A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of IBI3042 in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This is a randomized, investigator- and participant-blinded, placebo-controlled, parallel-group, dose-escalation Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of single ascending oral doses of IBI3042, in healthy adult participants. Approximately 32 healthy participants will be enrolled across 4 single ascending dose groups, with 8 participants per group randomized in a 6:2 ratio to receive a single oral dose of IBI3042 or matching placebo. A sentinel-dosing design is used for the first dose cohort. Safety and PK data are assessed to support dose escalation decisions by the Safety Review Committee.
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, 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
- •Aged 18 to 55 years, inclusive.
- •BMI ≥20 and <32 kg/m² and body weight ≥50 kg;
- •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, or dietary supplement vitamins within 2 weeks or 5 half-lives, whichever is greater, prior to screening; or use of any herbal products within 4 weeks prior to screening.
- •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
Matching Placebo
Oral, matching to IBI3042, corresponding dose regimen according to study cohort
干预措施: Matching Placebo (Drug)
Investigational Drug: IBI3042
Oral, corresponding dose regimen according to study cohort
干预措施: Investigational Drug: IBI3042 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: through study completion, an average of 29 days
Number of Participants With Adverse Events.
Number of Participants With Clinically Significant Abnormal Vital Signs
时间窗: through study completion, an average of 29 days
Number of Participants With Clinically Significant Abnormal Vital Signs
Number of Participants With Clinically Significant Abnormal 12-lead electrocardiogram
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding on resting 12-lead electrocardiogram(ECG). Participants shall lie supine for at least 5 minutes prior to ECG acquisition and remain supine during ECGrecording. Evaluated ECG parameters include RR interval, PR interval, heart rate, QT interval, and QTcF(QTcF=QT/RR\^0.33).
Number of Participants With Abnormal General Appearance Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in general appearance on physical examination.
Number of Participants With Abnormal Respiratory Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in respiratory tract assessment on physical examination.
Number of Participants With Abnormal Cardiovascular Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in cardiovascular assessment on physical examination.
Number of Participants With Abnormal Abdominal Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in abdominal assessment on physical examination.
Number of Participants With Abnormal Skin Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in skin assessment on physical examination.
Number of Participants With Abnormal Head and Neck Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in head and neck (ear, eye, nose, throat) assessment on physical examination.
Number of Participants With Abnormal Lymph Node Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in lymph node assessment on physical examination.
Number of Participants With Abnormal Thyroid Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in thyroid assessment on physical examination.
Number of Participants With Abnormal Musculoskeletal Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in musculoskeletal (spine and extremities) assessment on physical examination.
Number of Participants With Abnormal Neurological Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in neurological assessment on physical examination.
Number of Participants With Abnormal Blood Routine Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in blood routine tests.
Number of Participants With Abnormal Blood Biochemistry Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in blood biochemistry tests, including blood lipids.
Number of Participants With Abnormal Coagulation Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in coagulation routine tests.
Number of Participants With Abnormal Urine Routine Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in urine routine tests.
Number of Participants With Abnormal Calcitonin Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in calcitonin test.
Number of Participants With Abnormal Glycated Hemoglobin Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in glycated hemoglobin (HbA1c) test.
Number of Participants With Abnormal Infection-Related Immunology Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in infection-related immunology tests.
Number of Participants With Abnormal Thyroid Function Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in thyroid function tests.
Number of Participants With Abnormal Pregnancy Test Findings
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in pregnancy test.
次要结局
- Area Under the Plasma Concentration Time Curve (AUC)(through study completion, an average of 29 days)
- Peak Plasma Concentration (Cmax)(through study completion, an average of 29 days)
- Time to Reach Peak Plasma Concentration (Tmax)(through study completion, an average of 29 days)
- Apparent Clearance (CL/F)(through study completion, an average of 29 days)
- Apparent Volume of Distribution (Vz/F)(through study completion, an average of 29 days)
- Terminal Half-Life (T1/2)(through study completion, an average of 29 days)