NCT07842393 - A Study of IBI3042 in Healthy Adult Participants | Crick | Crick

NCT07842393 - A Study of IBI3042 in Healthy Adult Participants | Crick | Crick

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Number of Participants With Adverse Events

Number of Participants With Adverse Events.

Time frame: through study completion, an average of 29 days

Number of Participants With Clinically Significant Abnormal Vital Signs

Number of Participants With Clinically Significant Abnormal Vital Signs

Time frame: through study completion, an average of 29 days

Number of Participants With Clinically Significant Abnormal 12-lead electrocardiogram

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).

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal General Appearance Findings

Number of participants with at least one clinically significant abnormal finding in general appearance on physical examination.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Respiratory Findings

Number of participants with at least one clinically significant abnormal finding in respiratory tract assessment on physical examination.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Cardiovascular Findings

Number of participants with at least one clinically significant abnormal finding in cardiovascular assessment on physical examination.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Abdominal Findings

Number of participants with at least one clinically significant abnormal finding in abdominal assessment on physical examination.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Skin Findings

Number of participants with at least one clinically significant abnormal finding in skin assessment on physical examination.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Head and Neck Findings

Number of participants with at least one clinically significant abnormal finding in head and neck (ear, eye, nose, throat) assessment on physical examination.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Lymph Node Findings

Number of participants with at least one clinically significant abnormal finding in lymph node assessment on physical examination.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Thyroid Findings

Number of participants with at least one clinically significant abnormal finding in thyroid assessment on physical examination.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Musculoskeletal Findings

Number of participants with at least one clinically significant abnormal finding in musculoskeletal (spine and extremities) assessment on physical examination.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Neurological Findings

Number of participants with at least one clinically significant abnormal finding in neurological assessment on physical examination.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Blood Routine Findings

Number of participants with at least one clinically significant abnormal finding in blood routine tests.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Blood Biochemistry Findings

Number of participants with at least one clinically significant abnormal finding in blood biochemistry tests, including blood lipids.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Coagulation Findings

Number of participants with at least one clinically significant abnormal finding in coagulation routine tests.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Urine Routine Findings

Number of participants with at least one clinically significant abnormal finding in urine routine tests.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Calcitonin Findings

Number of participants with at least one clinically significant abnormal finding in calcitonin test.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Glycated Hemoglobin Findings

Number of participants with at least one clinically significant abnormal finding in glycated hemoglobin (HbA1c) test.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Infection-Related Immunology Findings

Number of participants with at least one clinically significant abnormal finding in infection-related immunology tests.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Thyroid Function Findings

Number of participants with at least one clinically significant abnormal finding in thyroid function tests.

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Pregnancy Test Findings

Number of participants with at least one clinically significant abnormal finding in pregnancy test.

Time frame: through study completion, an average of 29 days

Secondary Outcomes

Area Under the Plasma Concentration Time Curve (AUC)

Time frame: through study completion, an average of 29 days

Peak Plasma Concentration (Cmax)

Time frame: through study completion, an average of 29 days

Time to Reach Peak Plasma Concentration (Tmax)

Time frame: through study completion, an average of 29 days

Apparent Clearance (CL/F)

Time frame: through study completion, an average of 29 days

Apparent Volume of Distribution (Vz/F)

Time frame: through study completion, an average of 29 days

Terminal Half-Life (T1/2)

Time frame: through study completion, an average of 29 days