A Phase 1, First-in-Human, Double-blind, Placebo-controlled, Single-and Multiple-Ascending Oral Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of GM-60106 in Healthy Adults and Otherwise Healthy Adults With an Increased Body Mass Index and Markers of Non-Alcoholic Fatty Liver Disease
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To assess safety and tolerability of GM-60106 through incidence, nature, and severity of adverse events (AEs)
研究概览
简要总结
This is a Phase 1a/1b, randomised, double-blind, placebo-controlled single- and multiple-ascending dose study to evaluate the safety, tolerability, PK, and PD of GM-60106 in healthy adult male and female participants and otherwise healthy adults who have an increased BMI and markers of NAFLD.
详细描述
The study consists of 3 parts:
Part A (Single Ascending Dose [SAD]): Approximately 56 healthy participants will be enrolled into 7 cohorts and randomised to receive either GM-60106 or matching placebo at a ratio of 6:2 (GM-60106: placebo).
Part B (Multiple Ascending Dose [MAD]): Approximately 24 healthy participants will be enrolled into 3 cohorts and randomised to receive either GM-60106 or matching placebo at a ratio of 6:2 (GM-60106: placebo).
Part C (Multiple Ascending Dose [MAD]): Approximately 16 participants will be enrolled into 2 cohorts and randomised to receive either GM-60106 or matching placebo at a ratio of 6:2 (GM-60106: placebo). Cohorts will include otherwise healthy participants who have an increased BMI and markers of NAFLD.
Part B and Part C will occur only after the Safety Monitoring Committee (SMC) has reviewed all blinded safety data as well as any available PK and PD data from MAD cohorts that have completed the assessment of doses equal to the proposed starting Part C (MAD) dose and a dose higher (including a minimum safety review interval of 10 days after dosing the sixth participant in the cohort) and recommends initiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A (GM-60106)
Drug: GM-60106 Dosage: Part A: 2.5, 5, 10, 20, 40, 60, or 100 mg, Part B: 5, 10, 20 mg, Part C: 10, 20 mg Dosage Form: Bovine-gelatin capsules Route of Administration: Oral
干预措施: GM-60106 (Drug)
B (Placebo)
Dosage Form: Bovine-gelatin capsules Route of Administration: Oral Matching placebo has an identical formulation to the GM-60106 drug product, prepared without the active pharmaceutical ingredient
干预措施: Placebo (Other)
结局指标
主要结局
To assess safety and tolerability of GM-60106 through incidence, nature, and severity of adverse events (AEs)
时间窗: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
次要结局
- The pharmacokinetics (PK) of GM-60106. Plasma sample will be collected for PK assessment. Parameter: maximum concentration (Cmax)(Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days)
- The pharmacokinetics (PK) of GM-60106. Plasma sample will be collected for PK assessment. Parameter: time to maximum concentration (Tmax)(Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days)
- The pharmacokinetics (PK) of GM-60106. Urine sample will be collected for PK assessment. Parameter: Cumulative amount of drug excreted in urine (Ae)(Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days)
- The pharmacokinetics (PK) of GM-60106. Plasma sample will be collected for PK assessment. Parameter: Area under the curve (AUC) from time 0 to the last measurable concentration (AUC0-last)(Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days)
- The pharmacokinetics (PK) of GM-60106. Urine sample will be collected for PK assessment. Parameter: Renal clearance (CLr).(Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days)
- The pharmacodynamics (PD) of GM-60106 through liver function test (aspartate aminotransferase [AST])(Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days)
- The pharmacodynamics (PD) of GM-60106 through liver function test (alanine aminotransferase [ALT])(Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days)