Healthy Male
Conditions
Brief summary
This is an open-label study to assess safety, tolerability, and pharmacokinetics of Aldafermin (NGM282) in healthy adult male Japanese and non-Japanese subjects
Interventions
BIOLOGICALAldafermin
Single dose of aldafermin
Sponsors
NGM Biopharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male subjects between 18 and 65 years, inclusive, of age who are able to comprehend and willing to sign an informed consent form (ICF). 2. Body mass index (BMI) range 18-35 kg/m2 (inclusive) at screening. 3. Healthy subjects with no clinically significant medical history or findings on screening evaluation. 4. Clinical laboratory evaluations (e.g., fasted chemistry, complete blood count, urinalysis) within the reference range for the test laboratory at screening, unless deemed not clinically significant by the investigator. 5. Subjects with a female partner of childbearing potential must agree to consistent and adequate birth control.
Exclusion criteria
1. Clinically significant cardiovascular or cerebrovascular event or new diagnosis within 6 months of screening. 2. Clinically significant medical history or clinical manifestation of any significant metabolic, allergic, hepatic, renal, hematological, pulmonary, gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the investigator). 3. History of malignancy, except resected, localized basal cell carcinoma, and squamous cell carcinoma. 4. Abnormal, clinically significant electrocardiogram findings, in the opinion of the investigator. 5. Abnormal, clinically significant liver function laboratory test results at screening as determined by the investigator. 6. Calculated creatinine clearance (Cockcroft-Gault) \< 90 mL/min at screening. 7. Positive for hepatitis B surface antigen (HbsAg), human immunodeficiency antibodies (antiHIV), or hepatitis C virus antibodies (antiHCV) plus HCV-RNA. Subjects who are antiHCV positive, but HCV-RNA negative (secondary to treatment or viral clearance) are eligible with at least a 1-year period since documented sustained viral response at Week 12 post-treatment. 8. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to study entry. 9. Any acute or chronic condition that, in the opinion of the investigator, would limit the subject's ability to complete and/or participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Type of adverse events | 10 days | Severity and duration of treatment-emergency adverse events (TEAE) and serious adverse events (SAEs) |
| Apparent terminal elimination half-life (T1/2) of a single dose aldafermin | 4 days | Apparent terminal elimination half-life (T1/2) |
| Frequency of adverse events | 10 days | Frequency of treatment-emergency adverse events (TEAE) and serious adverse events (SAEs) |
| Maximum observed plasma concentration (Cmax) of a single dose aldafermin | 4 days | Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4) |
| Area under the concentration-time curve of a single dose aldafermin | 4 days | Area under the concentration-time curve from time zero extrapolated to infinity (AUC infinity) |
| Time to maximum concentration (Tmax) of a single dose aldafermin | 4 days | Time to maximum concentration (Tmax) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change of C4 | 6 and 24 hours post dose | Percent change from baseline |
| Absolute change in concentration of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4) | 6 and 24 hours post dose | Absolute change from baseline |
Countries
United States
Outcome results
None listed