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

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

Official Title
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A Phase 1, Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Aldafermin in Healthy Adult Male Japanese and Non-Japanese Subjects

Conditions
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Healthy Male

Intervention / Treatment
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* Biological: Aldafermin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aldafermin 0.3mg<br>Subcutaneous injection of a single dose of aldafermin 0.3mg in healthy adult male Japanese or non-Japanese subjects | Biological: Aldafermin<br>* Single dose of aldafermin<br>* Other names: NGM282;|
| Experimental: Aldafermin 1mg<br>Subcutaneous injection of a single dose of aldafermin 1mg in healthy adult male Japanese or non-Japanese subjects | Biological: Aldafermin<br>* Single dose of aldafermin<br>* Other names: NGM282;|
| Experimental: Aldafermin 3mg<br>Subcutaneous injection of a single dose of aldafermin 3mg in healthy adult male Japanese or non-Japanese subjects | Biological: Aldafermin<br>* Single dose of aldafermin<br>* Other names: NGM282;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of a single dose aldafermin | Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4) | 4 days | 
| Area under the concentration-time curve of a single dose aldafermin | Area under the concentration-time curve from time zero extrapolated to infinity (AUC infinity) | 4 days | 
| Time to maximum concentration (Tmax) of a single dose aldafermin | Time to maximum concentration (Tmax) | 4 days | 
| Apparent terminal elimination half-life (T1/2) of a single dose aldafermin | Apparent terminal elimination half-life (T1/2) | 4 days | 
| Frequency of adverse events | Frequency of treatment-emergency adverse events (TEAE) and serious adverse events (SAEs) | 10 days | 
| Type of adverse events | Severity and duration of treatment-emergency adverse events (TEAE) and serious adverse events (SAEs) | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in concentration of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4) | Absolute change from baseline | 6 and 24 hours post dose | 
| Percent change of C4 | Percent change from baseline | 6 and 24 hours post dose |