RESTORE-MASH: A Phase 1/2 Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of TGM-312-SC01 in Healthy Participants and Adults With MASH
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Incidence and severity of treatment-emergent adverse events [Safety and tolerability]
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single ascending doses of TGM-312-SC01 in healthy adults and multiple ascending doses in patients with metabolic dysfunction-associated steatohepatitis (MASH).
详细描述
This is a Phase 1/2, randomised, masked, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of TGM-312-SC01 administered by subcutaneous injection. The study includes a single ascending dose component in healthy participants and a multiple ascending dose component in adults with metabolic dysfunction-associated steatohepatitis, with an optional expansion phase.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 70 years who are able to provide written informed consent.
- •Medically suitable for study participation based on protocol-defined assessments.
- •For the disease cohort, participants with clinical features consistent with metabolic dysfunction-associated steatohepatitis, as defined in the protocol.
排除标准
- •Clinically significant medical conditions, laboratory abnormalities, or other findings that, in the opinion of the investigator, could increase risk, interfere with study participation, or confound interpretation of study results.
- •Recent participation in another investigational study.
- •Use of medications that are prohibited by the protocol.
- •Any other condition that would make the individual unsuitable for study participation as determined by the investigator.
研究组 & 干预措施
TGM-312-SC01
Participants will receive study treatment according to the assigned intervention.
干预措施: TGM-312-SC01 (Drug)
Placebo
Participants will receive study treatment according to the assigned intervention.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events [Safety and tolerability]
时间窗: From start of study drug administration through 16 weeks after the last study drug administration.
次要结局
- Maximum observed plasma concentration (Cmax) of TGM-312-SC01 (ng/mL)(From start of study drug administration through 48 hours after the last study drug administration.)
- Area under the plasma concentration-time curve (AUC) of TGM-312-SC01 (ng·h/mL)(From start of study drug administration through 48 hours after the last study drug administration.)
- Change from baseline in target gene mRNA expression levels in tissue homogenate(From start of study drug administration through 16 weeks after the last study drug administration.)
- Change from baseline in target protein levels in tissue homogenate(From start of study drug administration through 16 weeks after the last study drug administration.)