Clinical Study of IBI362 in Healthy Chinese Male Subjects

• Status: Completed
• Trial end date: 2021-06-17
• Target enrollment: 0
• Participant gender: Male

Summary

This is a study to evaluate the pharmacokinetic characteristics and safety of IBI362 lyophilized powder and IBI362 liquid formulation in healthy Chinese male subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Criteria

Inclusion Criteria:

1. 20 years old≤ Healthy males≤45 years old

2. 19 kilograms per meter squared (kg/m²)≤Body Mass Index≤26 kg/m²

3. Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff

Exclusion Criteria:

1. Subjects who have previously completed or discontinued from this study, or who have used IBI362.

2. Abnormal vital signs and physical examination during the screening period;

3. Having cardiovascular, respiratory, liver, kidney, digestive, endocrine, hematologic, neurological, or muscle degenerative diseases can significantly affect drug absorption, metabolism, or elimination, or participation in the study increases risk or interferes with data interpretation.

4. Have a previous or current mental illness.

5. A family history of medullary thyroid carcinoma or multiple endocrine tumor syndrome type 2.

6. There are other factors judged by the investigators that are not suitable for inclusion in this study.