Clinical Study of IBI362 in Healthy Chinese Male Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04773977

Enrollment

Registered

2021-02-26

Start date

2021-03-03

Completion date

2021-06-17

Last updated

2021-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight/Obesity

Keywords

Pharmacokinetic, Safety

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

Interventions

DRUGIBI362 liquid formulation

Administered by subcutaneous injection

DRUGIBI362 lyophilized powder

Administered by subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the PK parameters of IBI362 in healthy Chinese male subjects	From the first dose of study drug until 8 weeks	Peak Plasma Concentration (Cmax)

Secondary

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026