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Completed

NCT Number: NCT04773977

Clinical Study of IBI362 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.

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Key information

Conditions

Overweight/Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The Sceond Affiliated Hospital of Nanchang University

Nanchang, China

About this study

Pharmacokinetic；Safety

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IBI362 liquid formulation

Drug

Administered by subcutaneous injection

IBI362 lyophilized powder

Drug

Administered by subcutaneous injection

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2021
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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