Study of Aldafermin (NGM282) in Healthy Adult Male Japanese and Non-Japanese Subjects

Completed · Phase 1

Conditions studied: Healthy Male

In brief

This is an open-label study to assess safety, tolerability, and pharmacokinetics of Aldafermin (NGM282) in healthy adult male Japanese and non-Japanese subjects

Key facts

Study ID

NCT04828265

Run by

NGM Biopharmaceuticals, Inc

People needed

36

Starts

2021-04-13

Expected to finish

2021-07-06

Last updated by the study team

2022-01-31

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• NGM Clinical Study Site 112 — Cypress, California, United States

Full record on ClinicalTrials.gov

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