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

Phase 1

Completed

• Conditions: Healthy Male
• Interventions: Biological: Aldafermin

• Registration Number: NCT04828265
• Lead Sponsor: NGM Biopharmaceuticals, Inc

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-02
• Study Start: 2021-04-13
• Primary Completion: 2021-07-06
• Study Completion: 2021-07-06
• Status Verified: 2021-12
• Last Update Submitted: 2022-01-15
• Last Update Posted: 2022-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aldafermin 1mg	Aldafermin	Subcutaneous injection of a single dose of aldafermin 1mg in healthy adult male Japanese or non-Japanese subjects
Aldafermin 3mg	Aldafermin	Subcutaneous injection of a single dose of aldafermin 3mg in healthy adult male Japanese or non-Japanese subjects
Aldafermin 0.3mg	Aldafermin	Subcutaneous injection of a single dose of aldafermin 0.3mg in healthy adult male Japanese or non-Japanese subjects

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Absolute change in concentration of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4)	6 and 24 hours post dose	Absolute change from baseline
Percent change of C4	6 and 24 hours post dose	Percent change from baseline

Trial Locations

Locations (1)

NGM Clinical Study Site 112; 🇺🇸 Cypress, California, United States