NCT07020949已完成1 期
Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of THDBH120 in Chinese Patients With T2DM: A Randomized, Bouble-Blind, Placebo-Controlled Phase Ib Trial
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s)
研究概览
简要总结
The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and efficacy of THDBH120 injection in participants with T2DM. This study includes three multiple-ascending dose cohorts.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 18 to 75 years of age, inclusive;
- •Have T2DM for at least 6 months before screening based on the disease diagnostic criteria (World Health Organization [WHO] Classification for Diabetes);
- •Treated with diet and exercise alone, or a stable dose of metformin (≥1000 mg/day and not more than the locally approved dose) for at least 2 months prior to screening;
- •Have a BMI between 23 and 35 kg/m²(inclusive) at screening;
- •HbA1c levels: 7.0% to 10.0% (inclusive) for subjects treated by diet or exercise alone; 7.0% to 9.0% (inclusive) for subjects receiving stable-dose metformin.
排除标准
- •Have been diagnosed with proliferative diabetic retinopathy, diabetic maculopathy, or non-proliferative diabetic retinopathy requiring treatment during the study;
- •Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia type 2;
- •Have diagnosed hyperthyroidism or hypothyroidism;
- •Have grade 2 hypoglycemia events or grade 3 hypoglycemia events within 6 months prior to screening;
- •Have a history of ketoacidosis, lactic acidosis, or hyperosmolar state leading to hospitalization within 6 months prior to screening;
- •Presence of uncontrolled hypertension at screening: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg;
- •Prolonged QTcF interval on 12-lead ECG at screening (QTcF≥450 ms for males, >470 ms for females), PR interval >200 ms, or the presence of long QT syndrome, second- or third-degree atrioventricular block, left or right bundle branch block, Wolff-Parkinson-White syndrome, or any other clinically significant arrhythmias (except sinus arrhythmia);
- •Weight change ≥ 5% within 3 months prior to screening;
- •Have been treated with insulin, excluding insulin therapy for gestational diabetes mellitus, or acute/temporary insulin therapy (≤ 14 days) for conditions such as acute illness, hospitalization, or elective surgery.
研究组 & 干预措施
THDBH120 injection
Experimental
干预措施: THDBH120 injection (Drug)
Placebo of THDBH120 injection
Placebo Comparator
干预措施: Placebo of THDBH120 injection (Drug)
结局指标
主要结局
Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s)
时间窗: 78 days
次要结局
- Number of Participants With Anti-THBHD120 Antibodies(78 days)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of THDBH120.(Day 1 Pre-dose through Day 43)
- Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of THDBH120(Day 1 Pre-dose through Day 43)
- Change From Baseline in HbA1C(43 days)
研究者
研究点 (1)
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