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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04773977
Other study ID # CIBI362B102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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