Clinical trial NCT04828265: Study of Aldafermin (NGM282) in Healthy Adult Male Japanese and Non-Japanese Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2021-04-02
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of a single dose aldafermin
timeFrame: 4 days
measure: Area under the concentration-time curve of a single dose aldafermin
timeFrame: 4 days
measure: Time to maximum concentration (Tmax) of a single dose aldafermin
timeFrame: 4 days
measure: Apparent terminal elimination half-life (T1/2) of a single dose aldafermin
timeFrame: 4 days
measure: Frequency of adverse events
timeFrame: 10 days
measure: Type of adverse events
timeFrame: 10 days
Secondary outcomes:
measure: Absolute change in concentration of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4)
timeFrame: 6 and 24 hours post dose
measure: Percent change of C4
timeFrame: 6 and 24 hours post dose
Other outcomes:
Locations:
city: Cypress
country: United States
facility: NGM Clinical Study Site 112
state: California
Study officials:
affiliation: NGM Biopharmaceuticals, Inc
name: NGM Study Director
role: STUDY_DIRECTOR
References: