Clinical Study of IBI362 in Healthy Chinese Male Subjects

Innovent Biologics

Status and phase

Completed

Phase 1

Conditions

Overweight/Obesity

Treatments

Drug: IBI362 lyophilized powder

Drug: IBI362 liquid formulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT04773977

CIBI362B102

Details and patient eligibility

About

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

Full description

Pharmacokinetic；Safety

Enrollment

24 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.