Autoimmune Hepatitis
Conditions
Keywords
sPIF, synthetic PreImplantation Factor, Autoimmune, Liver, Hepatitis
Brief summary
The purpose of this study is to study the safety and tolerability of synthetic PreImplantation Factor (sPIF) in female patients with autoimmune hepatitis. Autoimmune hepatitis is a disease where the patient's immune system produces an inappropriate immune response against their own liver. PreImplantation Factor is a substance that is secreted by viable fetuses during pregnancy. PIF apparently initiates both maternal tolerance preventing the loss/rejection of the fetus. Synthetic PIF (sPIF) successfully translates PIF endogenous properties to pregnant and non-pregnant immune disorders. sPIF was found to be effective in preclinical models of autoimmunity and transplantation (published). Specifically sPIF protected the liver against immune attack. Toxicity studies (mice, dogs) have shown that high-dose sPIF administration for 2 weeks followed by 2 weeks observation period demonstrated a high safety profile. This study will evaluate the safety, tolerability and the blood level of this synthetic version of this natural compound in the circulation.
Detailed description
Both sPIF as well as natural PIF appears to orchestrate a complex series of cytokine effects that overall appear to cause return of proper immune function and regulation rather than a nonspecific immune suppression. PIF acts on both the innate and adaptive arms of the immune system in a dynamic, diverse and synergetic manner per need. In the pregnancy setting, PIF maintains basal immunity required for embryo and maternal survival, and aids in tolerance for self by blocking activated T cells proliferation that would otherwise harm the embryo. The activity of PIF appears to have a dual complementary mode of action that is dependent on whether the immune system is in the basal or the stimulated immune state. The sPIF concentrations that were used are in the same range as those that are present in maternal circulation of viable pregnancy. sPIF targets three major intracellular proteins that pivotal in autoimmune control.
Interventions
DRUGsPIF
DRUGPlacebo
Sponsors
BioIncept LLC
Christopher O'Brien, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Female, aged from 18 to 70 years old, of non-child bearing potential (to avoid the possibility if antibodies are formed to sPIF this could put the patient at risk for future fertility) * Females must be either * Postmenopausal for greater than two years, * Postmenopausal for less than two years with an follicle stimulating hormone (FSH) level greater \> 40 million international units per milliliter (mIU/mL ) * Or documented as surgically sterile (bilateral tubal ligation, bilateral oophorectomy or post-hysterectomy) at least three months prior to the screening evaluation * Autoimmune hepatitis as documented by a: * Pretreatment score ≥15 * Or a post-treatment score of ≥17 on the International Criteria for the Diagnosis of Autoimmune Hepatitis (Appendix 2) * Treatment with prednisone and/or other oral, immunosuppressive drug(s) must have been stabilized for at least 6 weeks prior to screening for this study. * Stable ALT levels with a fixed dose of their immunosuppressant medications * Subjects do not have to have had a documented relapse after completion of an initial course of therapy * Permitted concomitant immunosuppressant medications will include * Azathioprine dose equal to/or less 100 mg per day, * Budesonide dose equal to/or less 9 mg per day, * Mycophenolate mofetil equal to/or less 3000 mg per day, * Prednisone equal to/or less than 10 mg per day * Ursodeoxycholic acid equal to/or less than 1000 mg per day * In the judgment of the Investigator, be in reasonable general health, based on review of the results of a screening evaluation (to include physical examination, measurement of vital signs, 12-lead ECG trace and the collection of blood and urine for routine clinical laboratory testing), performed no more than 30 days prior to Day 1 of study. * Patients must agree to abstain from alcohol use during their participation in the study protocol. * Alanine aminotransferase (ALT) levels of no more than five times the upper limit of normal (reference) range (ULN) at the screening evaluation. * Normal renal function as determined by a serum creatinine * A female of childbearing potential who is documented as either surgically sterile (bilateral tubal ligation, bilateral oophorectomy or post-hysterectomy at least 3 months prior to the screening evaluation) or post-menopausal for ≥ 2 years.
Exclusion criteria
* Any other forms of chronic liver disease. * Decompensated liver disease defined on the basis of any one of the following laboratory parameters at the screening evaluation: total bilirubin \> 1.5 × ULN, prothrombin time \> 1.2 × ULN, platelets ≤ 100,000/mm3, or albumin \< 3 g/dL OR current or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy or variceal hemorrhage). * Hemoglobin \< 11 g/dL at the screening evaluation. * Serological evidence of infection with HIV upon review of the medical record. * Evidence of hepatocellular carcinoma (i.e., screening α-fetoprotein \> 50 ng/mL or other standard of care measure). * Subjects with, or a history of clinically significant oncologic, pulmonary, hepatic, gastrointestinal, renal, other cardiovascular, hematologic, metabolic, endocrine, neurologic, immunologic or hematologic illness or any other major medical disorder that, in the judgment of the Investigator, would interfere with subject treatment, assessment or compliance with the protocol or should otherwise preclude their participation in this trial. * Have received therapy with potentially hepatotoxic drugs within 3 months (90 days) prior to Day 1 or are expected to receive such therapy during the study. * Patient who are expected to receive a change in their immunosuppressant therapies during the protocol. * Patients who may receive chemotherapeutic agents (e.g., corticosteroids, immunoglobulins and other immune- or cytokine-based therapies) during the study for any other medical condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | 29 Day | Single Ascending Dose (SAD): Adverse events, concomitant medications: Days 1, 2, 3, 5, 8 Vital signs, Physical exams: Days 1, 2, 8 Complete blood counts (CBC), Serum chemistry, Liver function tests, Pharmacokinetics: Days 1, 2, 8 Lipids, Coagulation, Urinalysis, Pregnancy test: Days 1, 8 EKG, chest x-ray (CXR): Days 1 and 8 Multiple Ascending Dose (MAD): Adverse events, concomitant medications: Days 1, 2, 3, 4, 5, 8, 15, 29 Vital signs, Physical exams: Days 1, 2, 3, 4, 5, 8, 15, 29 CBC, Serum chemistry, Liver function tests, Pharmacokinetics: Days 1, 3, 5, 8, 15, 29 Lipids, Coagulation, Urinalysis, Pregnancy test, EKG: Days 1, 5, 29 CXR: Days 1, 29 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anti-sPIF Antibodies and Drug Interactions | 29 Day | Following sPIF administration, using a validated assay, serum samples were tested for anti-sPIF antibodies |
Countries
United States
Participant flow
Recruitment details
sPIF (0.1, 0.5, or 1.0 mg/kg) given single SQ for 5 consecutive days. In SAD, n=18 randomized in a 2:1 sPIF/placebo ratio. 9 patients normal liver function and 9 abnormal liver function. In MAD, n=18 randomized in a 2:1 sPIF/placebo ratio. 9 patients normal liver function and 9 abnormal liver function. N=36 completed the study. total screened 36
Participants by arm
| Arm | Count |
|---|---|
| SAD sPIF 0.1 single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.1 mg/kg sPIF or Placebo Day 1 | 6 |
| SAD sPIF 0.5 single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.5 mg/kg sPIF or Placebo Day 1 | 6 |
| SAD sPIF 1.0 single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 1.0 mg/kg sPIF or Placebo Day 1 | 6 |
| MAD sPIF 0.1 multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug : placebo) to multiple 0.1 mg/kg sPIF doses of sPIF administered subcutaneously once a day for 5 consecutive days (Days 1 to 5) | 6 |
| MAD sPIF 0.5 multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug : placebo) to multiple 0.5 mg/kg sPIF doses of sPIF administered subcutaneously once a day for 5 consecutive days (Days 1 to 5) | 6 |
| MAD sPIF 1.0 multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug : placebo) to multiple 1.0 mg/kg sPIF doses of sPIF administered subcutaneously once a day for 5 consecutive days (Days 1 to 5) | 6 |
| Total | 36 |
Baseline characteristics
| Characteristic | SAD sPIF 0.5 | SAD sPIF 1.0 | MAD sPIF 0.1 | SAD sPIF 0.1 | MAD sPIF 0.5 | MAD sPIF 1.0 | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 5 Participants | 29 Participants |
| Age, Continuous | 59 years STANDARD_DEVIATION 8 | 59 years STANDARD_DEVIATION 9 | 56.75 years STANDARD_DEVIATION 13.4 | 63 years STANDARD_DEVIATION 10 | 58.75 years STANDARD_DEVIATION 9.43 | 58.5 years STANDARD_DEVIATION 7.33 | 59.25 years STANDARD_DEVIATION 9.063 |
| Region of Enrollment United States | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 36 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 36 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 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 | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 2 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG
Single Ascending Dose (SAD): Adverse events, concomitant medications: Days 1, 2, 3, 5, 8 Vital signs, Physical exams: Days 1, 2, 8 Complete blood counts (CBC), Serum chemistry, Liver function tests, Pharmacokinetics: Days 1, 2, 8 Lipids, Coagulation, Urinalysis, Pregnancy test: Days 1, 8 EKG, chest x-ray (CXR): Days 1 and 8 Multiple Ascending Dose (MAD): Adverse events, concomitant medications: Days 1, 2, 3, 4, 5, 8, 15, 29 Vital signs, Physical exams: Days 1, 2, 3, 4, 5, 8, 15, 29 CBC, Serum chemistry, Liver function tests, Pharmacokinetics: Days 1, 3, 5, 8, 15, 29 Lipids, Coagulation, Urinalysis, Pregnancy test, EKG: Days 1, 5, 29 CXR: Days 1, 29
Time frame: 29 Day
Population: All patients participating in each arm were assessed for adverse events by symptoms, physical examination and laboratory studies.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Reproductive Grade 2,3, or 4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Skin Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Blood Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Reproductive Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Liver Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Blood Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Reproductive Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Liver Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Blood Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Skin Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Skin Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Liver Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Skin Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Blood Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Skin Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Reproductive Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Liver Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Blood Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Liver Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Skin Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Blood Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Reproductive Grade 2,3, or 4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Reproductive Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Liver Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Reproductive Grade 2,3, or 4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Liver Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Skin Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Liver Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Blood Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Reproductive Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Liver Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Blood Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Blood Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Skin Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Reproductive Grade 2,3,4 Adverse Events | 0 Participants |
| SAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Skin Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Reproductive Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Liver Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Skin Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Blood Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Skin Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Reproductive Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Liver Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Blood Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Skin Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Reproductive Grade 2,3, or 4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Liver Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.1 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Blood Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Reproductive Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Liver Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Liver Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Skin Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Blood Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Reproductive Grade 2,3, or 4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Skin Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Blood Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Skin Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Liver Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Blood Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Reproductive Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 0.5 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Skin Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Reproductive Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Liver Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Skin Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Reproductive Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Reproductive Grade 2,3, or 4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Blood Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Liver Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Respiratory Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Liver Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Urinary Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Digestive Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Skin Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Blood Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Lab: Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Endocrine Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | Nervous Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Cardiovascular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Muscular Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Blood Grade 2,3,4 Adverse Events | 0 Participants |
| MAD sPIF 1.0 | Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG | PE Skeletal Grade 2,3,4 Adverse Events | 0 Participants |
Secondary
Number of Participants With Anti-sPIF Antibodies and Drug Interactions
Following sPIF administration, using a validated assay, serum samples were tested for anti-sPIF antibodies
Time frame: 29 Day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SAD sPIF 0.1 | Number of Participants With Anti-sPIF Antibodies and Drug Interactions | Number of Patients with anti-sPIF Antibody | 0 participants |
| SAD sPIF 0.1 | Number of Participants With Anti-sPIF Antibodies and Drug Interactions | Number of Patients with Drug to Drug Interactions | 0 participants |
| SAD sPIF 0.5 | Number of Participants With Anti-sPIF Antibodies and Drug Interactions | Number of Patients with anti-sPIF Antibody | 0 participants |
| SAD sPIF 0.5 | Number of Participants With Anti-sPIF Antibodies and Drug Interactions | Number of Patients with Drug to Drug Interactions | 0 participants |
| SAD sPIF 1.0 | Number of Participants With Anti-sPIF Antibodies and Drug Interactions | Number of Patients with anti-sPIF Antibody | 0 participants |
| SAD sPIF 1.0 | Number of Participants With Anti-sPIF Antibodies and Drug Interactions | Number of Patients with Drug to Drug Interactions | 0 participants |
| MAD sPIF 0.1 | Number of Participants With Anti-sPIF Antibodies and Drug Interactions | Number of Patients with anti-sPIF Antibody | 0 participants |
| MAD sPIF 0.1 | Number of Participants With Anti-sPIF Antibodies and Drug Interactions | Number of Patients with Drug to Drug Interactions | 0 participants |
| MAD sPIF 0.5 | Number of Participants With Anti-sPIF Antibodies and Drug Interactions | Number of Patients with anti-sPIF Antibody | 0 participants |
| MAD sPIF 0.5 | Number of Participants With Anti-sPIF Antibodies and Drug Interactions | Number of Patients with Drug to Drug Interactions | 0 participants |
| MAD sPIF 1.0 | Number of Participants With Anti-sPIF Antibodies and Drug Interactions | Number of Patients with anti-sPIF Antibody | 0 participants |
| MAD sPIF 1.0 | Number of Participants With Anti-sPIF Antibodies and Drug Interactions | Number of Patients with Drug to Drug Interactions | 0 participants |