Clinical Study of IBI362 in Healthy Chinese Male Subjects

July 7, 2021 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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

This is a study to evaluate the pharmacokinetic characteristics and safety of IBI362 lyophilized powder and IBI362 liquid formulation in healthy Chinese male subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pharmacokinetic；Safety

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Nanchang, China
        • The Sceond Affiliated Hospital of Nanchang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IBI362 liquid formulation
Participants received single subcutaneous injection of IBI362 liquid formulation
Drug: IBI362 liquid formulation
Administered by subcutaneous injection
EXPERIMENTAL: IBI362 lyophilized powder
Participants received single subcutaneous injection of IBI362 lyophilized powder
Drug: IBI362 lyophilized powder
Administered by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the PK parameters of IBI362 in healthy Chinese male subjects
Time Frame: From the first dose of study drug until 8 weeks
Peak Plasma Concentration (Cmax)
From the first dose of study drug until 8 weeks
Evaluate the PK parameters of IBI362 in healthy Chinese male subjects
Time Frame: From the first dose of study drug until 8 weeks
Area under the plasma concentration versus time curve (AUC)
From the first dose of study drug until 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: 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.
From the first dose of study drug until 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Investigators

  • Principal Investigator: Jian Li, The Sceond Affiliated Hospital of Nanchang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 3, 2021

Primary Completion (ACTUAL)

March 9, 2021

Study Completion (ACTUAL)

June 17, 2021

Study Registration Dates

First Submitted

February 21, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (ACTUAL)

February 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 7, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI362B102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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