A First-in-human, Randomised, Double-masked (Sponsor Unmasked), Placebo-controlled, Parallel Group, Single Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of TGM-148 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Frequency and severity of 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-148 in healthy adults
详细描述
This trial is a Phase 1, FIH, randomised, double-masked (sponsor unmasked), placebo-controlled, parallel-group, single ascending dose trial designed to evaluate the safety, tolerability, PK, and PD of a single SC dose of TGM-148 in healthy participants.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 基础科学
- 盲法
- 双盲 (受试者、研究者)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- Healthy adults aged 18 to 45 years who are able to provide written informed consent.
- Medically suitable for study participation based on protocol-defined assessments.
- Body mass index (BMI) between 18.0-30.0 kg/m² (inclusive) and a body weight >50 kg.
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-148
Participants will receive study treatment according to the assigned intervention.
干预措施: TGM-148 (Drug)
Placebo
Participants will receive placebo according to the assigned intervention.
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency and severity of adverse events [Safety and tolerability]
时间窗: From start of study drug administration through 16 weeks after study drug administration.
次要结局
- Area under the plasma concentration-time curve (AUC) of TGM-148 (ng·h/mL)(From start of study drug administration through 48 hours after the last study drug administration.)
- Maximum observed plasma concentration (Cmax) of TGM-148 (ng/mL)(From start of study drug administration through 48 hours after study drug administration.)
- Time of maximum plasma concentration (Tmax) of TGM-148(From start of study drug administration through 48 hours after study drug administration.)
- Half life (T½) of TGM-148(From start of study drug administration through 48 hours after study drug administration.)
- Change from baseline in target biomarker levels in plasma(From start of study drug administration through 16 weeks after study drug administration.)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07843368
- 其他研究编号
- TGM-148-001
日期
- 首次提交
- (9天前)
- 首次发布
- (前天)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
Study results will be disseminated through publication