Status:
COMPLETED
Study of Aldafermin (NGM282) in Healthy Adult Male Japanese and Non-Japanese Subjects
Lead Sponsor:
NGM Biopharmaceuticals, Inc
Conditions:
Healthy Male
Eligibility:
MALE
18-65 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- Male subjects between 18 and 65 years, inclusive, of age who are able to comprehend and willing to sign an informed consent form (ICF).
- Body mass index (BMI) range 18-35 kg/m2 (inclusive) at screening.
- Healthy subjects with no clinically significant medical history or findings on screening evaluation.
- 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.
- Subjects with a female partner of childbearing potential must agree to consistent and adequate birth control.
Exclusion
- Clinically significant cardiovascular or cerebrovascular event or new diagnosis within 6 months of screening.
- 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).
- History of malignancy, except resected, localized basal cell carcinoma, and squamous cell carcinoma.
- Abnormal, clinically significant electrocardiogram findings, in the opinion of the investigator.
- Abnormal, clinically significant liver function laboratory test results at screening as determined by the investigator.
- Calculated creatinine clearance (Cockcroft-Gault) \< 90 mL/min at screening.
- 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.
- 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.
- 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.
Key Trial Info
Start Date :
April 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04828265
Start Date
April 13 2021
End Date
July 6 2021
Last Update
January 31 2022
Active Locations (1)
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1
NGM Clinical Study Site 112
Cypress, California, United States, 90630