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

NCT04828265 | Completed Phase 1 FDA Drug

• 1 other identifier: 282-HV-105
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Male

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Absolute change in concentration of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4)

  6 and 24 hours post dose

• Percent change of C4

  6 and 24 hours post dose

Study Arms (3)

Aldafermin 0.3mg

EXPERIMENTAL

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

Biological: Aldafermin

Aldafermin 1mg

EXPERIMENTAL

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

Biological: Aldafermin

Aldafermin 3mg

EXPERIMENTAL

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

Biological: Aldafermin

Interventions

Aldafermin BIOLOGICAL

Single dose of aldafermin

Also known as: NGM282

Aldafermin 0.3mg; Aldafermin 1mg; Aldafermin 3mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NGM Biopharmaceuticals, Inc: lead

Study Sites (1)

NGM Clinical Study Site 112

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

aldafermin

Study Officials

• NGM Study Director

  NGM Biopharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 2, 2021
• Study Start: April 13, 2021
• Primary Completion: July 6, 2021
• Study Completion: July 6, 2021
• Last Updated: January 31, 2022

Record last verified: 2021-12

Locations

US (1)