NCT06778850已完成1 期
A Randomized, Double-blind, Placebo-controlled Phase I/IIa Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of MDR-001 Tablets Administrated Orally in Healthy Participants and Obese/ Overweight Participants
MindRank AI Ltd2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2023年6月9日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
To investigate the safety and tolerability after single and multiple ascending doses of MDR-001 Tablets administered orally in healthy participants and obese/ overweight participants.
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
- 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
- •Main inclusion criteria:
- •Participants who are aged ≥ 18 and ≤ 55 years at the time of signing the informed consent, no gender restriction.
- •Participants with body weight ≥ 50 kg for males, and ≥ 45 kg for females; 18 ≤ body mass index (BMI) < 25 kg/m2 for healthy participants, and 25 ≤ BMI ≤ 35 kg/m2 for obese/overweight participants.
- •For healthy participants, physical examination and vital signs must be normal, or abnormal but clinically insignificant. For obese/overweight participants, physical examination and vital signs must be normal, or abnormal but clinically insignificant, and the vital signs should be within following ranges: systolic blood pressure: 90-150 mmHg; diastolic blood pressure: 50-95 mmHg.
排除标准
- •Participants with any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers.
- •Participants with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or those with hereditary diseases that easily induce to medullary thyroid carcinoma.
- •Participants with a history of pancreatitis or symptomatic gallbladder disease.
- •Participants with serum calcitonin levels above the upper limit of normal (ULN) at screening.
- •Participants with significant changes in diet or exercise habits within 3 months prior to screening.
- •Participants with clinically significant electrocardiogram abnormality; or ECG QTcF values > 450 ms for males or > 470 ms for females.
- •Participants with clinically significant abnormalities in laboratory examinations (obese/overweight participants with triglycerides ≤ 5.7 mmol/L, total cholesterol ≤ 7.75 mmol/L, low-density lipoprotein cholesterol ≤ 4.9 mmol/L, and fasting blood glucose ≤ 7 mmol/L can be included); or those with clinically significant findings indicating the following diseases within 12 months prior to screening, including but not limited to disorders of respiratory system, circulatory system, digestive system, endocrine system, rheumatological/immune system, nervous system, and blood system, and mental/psychological disorders, which are considered by the investigator as inappropriate for participation in this study.
研究组 & 干预措施
MDR-001（SAD）
Experimental
Single doses of MDR-001 administered orally.
干预措施: MDR-001 (Drug)
Placebo (MAD)
Experimental
Placebo administered orally.
干预措施: palcebo (Drug)
MDR-001 (MAD)
Experimental
Multiple doses of MDR-001 administered orally.
干预措施: MDR-001 (Drug)
Placebo (SAD)
Experimental
Placebo administered orally.
干预措施: palcebo (Drug)
结局指标
主要结局
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Day 84
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- PK: Area Under the Concentration Versus Time Curve (AUC) of MDR-001(Baseline through Day 84)
- Change from Baseline in Fasting Glucose(Baseline through Day 84)
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of MDR-001(Baseline through Day 84)
- Change from Baseline in Glycated Hemoglobin (HbA1c)(Baseline through Day 84)
- Change from Baseline in Body Weight(Baseline through Day 84)
研究者
研究点 (2)
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