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

Healthy Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04828265
• Other study ID #: 282-HV-105
• Status: Completed
• Phase: Phase 1
• Start date: April 13, 2021
• Est. completion date: July 6, 2021

Study information

• Verified date: December 2021
• Source: NGM Biopharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 6, 2021
• Est. primary completion date: July 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Male

Intervention

Biological:
• Aldafermin
Single dose of aldafermin

Locations

Country	Name	City	State
United States	NGM Clinical Study Site 112	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
NGM Biopharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of a single dose aldafermin	Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)	4 days
Primary	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
Primary	Time to maximum concentration (Tmax) of a single dose aldafermin	Time to maximum concentration (Tmax)	4 days
Primary	Apparent terminal elimination half-life (T1/2) of a single dose aldafermin	Apparent terminal elimination half-life (T1/2)	4 days
Primary	Frequency of adverse events	Frequency of treatment-emergency adverse events (TEAE) and serious adverse events (SAEs)	10 days
Primary	Type of adverse events	Severity and duration of treatment-emergency adverse events (TEAE) and serious adverse events (SAEs)	10 days
Secondary	Absolute change in concentration of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4)	Absolute change from baseline	6 and 24 hours post dose
Secondary	Percent change of C4	Percent change from baseline	6 and 24 hours post dose