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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Male
• Intervention / Treatment: Biological: Aldafermin

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • NGM Clinical Study Site 112

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NGM Biopharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2021
• Primary Completion (Actual): July 6, 2021
• Study Completion (Actual): July 6, 2021

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 15, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 282-HV-105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No