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

NGM Biopharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Male

Treatments: Biological: Aldafermin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04828265

282-HV-105

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Aldafermin 0.3mg

Experimental group

Description:

Subcutaneous injection of a single dose of aldafermin 0.3mg in healthy adult male Japanese or non-Japanese subjects

Treatment:

Biological: Aldafermin

Aldafermin 1mg

Experimental group

Description:

Subcutaneous injection of a single dose of aldafermin 1mg in healthy adult male Japanese or non-Japanese subjects

Treatment:

Biological: Aldafermin

Aldafermin 3mg

Experimental group

Description:

Subcutaneous injection of a single dose of aldafermin 3mg in healthy adult male Japanese or non-Japanese subjects

Treatment:

Biological: Aldafermin