Study of Aldafermin (NGM282) in Healthy Adult Male Japane... | NCT04828265

NCT04828265

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Aldafermin	Biological	Single dose of aldafermin	Aldafermin 0.3mg Aldafermin 1mg Aldafermin 3mg

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.