A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of IBI3042 in Healthy Adult Participants

Registration

Registration

NCT07842393

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

TRIPLE

Status

NOT_YET_RECRUITING

Enrollment

32

Start

2026-09-29

Primary completion

2027-02-03

Lead sponsor

Fortvita Biologics (USA)Inc.

Conditions

Healthy Volunteers (HV)

Interventions

DRUG:Investigational Drug: IBI3042; DRUG:Matching Placebo

Results posted

FALSE

Registered primary outcomes

• Number of Participants With Adverse Events [through study completion, an average of 29 days]
• Number of Participants With Clinically Significant Abnormal Vital Signs [through study completion, an average of 29 days]
• Number of Participants With Clinically Significant Abnormal 12-lead electrocardiogram [through study completion, an average of 29 days]
• Number of Participants With Abnormal General Appearance Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Respiratory Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Cardiovascular Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Abdominal Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Skin Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Head and Neck Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Lymph Node Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Thyroid Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Musculoskeletal Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Neurological Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Blood Routine Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Blood Biochemistry Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Coagulation Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Urine Routine Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Calcitonin Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Glycated Hemoglobin Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Infection-Related Immunology Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Thyroid Function Findings [through study completion, an average of 29 days]
• Number of Participants With Abnormal Pregnancy Test Findings [through study completion, an average of 29 days]