Clinical Study of IBI362 in Healthy Chinese Male Subjects

Overweight/Obesity Clinical Trial

Official title:

Clinical Study to Evaluate the Pharmacokinetics and Safety of IBI362 Lyophilized Powder and IBI362 Liquid Formulation in Healthy Chinese Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04773977
• Other study ID #: CIBI362B102
• Status: Completed
• Phase: Phase 1
• Start date: March 3, 2021
• Est. completion date: June 17, 2021

Study information

• Verified date: March 2021
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Pharmacokinetic；Safety

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 17, 2021
• Est. primary completion date: March 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Overweight/Obesity

Intervention

Drug:
• IBI362 liquid formulation
Administered by subcutaneous injection
• IBI362 lyophilized powder
Administered by subcutaneous injection

Locations

Country	Name	City	State
China	The Sceond Affiliated Hospital of Nanchang University	Nanchang

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the PK parameters of IBI362 in healthy Chinese male subjects	Peak Plasma Concentration (Cmax)	From the first dose of study drug until 8 weeks
Primary	Evaluate the PK parameters of IBI362 in healthy Chinese male subjects	Area under the plasma concentration versus time curve (AUC)	From the first dose of study drug until 8 weeks
Secondary	Number of Participants With Adverse Events	The relationship of each adverse event to the investigational product was assessed by the investigator.	From the first dose of study drug until 8 weeks