever, headache, tiredness, joint pain, muscle pain, nausea, vomiting and diarrhea. Number of participants with solicited systemic AEs for 7 days after dose administration has been presented. |
| Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration | Up to Day 7 | Solicited local AEs were defined events that participants were specifically asked about and which were noted by participants in the diary card. Solicited local AEs for injection site reactions included AEs include pain, redness and swelling. Number of participants with solicited local AEs for injection site reactions for 7 days after intramuscular dose administration has been presented |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Day 91 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D91) After Administration of RSM01 | Day 91 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. |
| Day 151 Capillary Blood-concentration (CD151) After Administration of RSM01 | Day 151 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. |
| Day 151 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D151) After Administration of RSM01 | Day 151 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. |
| Maximum Capillary Blood Concentration (Cmax) After Administration of RSM01 | Day 151 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. |
| Minimum Capillary Blood Concentration (Cmin) After Administration of RSM01 | Day 151 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. |
| Time to Maximum Capillary Blood-concentration (Tmax) After Administration of RSM01 | Day 151 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. |
| Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Through Day 151 | Blood samples were collected for the assessment of hemoglobin, platelets, leukocytes, neutrophils and lymphocytes. Laboratory grades were evaluated using the Food and Drug administration (FDA) Toxicity Grading Scale with grading as: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening or disabling. Number of participants with clinically significant hematology assessments of Grade 1 and above has been presented. |
| Total Body Clearance (CL) After Intravenous Dose Administration of RSM01 | Day 151 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. CL post intravenous administration in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics. |
| Apparent Total Body Clearance (CL) After Intramuscular Dose Administration of RSM01 | Day 151 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. Total body CL post intramuscular administration in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics. |
| Volume of Distribution (Vz) After Intravenous Dose Administration of RSM01 | Day 151 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. Vz post intravenous administration in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics. |
| Apparent Volume of Distribution (Vz) After Intramuscular Dose Administration of RSM01 | Day 151 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. Vz post intramuscular administration in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics. |
| Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration | Baseline (Day 1) and post-Baseline through Day 151 | Whole blood samples in serum separator tubes and volumetric absorptive microsampling (VAMS) samples were collected for detection of ADAs against RSM01 in serum and capillary blood, respectively. The detection of ADA to RSM01 was performed using a validated immunoassay method with tiered testing of screening, confirmatory, and titration. Number of participants with positive ADAs at Baseline and post-Baseline through Day 151 following RSM01 administration has been presented. |
| Apparent Terminal Half-Life After Administration of RSM01 | Day 151 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. Apparent terminal half-life in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics. |
| Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Through Day 151 | Blood samples were collected for the assessment of Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Gamma Glutamyl Transferase, Creatinine, Urea nitrogen, Glucose, Albumin, Sodium and Potassium. Laboratory grades were evaluated using the FDA Toxicity Grading Scale with grading as: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening or disabling. Number of participants with clinically significant clinical chemistry assessments of Grade 1 and above has been presented. |
| Area Under the Capillary Blood-concentration Time Curve From Zero to Infinity (AUC 0-infinity) After Administration of RSM01 | Day 151 | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. AUC(0-infinity) in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics. |
| Day 91 Capillary Blood-concentration (CD91) After Administration of RSM01 | Day 91 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. |
Countries
United States
Participant flow
Recruitment details
The study was conducted in United States
Pre-assignment details
The study was conducted in 2 parts: Dose Escalation Phase followed by an Expansion Phase. Participants were randomized 6:1 to RSM01 or Placebo in each dose cohort. Results are presented by intervention.
Participants by arm
| Arm | Count |
|---|---|
| RSM01 300 mg IV Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV | 6 |
| RSM01 300 mg IM Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM | 6 |
| RSM01 1000 mg IV Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV | 6 |
| RSM01 3000 mg IV Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV | 6 |
| RSM01 600 mg IM Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM | 24 |
| Placebo Participants randomized to Placebo within the dose cohorts are pooled. | 8 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Dose Escalation Phase (Day 1 to Day 151) | Lost to Follow-up | 0 | 0 | 0 | 2 | 0 | 0 |
| Dose Expansion Phase (Day 1 to Day 151) | Unspecified Reason Not Completed | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | RSM01 300 mg IV | RSM01 300 mg IM | RSM01 1000 mg IV | RSM01 3000 mg IV | RSM01 600 mg IM |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 30.9 Years STANDARD_DEVIATION 5.33 | 31.6 Years STANDARD_DEVIATION 8.13 | 28.2 Years STANDARD_DEVIATION 4.26 | 30.7 Years STANDARD_DEVIATION 9.4 | 31.5 Years STANDARD_DEVIATION 8.76 | 27.5 Years STANDARD_DEVIATION 9.54 | 34.1 Years STANDARD_DEVIATION 8.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 29 Participants | 2 Participants | 3 Participants | 4 Participants | 6 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 27 Participants | 4 Participants | 3 Participants | 2 Participants | 0 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 14 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 4 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 37 Participants | 4 Participants | 4 Participants | 3 Participants | 5 Participants | 16 Participants |
| Sex: Female, Male Female | 5 Participants | 27 Participants | 1 Participants | 3 Participants | 5 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Male | 3 Participants | 29 Participants | 5 Participants | 3 Participants | 1 Participants | 4 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 24 | 0 / 8 |
| other Total, other adverse events | 1 / 6 | 2 / 6 | 3 / 6 | 3 / 6 | 3 / 24 | 2 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 24 | 0 / 8 |
Outcome results
Primary
Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151
An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. AESIs were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Number of participants with SAEs and AESIs through Day 151 has been presented.
Time frame: Day 1 through Day 151
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSM01 300 mg IV | Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151 | SAEs | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151 | AESI | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151 | SAEs | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151 | AESI | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151 | SAEs | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151 | AESI | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151 | SAEs | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151 | AESI | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151 | SAEs | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151 | AESI | 0 Participants |
| Placebo | Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151 | SAEs | 0 Participants |
| Placebo | Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151 | AESI | 0 Participants |
Primary
Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration
Solicited local AEs were defined events that participants were specifically asked about and which were noted by participants in the diary card. Solicited local AEs for injection site reactions included AEs include pain, redness and swelling. Number of participants with solicited local AEs for injection site reactions for 7 days after intramuscular dose administration has been presented
Time frame: Up to Day 7
Population: Safety Population. Data has been presented only for participants who received RSM01 and placebo intramuscularly.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSM01 300 mg IV | Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration | Redness | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration | Pain | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration | Swelling | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration | Redness | 2 Participants |
| RSM01 300 mg IM | Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration | Pain | 2 Participants |
| RSM01 300 mg IM | Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration | Swelling | 1 Participants |
| RSM01 1000 mg IV | Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration | Pain | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration | Swelling | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration | Redness | 0 Participants |
Primary
Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration
Solicited systemic AEs were defined events that participants were specifically asked about and which were noted by participants in the diary card. Systemic solicited AEs included fever, headache, tiredness, joint pain, muscle pain, nausea, vomiting and diarrhea. Number of participants with solicited systemic AEs for 7 days after dose administration has been presented.
Time frame: Through Day 7
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSM01 300 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Vomiting | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Joint pain | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Diarrhea | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Fever | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Headache | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Nausea | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Tiredness | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Muscle pain | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Tiredness | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Vomiting | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Diarrhea | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Headache | 2 Participants |
| RSM01 300 mg IM | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Joint pain | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Fever | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Nausea | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Muscle pain | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Nausea | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Vomiting | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Headache | 2 Participants |
| RSM01 1000 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Diarrhea | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Tiredness | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Fever | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Joint pain | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Muscle pain | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Tiredness | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Headache | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Nausea | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Muscle pain | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Diarrhea | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Vomiting | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Fever | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Joint pain | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Headache | 1 Participants |
| RSM01 600 mg IM | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Joint pain | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Fever | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Tiredness | 2 Participants |
| RSM01 600 mg IM | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Muscle pain | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Nausea | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Vomiting | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Diarrhea | 0 Participants |
| Placebo | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Diarrhea | 0 Participants |
| Placebo | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Vomiting | 0 Participants |
| Placebo | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Joint pain | 0 Participants |
| Placebo | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Tiredness | 0 Participants |
| Placebo | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Headache | 0 Participants |
| Placebo | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Fever | 1 Participants |
| Placebo | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Nausea | 0 Participants |
| Placebo | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | Muscle pain | 0 Participants |
Primary
Number of Participants With Unsolicited Treatment Emergent Adverse Events (TEAEs) Through Day 151
A TEAE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A memory aid was utilized by participants to collect unsolicited TEAEs beginning at discharge from the clinic, through Day 151. Participants were instructed to record unsolicited TEAEs whenever they occurred, recording such TEAEs on the memory aid. The memory aids were collected and reviewed by site staff at each subsequent visit through the end of the study. Number of participants with unsolicited TEAEs through Day 151 has been presented.
Time frame: Day 1 through Day 151
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSM01 300 mg IV | Number of Participants With Unsolicited Treatment Emergent Adverse Events (TEAEs) Through Day 151 | 1 Participants |
| RSM01 300 mg IM | Number of Participants With Unsolicited Treatment Emergent Adverse Events (TEAEs) Through Day 151 | 2 Participants |
| RSM01 1000 mg IV | Number of Participants With Unsolicited Treatment Emergent Adverse Events (TEAEs) Through Day 151 | 3 Participants |
| RSM01 3000 mg IV | Number of Participants With Unsolicited Treatment Emergent Adverse Events (TEAEs) Through Day 151 | 3 Participants |
| RSM01 600 mg IM | Number of Participants With Unsolicited Treatment Emergent Adverse Events (TEAEs) Through Day 151 | 3 Participants |
| Placebo | Number of Participants With Unsolicited Treatment Emergent Adverse Events (TEAEs) Through Day 151 | 2 Participants |
Secondary
Apparent Terminal Half-Life After Administration of RSM01
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. Apparent terminal half-life in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics.
Time frame: Day 151
Population: PK population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RSM01 300 mg IV | Apparent Terminal Half-Life After Administration of RSM01 | 653 Hours |
| RSM01 300 mg IM | Apparent Terminal Half-Life After Administration of RSM01 | 439 Hours |
| RSM01 1000 mg IV | Apparent Terminal Half-Life After Administration of RSM01 | 1310 Hours |
| RSM01 3000 mg IV | Apparent Terminal Half-Life After Administration of RSM01 | 1060 Hours |
| RSM01 600 mg IM | Apparent Terminal Half-Life After Administration of RSM01 | 1480 Hours |
Secondary
Apparent Total Body Clearance (CL) After Intramuscular Dose Administration of RSM01
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. Total body CL post intramuscular administration in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics.
Time frame: Day 151
Population: PK population. Only those participants with data available at the specified data points were analyzed. Data has been presented only for participants who received RSM01 intramuscularly.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RSM01 300 mg IV | Apparent Total Body Clearance (CL) After Intramuscular Dose Administration of RSM01 | 12.0 Milliliter per hour (mL/h) | Standard Deviation 2.77 |
| RSM01 300 mg IM | Apparent Total Body Clearance (CL) After Intramuscular Dose Administration of RSM01 | 5.68 Milliliter per hour (mL/h) | — |
Secondary
Apparent Volume of Distribution (Vz) After Intramuscular Dose Administration of RSM01
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. Vz post intramuscular administration in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics.
Time frame: Day 151
Population: PK population. Only those participants with data available at the specified data points were analyzed. Data has been presented only for participants who received RSM01 intramuscularly.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| RSM01 300 mg IV | Apparent Volume of Distribution (Vz) After Intramuscular Dose Administration of RSM01 | 7610 Milliliter (mL) | Standard Deviation 1740 |
| RSM01 300 mg IM | Apparent Volume of Distribution (Vz) After Intramuscular Dose Administration of RSM01 | 12200 Milliliter (mL) | — |
Secondary
Area Under the Capillary Blood-concentration Time Curve From Zero to Infinity (AUC 0-infinity) After Administration of RSM01
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. AUC(0-infinity) in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics.
Time frame: Day 151
Population: Pharmacokinetic (PK) population: included all participants who received the study intervention. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RSM01 300 mg IV | Area Under the Capillary Blood-concentration Time Curve From Zero to Infinity (AUC 0-infinity) After Administration of RSM01 | 25700000 Hours*nanograms per milliliter (h*ng/mL) | — |
| RSM01 300 mg IM | Area Under the Capillary Blood-concentration Time Curve From Zero to Infinity (AUC 0-infinity) After Administration of RSM01 | 25300000 Hours*nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 23.6 |
| RSM01 1000 mg IV | Area Under the Capillary Blood-concentration Time Curve From Zero to Infinity (AUC 0-infinity) After Administration of RSM01 | 239000000 Hours*nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 26.4 |
| RSM01 3000 mg IV | Area Under the Capillary Blood-concentration Time Curve From Zero to Infinity (AUC 0-infinity) After Administration of RSM01 | 1010000000 Hours*nanograms per milliliter (h*ng/mL) | — |
| RSM01 600 mg IM | Area Under the Capillary Blood-concentration Time Curve From Zero to Infinity (AUC 0-infinity) After Administration of RSM01 | 106000000 Hours*nanograms per milliliter (h*ng/mL) | — |
Secondary
Day 151 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D151) After Administration of RSM01
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Day 151
Population: PK population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RSM01 300 mg IV | Day 151 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D151) After Administration of RSM01 | 68700000 Hours*nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 53.8 |
| RSM01 300 mg IM | Day 151 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D151) After Administration of RSM01 | 48400000 Hours*nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 69.3 |
| RSM01 1000 mg IV | Day 151 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D151) After Administration of RSM01 | 278000000 Hours*nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 27.5 |
| RSM01 3000 mg IV | Day 151 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D151) After Administration of RSM01 | 813000000 Hours*nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 22.9 |
| RSM01 600 mg IM | Day 151 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D151) After Administration of RSM01 | 114000000 Hours*nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 48.3 |
Secondary
Day 151 Capillary Blood-concentration (CD151) After Administration of RSM01
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Day 151
Population: PK population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RSM01 300 mg IV | Day 151 Capillary Blood-concentration (CD151) After Administration of RSM01 | 13500 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 13.4 |
| RSM01 300 mg IM | Day 151 Capillary Blood-concentration (CD151) After Administration of RSM01 | 12100 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 8.2 |
| RSM01 1000 mg IV | Day 151 Capillary Blood-concentration (CD151) After Administration of RSM01 | 36800 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 58.8 |
| RSM01 3000 mg IV | Day 151 Capillary Blood-concentration (CD151) After Administration of RSM01 | 105000 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 32.7 |
| RSM01 600 mg IM | Day 151 Capillary Blood-concentration (CD151) After Administration of RSM01 | 17900 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 76.8 |
Secondary
Day 91 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D91) After Administration of RSM01
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Day 91
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RSM01 300 mg IV | Day 91 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D91) After Administration of RSM01 | 50900000 Hours*nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 42 |
| RSM01 300 mg IM | Day 91 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D91) After Administration of RSM01 | 40600000 Hours*nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 44.3 |
| RSM01 1000 mg IV | Day 91 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D91) After Administration of RSM01 | 207000000 Hours*nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 22.8 |
| RSM01 3000 mg IV | Day 91 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D91) After Administration of RSM01 | 549000000 Hours*nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 17.3 |
| RSM01 600 mg IM | Day 91 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D91) After Administration of RSM01 | 85400000 Hours*nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 39.3 |
Secondary
Day 91 Capillary Blood-concentration (CD91) After Administration of RSM01
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Day 91
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RSM01 300 mg IV | Day 91 Capillary Blood-concentration (CD91) After Administration of RSM01 | 14500 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 83.5 |
| RSM01 300 mg IM | Day 91 Capillary Blood-concentration (CD91) After Administration of RSM01 | 8020 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 209.6 |
| RSM01 1000 mg IV | Day 91 Capillary Blood-concentration (CD91) After Administration of RSM01 | 63400 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 38.8 |
| RSM01 3000 mg IV | Day 91 Capillary Blood-concentration (CD91) After Administration of RSM01 | 196000 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 25.9 |
| RSM01 600 mg IM | Day 91 Capillary Blood-concentration (CD91) After Administration of RSM01 | 27600 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 76.7 |
Secondary
Maximum Capillary Blood Concentration (Cmax) After Administration of RSM01
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Day 151
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RSM01 300 mg IV | Maximum Capillary Blood Concentration (Cmax) After Administration of RSM01 | 62200 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 20.3 |
| RSM01 300 mg IM | Maximum Capillary Blood Concentration (Cmax) After Administration of RSM01 | 31500 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 17.6 |
| RSM01 1000 mg IV | Maximum Capillary Blood Concentration (Cmax) After Administration of RSM01 | 264000 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 18.2 |
| RSM01 3000 mg IV | Maximum Capillary Blood Concentration (Cmax) After Administration of RSM01 | 652000 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 13.8 |
| RSM01 600 mg IM | Maximum Capillary Blood Concentration (Cmax) After Administration of RSM01 | 56400 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 23.9 |
Secondary
Minimum Capillary Blood Concentration (Cmin) After Administration of RSM01
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Day 151
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RSM01 300 mg IV | Minimum Capillary Blood Concentration (Cmin) After Administration of RSM01 | 13500 Nanograms per milliliter (Ng/mL) | Geometric Coefficient of Variation 13.4 |
| RSM01 300 mg IM | Minimum Capillary Blood Concentration (Cmin) After Administration of RSM01 | 3670 Nanograms per milliliter (Ng/mL) | Geometric Coefficient of Variation 68.9 |
| RSM01 1000 mg IV | Minimum Capillary Blood Concentration (Cmin) After Administration of RSM01 | 36100 Nanograms per milliliter (Ng/mL) | Geometric Coefficient of Variation 56.7 |
| RSM01 3000 mg IV | Minimum Capillary Blood Concentration (Cmin) After Administration of RSM01 | 127000 Nanograms per milliliter (Ng/mL) | Geometric Coefficient of Variation 38.7 |
| RSM01 600 mg IM | Minimum Capillary Blood Concentration (Cmin) After Administration of RSM01 | 18700 Nanograms per milliliter (Ng/mL) | Geometric Coefficient of Variation 78.5 |
Secondary
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Blood samples were collected for the assessment of Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Gamma Glutamyl Transferase, Creatinine, Urea nitrogen, Glucose, Albumin, Sodium and Potassium. Laboratory grades were evaluated using the FDA Toxicity Grading Scale with grading as: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening or disabling. Number of participants with clinically significant clinical chemistry assessments of Grade 1 and above has been presented.
Time frame: Through Day 151
Population: Safety Population. Only those participants with data available at specified time points has been presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 4 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 4 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 3 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 3 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 2 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 3 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 4 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 1 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 2 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 3 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 1 | 1 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 3 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 2 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 2 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 4 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 4 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 1 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 2 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 4 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 3 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 2 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 1 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 3 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 3 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 1 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 1 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 4 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 3 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 2 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 3 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 1 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 2 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 4 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 2 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 2 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 1 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 1 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 1 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 2 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 3 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 4 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 4 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 4 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 1 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 4 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 2 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 3 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 1 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 4 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 2 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 1 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 4 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 2 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 3 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 1 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 1 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 2 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 4 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 3 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 4 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 4 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 3 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 1 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 2 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 2 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 3 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 1 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 1 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 4 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 2 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 1 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 3 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 4 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 2 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 3 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 3 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 3 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 4 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 2 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 1 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 1 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 2 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 3 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 4 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 3 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 1 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 4 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 2 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 3 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 4 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 3 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 4 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 4 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 2 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 3 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 3 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 3 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 2 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 4 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 2 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 1 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 1 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 1 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 1 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 3 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 1 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 1 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 2 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 1 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 3 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 4 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 2 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 3 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 1 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 2 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 4 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 3 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 3 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 4 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 2 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 2 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 1 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 4 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 1 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 2 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 2 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 4 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 2 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 1 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 4 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 3 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 3 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 1 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 2 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 3 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 1 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 2 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 3 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 1 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 2 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 1 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 1 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 2 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 3 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 1 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 2 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 3 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 1 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 2 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 3 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 1 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 2 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 3 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 1 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 2 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 3 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 1 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 2 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 3 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 1 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 2 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 3 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 2 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 3 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 2 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 2 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 3 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 2 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 1 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 4 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 3 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 3 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 2 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 4 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 2 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 1 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 1 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 4 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 3 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 2 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 3 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 2 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 3 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 1 | 1 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 4 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 4 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 3 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 4 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 1 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 2 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 1 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 2 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 1 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 4 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 3 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 3 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 4 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 1 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 4 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 2 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 1 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 3 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 1 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 2 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 4 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 4 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 3 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 1 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 2 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 1 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 1 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 2 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 1 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 2 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 1 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 4 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 1 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 2 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 4 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 1 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 2 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 4 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 4 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 2 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Urea nitrogen: Grade 1 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 2 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alkaline Phosphatase: Grade 1 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 4 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 1 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 4 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 4 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 4 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 2 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 2 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 2 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Glucose: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Bilirubin: Grade 2 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Creatinine: Grade 1 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Aspartate Aminotransferase: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Gamma Glutamyl Transferase: Grade 4 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Albumin: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Potassium: Grade 4 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Sodium: Grade 1 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | Alanine Aminotransferase: Grade 4 | 0 Participants |
Secondary
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Blood samples were collected for the assessment of hemoglobin, platelets, leukocytes, neutrophils and lymphocytes. Laboratory grades were evaluated using the Food and Drug administration (FDA) Toxicity Grading Scale with grading as: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening or disabling. Number of participants with clinically significant hematology assessments of Grade 1 and above has been presented.
Time frame: Through Day 151
Population: Safety Population. Only those participants with data available at specified time points has been presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 2 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 1 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 3 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 1 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 1 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 4 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 3 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 4 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 4 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 4 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 3 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 1 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 1 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 4 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 3 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 2 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 2 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 2 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 3 | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 2 | 1 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 3 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 4 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 3 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 2 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 2 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 1 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 4 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 1 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 3 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 1 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 2 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 4 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 4 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 3 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 4 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 3 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 1 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 2 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 2 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 1 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 3 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 4 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 1 | 1 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 2 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 1 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 2 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 3 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 4 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 1 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 2 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 3 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 4 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 1 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 2 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 3 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 4 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 1 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 2 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 3 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 2 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 2 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 3 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 1 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 1 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 3 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 1 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 2 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 3 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 4 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 3 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 2 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 2 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 3 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 1 | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 1 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 4 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 1 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 4 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 3 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 3 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 2 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 1 | 2 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 2 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 1 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 4 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 3 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 4 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 1 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 2 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 2 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 3 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 1 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 4 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 2 | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 1 | 2 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 2 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 1 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 4 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 1 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 2 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 4 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Leukocytes: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 4 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 4 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 2 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 1 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Neutrophils: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Platelets: Grade 2 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 2 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Hemoglobin: Grade 4 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | Lymphocytes: Grade 1 | 0 Participants |
Secondary
Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration
Whole blood samples in serum separator tubes and volumetric absorptive microsampling (VAMS) samples were collected for detection of ADAs against RSM01 in serum and capillary blood, respectively. The detection of ADA to RSM01 was performed using a validated immunoassay method with tiered testing of screening, confirmatory, and titration. Number of participants with positive ADAs at Baseline and post-Baseline through Day 151 following RSM01 administration has been presented.
Time frame: Baseline (Day 1) and post-Baseline through Day 151
Population: Immunogenicity Population: all participants who received the study intervention and have at least one valid ADA result
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSM01 300 mg IV | Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration | Baseline | 0 Participants |
| RSM01 300 mg IV | Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration | Post-Baseline Through Day 151 | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration | Baseline | 0 Participants |
| RSM01 300 mg IM | Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration | Post-Baseline Through Day 151 | 0 Participants |
| RSM01 1000 mg IV | Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration | Baseline | 1 Participants |
| RSM01 1000 mg IV | Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration | Post-Baseline Through Day 151 | 2 Participants |
| RSM01 3000 mg IV | Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration | Baseline | 0 Participants |
| RSM01 3000 mg IV | Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration | Post-Baseline Through Day 151 | 1 Participants |
| RSM01 600 mg IM | Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration | Baseline | 0 Participants |
| RSM01 600 mg IM | Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration | Post-Baseline Through Day 151 | 0 Participants |
| Placebo | Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration | Baseline | 0 Participants |
| Placebo | Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration | Post-Baseline Through Day 151 | 0 Participants |
Secondary
Time to Maximum Capillary Blood-concentration (Tmax) After Administration of RSM01
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Day 151
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RSM01 300 mg IV | Time to Maximum Capillary Blood-concentration (Tmax) After Administration of RSM01 | 1.300 Hours |
| RSM01 300 mg IM | Time to Maximum Capillary Blood-concentration (Tmax) After Administration of RSM01 | 140.458 Hours |
| RSM01 1000 mg IV | Time to Maximum Capillary Blood-concentration (Tmax) After Administration of RSM01 | 1.808 Hours |
| RSM01 3000 mg IV | Time to Maximum Capillary Blood-concentration (Tmax) After Administration of RSM01 | 2.208 Hours |
| RSM01 600 mg IM | Time to Maximum Capillary Blood-concentration (Tmax) After Administration of RSM01 | 193.508 Hours |
Secondary
Total Body Clearance (CL) After Intravenous Dose Administration of RSM01
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. CL post intravenous administration in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics.
Time frame: Day 151
Population: PK population. Only those participants with data available at the specified data points were analyzed. Data has been presented only for participants who received RSM01 intravenously
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RSM01 300 mg IV | Total Body Clearance (CL) After Intravenous Dose Administration of RSM01 | 11.7 Milliliter per hour (mL/h) | — |
| RSM01 300 mg IM | Total Body Clearance (CL) After Intravenous Dose Administration of RSM01 | 4.25 Milliliter per hour (mL/h) | Standard Deviation 1.09 |
| RSM01 1000 mg IV | Total Body Clearance (CL) After Intravenous Dose Administration of RSM01 | 2.98 Milliliter per hour (mL/h) | — |
Secondary
Volume of Distribution (Vz) After Intravenous Dose Administration of RSM01
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. Vz post intravenous administration in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics.
Time frame: Day 151
Population: PK population. Only those participants with data available at the specified data points were analyzed. Data has been presented only for participants who received RSM01 intravenously
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| RSM01 300 mg IV | Volume of Distribution (Vz) After Intravenous Dose Administration of RSM01 | 11000 Milliliter (mL) | — |
| RSM01 300 mg IM | Volume of Distribution (Vz) After Intravenous Dose Administration of RSM01 | 7920 Milliliter (mL) | Standard Deviation 1310 |
| RSM01 1000 mg IV | Volume of Distribution (Vz) After Intravenous Dose Administration of RSM01 | 4550 Milliliter (mL) | — |