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NCT Number: NCT07670897

Bioequivalence Study of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants

This study is a single-center, open-label, randomized, single-dose bioequivalence trial conducted in healthy adult participants.

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Key information

Conditions

T2D

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 1. Voluntarily sign the Informed Consent Form (ICF), be willing to accept subcutaneous injection, fully understand the study content, procedures and potential adverse reactions, and be able to comply with the contraindications and restrictions specified in this protocol.
  • Male, aged 18 to 50 years (inclusive) at the time of ICF signing. 3. Body weight ≥ 50 kg and body mass index (BMI) within the range of 18.5 to 24.0 kg/m² (inclusive) at screening.
  • Male participants of childbearing potential have no plans for conception, voluntarily adopt effective contraceptive measures, and have no sperm donation plans from the date of ICF signing until 4 weeks after dosing.

Exclusion criteria

  • 1. Have an allergic constitution, or a history of allergic diseases such as bronchial asthma and eczema (except for mild seasonal allergy); or have a history of severe food allergy (e.g., laryngeal edema, shock); or known allergy, hypersensitivity or intolerance to the investigational medicinal product (IMP) or similar products or their excipients; or have a clinically significant history of drug allergy or atopic allergic diseases.
  • Findings from physical examination, vital signs, routine laboratory tests, 12-lead electrocardiogram (ECG), chest imaging and other assessments at screening are judged to be clinically significant by the investigator.
  • Have special dietary requirements and are unable to comply with the standardized diet.
  • Have a history of needle phobia or blood phobia, have difficulty in blood collection, or cannot tolerate venous puncture for blood sampling.
  • The participant is an employee of the investigator or the study center, or a family member of an employee or the investigator; or the participant has other factors that, in the investigator's opinion, make him/her unsuitable for participation in the study.

Treatment and study plan

GZR4 injection A

Drug

GZR4 s.c., single-dose

GZR4 injection B

Drug

GZR4 s.c., single-dose

Primary outcomes

  1. Cmax

    Time frame: Day1-Day29

    Peak concentration following single administration of GZR4

  2. AUC₀-t

    Time frame: Day1-Day29

    Area under the plasma concentration-time curve from time zero to the last quantifiable sampling time point t after single administration of GZR4

  3. AUC₀-∞

    Time frame: Day1-Day29

    Area under the plasma concentration-time curve from time zero to infinity after single administration of GZR4

Secondary outcomes

  1. Tmax

    Time frame: Day1-Day29

  2. t1/2

    Time frame: Day1-Day29

  3. AUC_%Extrap

    Time frame: Day1-Day29

Study contacts

Contact information is provided by the study sponsor or research team.

Shiyun Lai

CONTACT

[email protected]

010-56456739

Yunda Zhuge

CONTACT

[email protected]

010-56456739

Sponsors and collaborators

Lead sponsor

Gan & Lee Pharmaceuticals.

Industry

Registry information

Official study title

A Randomized, Open-label, Single-dose Study to Evaluate the Bioequivalence of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

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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