Clinical Study of IBI362 in Healthy Chinese Male Subjects

Phase 1

Completed

• Conditions: Overweight/Obesity
• Interventions: Drug: IBI362 lyophilized powder; Drug: IBI362 liquid formulation

• Registration Number: NCT04773977
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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

Study Timeline

• Study First Submitted: 2021-02-21
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-02-26
• Status Verified: 2021-03
• Study Start: 2021-03-03
• Primary Completion: 2021-03-09
• Study Completion: 2021-06-17
• Last Update Submitted: 2021-07-07
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBI362 lyophilized powder	IBI362 lyophilized powder	Participants received single subcutaneous injection of IBI362 lyophilized powder
IBI362 liquid formulation	IBI362 liquid formulation	Participants received single subcutaneous injection of IBI362 liquid formulation

Primary Outcome Measures

Name	Time	Method
Evaluate the PK parameters of IBI362 in healthy Chinese male subjects	From the first dose of study drug until 8 weeks	Area under the plasma concentration versus time curve (AUC)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	From the first dose of study drug until 8 weeks	The relationship of each adverse event to the investigational product was assessed by the investigator.

Trial Locations

Locations (1)

The Sceond Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, China