An Exploratory Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Dose IBI3042 in Healthy or Overweight Participants and Multiple-Dose IBI3042 in Overweight or Obese Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (Part A)
研究概览
简要总结
The goal of this study is to learn about the safety and tolerability of IBI3042, an investigational oral drug that activates the glucagon-like peptide-1 (GLP-1) receptor. The study will also assess how IBI3042 moves through the body and explore its effects on body weight and related measures. Researchers will evaluate whether single and multiple oral doses of IBI3042 can be administered with acceptable safety and tolerability.
The study has two parts. In Part A, healthy or overweight participants will receive a single oral dose of IBI3042 or placebo. In Part B, overweight or obese participants will receive multiple oral doses of IBI3042 or placebo over 29 days. Participants will be assigned to different dose groups, and dose escalation will be guided by safety, tolerability, and available drug concentration data from earlier groups.
Participants will undergo safety assessments and blood sampling during the study. These assessments will include medical examinations, vital signs, laboratory tests, and electrocardiograms. In Part B, researchers will also assess changes in body weight, body mass index, waist circumference, and other metabolic measures.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, care providers and outcome assessors are blinded to treatment assignment. Most investigators remain blinded. Selected unblinded investigators (dose-escalation committee members) have access to treatment allocation for safety evaluation and dose-escalation decision-making.
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
- •Aged 18 to 55 years, inclusive.
- •For Part A: BMI ≥20 and<28 kg/m^2 and body weight ≥50 kg.
- •For Part B: BMI ≥24 and ≤40 kg/m^2, with stable body weight during the 3 months prior to screening.
- •Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose.
- •Able and willing to comply with study procedures and voluntarily provide written informed consent.
排除标准
- •Known or suspected hypersensitivity to any component of the study drug or to GLP-1 receptor agonists.
- •History of diabetes or abnormal glycemic parameters at screening.
- •Personal or family history of thyroid C-cell carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2A or 2B), or calcitonin ≥20 ng/L at screening.
- •History of acute or chronic pancreatitis, or clinically significant pancreatic enzyme elevation at screening.
- •Use of medications that may significantly affect gastrointestinal motility, appetite, or drug absorption within 3 months prior to screening.
- •Clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that may increase study-related risk or interfere with study assessments.
- •Clinically significant abnormalities in physical examination or laboratory tests at screening.
- •History of malignancy within 5 years, except for basal cell or squamous cell skin cancer.
- •Use of prescription or over-the-counter medications, dietary supplements, or herbal medicines within 2 weeks or 5 half-lives prior to screening, except as permitted by the protocol.
- •Participation in another drug or medical device clinical study within 3 months prior to screening or within 5 half-lives of the investigational drug, as applicable.
- •Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the study.
研究组 & 干预措施
IBI3042 treatment Group
干预措施: IBI3042 (Drug)
Placebo Control Group
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (Part A)
时间窗: Through study completion, an average of 29 days.
Number of Participants With Abnormal Physical Examination Findings (Part A)
时间窗: Through study completion, an average of 29 days.
Number of Participants With Clinically Significant Abnormal Vital Signs (Part A)
时间窗: Through study completion, an average of 29 days.
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part A)
时间窗: Through study completion, an average of 29 days.
Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part A)
时间窗: Through study completion, an average of 29 days.
Number of Participants With Adverse Events (Part B)
时间窗: Through study completion, an average of 57 days.
Number of Participants With Abnormal Physical Examination Findings (Part B)
时间窗: Through study completion, an average of 57 days.
Number of Participants With Clinically Significant Abnormal Vital Signs (Part B)
时间窗: Through study completion, an average of 57 days.
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part B)
时间窗: Through study completion, an average of 57 days.
Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part B)
时间窗: Through study completion, an average of 57 days.
次要结局
- Area under the blood concentration-time curve (AUC) (Part A)(Through study completion, an average of 29 days.)
- Peak Plasma Concentration (Cmax) (Part A)(Through study completion, an average of 29 days.)
- Time to Reach Peak Plasma Concentration (Tmax) (Part A)(Through study completion, an average of 29 days.)
- Apparent Clearance (CL/F) (Part A)(Through study completion, an average of 29 days.)
- Apparent Volume of Distribution (Vz/F) (Part A)(Through study completion, an average of 29 days.)
- Terminal Half-Life (T1/2) (Part A)(Through study completion, an average of 29 days.)
- Area Under the Plasma Concentration-Time Curve (AUC) (Part B)(Through study completion, an average of 57 days.)
- Peak Plasma Concentration (Cmax) (Part B)(Through study completion, an average of 57 days.)
- Time to Reach Peak Plasma Concentration (Tmax) (Part B)(Through study completion, an average of 57 days.)
- Apparent Clearance (CL/F) (Part B)(Through study completion, an average of 57 days.)
- Apparent Volume of Distribution (Vz/F) (Part B)(Through study completion, an average of 57 days.)
- Terminal Half-Life (T1/2) (Part B)(Through study completion, an average of 57 days.)
- Changes in body weight from baseline (Part B)(Through study completion, an average of 57 days.)
- Percentage change in body weight from baseline (Part B)(Through study completion, an average of 57 days.)
- Percentage change in waist circumference from baseline (Part B)(Through study completion, an average of 57 days.)
- Percentage change in body mass index (BMI) from baseline (Part B)(Through study completion, an average of 57 days.)
- Body Mass Index (BMI) change from baseline (Part B)(Through study completion, an average of 57 days.)
- Changes in waist circumference from baseline (Part B)(Through study completion, an average of 57 days.)
研究者
Hongwei Jiang
Chief Physician
Henan University of Science and Technology