Clinical Study of IBI362 in Healthy Chinese Male Subjects

NCT ID: NCT04773977

Last Updated: 2021-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2021-06-17

Brief Summary

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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

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Pharmacokinetic;Safety

Conditions

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Overweight/Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IBI362 liquid formulation

Participants received single subcutaneous injection of IBI362 liquid formulation

Group Type EXPERIMENTAL

IBI362 liquid formulation

Intervention Type DRUG

Administered by subcutaneous injection

IBI362 lyophilized powder

Participants received single subcutaneous injection of IBI362 lyophilized powder

Group Type EXPERIMENTAL

IBI362 lyophilized powder

Intervention Type DRUG

Administered by subcutaneous injection

Interventions

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IBI362 liquid formulation

Administered by subcutaneous injection

Intervention Type DRUG

IBI362 lyophilized powder

Administered by subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jian Li

Role: PRINCIPAL_INVESTIGATOR

The Sceond Affiliated Hospital of Nanchang University

Locations

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The Sceond Affiliated Hospital of Nanchang University

Nanchang, , China

Site Status

Countries

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China

Other Identifiers

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CIBI362B102

Identifier Type: -

Identifier Source: org_study_id

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