A Phase 1, Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Aldafermin in Healthy Adult Male Japanese and Non-Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Frequency of adverse events
研究概览
简要总结
This is an open-label study to assess safety, tolerability, and pharmacokinetics of Aldafermin (NGM282) in healthy adult male Japanese and non-Japanese subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Frequency of adverse events
时间窗: 10 days
Frequency of treatment-emergency adverse events (TEAE) and serious adverse events (SAEs)
Type of adverse events
时间窗: 10 days
Severity and duration of treatment-emergency adverse events (TEAE) and serious adverse events (SAEs)
Area under the concentration-time curve of a single dose aldafermin
时间窗: 4 days
Area under the concentration-time curve from time zero extrapolated to infinity (AUC infinity)
Time to maximum concentration (Tmax) of a single dose aldafermin
时间窗: 4 days
Time to maximum concentration (Tmax)
Apparent terminal elimination half-life (T1/2) of a single dose aldafermin
时间窗: 4 days
Apparent terminal elimination half-life (T1/2)
Maximum observed plasma concentration (Cmax) of a single dose aldafermin
时间窗: 4 days
Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)
次要结局
- Percent change of C4(6 and 24 hours post dose)
- Absolute change in concentration of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4)(6 and 24 hours post dose)