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

Launched by NGM BIOPHARMACEUTICALS, INC · Mar 31, 2021

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility criteria

• 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.