A Phase 1 Randomised, Double-blind, Placebo-controlled Single Ascending and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYNT-101 in Healthy Adults and Healthy Adults Who Are Overweight or Have Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Safety Evaluation
研究概览
简要总结
A Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacodynamics of single and multiple dose regimens of SYNT-101 in healthy and overweight adults.
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
- Double (Participant, Investigator)
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
- •Must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
- •Adult males and females, 18 to 55 years of age (inclusive) at screening.
- •Medically healthy (in the opinion of the PI or delegate), as determined by pre-study medical history, and without clinically significant (CS) abnormalities.
- •Have suitable venous access for blood sampling.
- •Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
排除标准
- •Known hypersensitivity to the study drug or any of the study drug ingredients.
- •History of anaphylaxis or other significant allergy which, in the opinion of the PI (or delegate), would interfere with the volunteer's ability to participate in the study.
- •History or presence of CS cardiovascular, pulmonary, hepatic, renal, haematological, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months determined by the PI (or delegate) to be clinically relevant.
研究组 & 干预措施
Active Drug SYNT101
干预措施: SYNT101 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety Evaluation
时间窗: From enrolment up to 7 days post dosing in the SAD, up to 36 days post dosing in the MAD.
The Number of participants with Adverse Events, with abnormal Vital Signs, abnormal Physical Examination findings, abnormal Laboratory Tests results, abnormal 12-lead Electrocardiogram (ECG) readings.
Safety Evaluation
时间窗: From enrolment up to 7 days post dosing in the SAD and up to 36 days post dosing in the MAD.
The Number of participants with Adverse Events, with abnormal Vital Signs, abnormal Physical Examination findings, abnormal Laboratory Tests results, abnormal 12-lead Electrocardiogram (ECG) readings.
次要结局
- Area under the plasma concentration versus time curve (AUC) after single SYNT101 dose(At Pre-dose, 1 hr , 3 hr, 4 hr, 8 hr, 12 hr, 24 hours post-dose.)
- Area under the plasma concentration versus time curve (AUC) after multiple SYNT101 doses.(At Pre-Dose, 1 hr , 3 hr, 4 hr, 8 hr, 12 hr, 24 hours post-dose.)