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Clinical Study of IBI362 in Healthy Chinese Male Subjects

Primary Purpose

Overweight/Obesity

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

IBI362 liquid formulation

IBI362 lyophilized powder

About this trial

This is an interventional treatment trial for Overweight/Obesity focused on measuring Pharmacokinetic, Safety

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts 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.

Sites / Locations

The Sceond Affiliated Hospital of Nanchang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

IBI362 liquid formulation

IBI362 lyophilized powder

Arm Description

Participants received single subcutaneous injection of IBI362 liquid formulation

Participants received single subcutaneous injection of IBI362 lyophilized powder

Outcomes

Primary Outcome Measures

Evaluate the PK parameters of IBI362 in healthy Chinese male subjects

Peak Plasma Concentration (Cmax)

Evaluate the PK parameters of IBI362 in healthy Chinese male subjects

Area under the plasma concentration versus time curve (AUC)

Secondary Outcome Measures

Number of Participants With Adverse Events

The relationship of each adverse event to the investigational product was assessed by the investigator.

Full Information

NCT ID

NCT04773977

First Posted

February 21, 2021

Last Updated

July 7, 2021

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04773977

Brief Title

Clinical Study of IBI362 in Healthy Chinese Male Subjects

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

March 3, 2021 (Actual)

Primary Completion Date

March 9, 2021 (Actual)

Study Completion Date

June 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight/Obesity

Keywords

Pharmacokinetic, Safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IBI362 liquid formulation

Arm Type

Experimental

Arm Description

Participants received single subcutaneous injection of IBI362 liquid formulation

Arm Title

IBI362 lyophilized powder

Arm Type

Experimental

Arm Description

Participants received single subcutaneous injection of IBI362 lyophilized powder

Intervention Type

Drug

Intervention Name(s)

IBI362 liquid formulation

Intervention Description

Administered by subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

IBI362 lyophilized powder

Intervention Description

Administered by subcutaneous injection

Primary Outcome Measure Information:

Title

Evaluate the PK parameters of IBI362 in healthy Chinese male subjects

Description

Peak Plasma Concentration (Cmax)

Time Frame

From the first dose of study drug until 8 weeks

Title

Evaluate the PK parameters of IBI362 in healthy Chinese male subjects

Description

Area under the plasma concentration versus time curve (AUC)

Time Frame

From the first dose of study drug until 8 weeks

Secondary Outcome Measure Information:

Title

Number of Participants With Adverse Events

Description

The relationship of each adverse event to the investigational product was assessed by the investigator.

Time Frame

From the first dose of study drug until 8 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian Li

Organizational Affiliation

The Sceond Affiliated Hospital of Nanchang University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Sceond Affiliated Hospital of Nanchang University

City

Nanchang

Country

China

12. IPD Sharing Statement

Learn more about this trial

Clinical Study of IBI362 in Healthy Chinese Male Subjects

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