Status:
COMPLETED
Clinical Study of IBI362 in Healthy Chinese Male Subjects
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Overweight/Obesity
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief 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.
Detailed Description
Pharmacokinetic；Safety
Eligibility Criteria
Inclusion
- 20 years old≤ Healthy males≤45 years old
- 19 kilograms per meter squared (kg/m²)≤Body Mass Index≤26 kg/m²
- Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
Exclusion
- Subjects who have previously completed or discontinued from this study, or who have used IBI362.
- Abnormal vital signs and physical examination during the screening period;
- 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.
- Have a previous or current mental illness.
- A family history of medullary thyroid carcinoma or multiple endocrine tumor syndrome type 2.
- There are other factors judged by the investigators that are not suitable for inclusion in this study.
Key Trial Info
Start Date :
March 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04773977
Start Date
March 3 2021
End Date
June 17 2021
Last Update
July 8 2021
Active Locations (1)
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1
The Sceond Affiliated Hospital of Nanchang University
Nanchang, China