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NCT07670897Not yet recruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 26 Jun 2026

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
64 (estimated)
First submitted
22 Jun 2026
Start date
1 Jul 2026
Primary completion date
29 Jul 2026
Lead sponsor
Gan & Lee Pharmaceuticals.
NCT number
NCT07670897

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 64
  • From 1 Jul 2026 to the primary completion date, 29 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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.
    • 2\. 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.
    • 3\. Have special dietary requirements and are unable to comply with the standardized diet.
    • 4\. Have a history of needle phobia or blood phobia, have difficulty in blood collection, or cannot tolerate venous puncture for blood sampling.
    • 5\. 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.

Who the study is looking for

  • 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.
    • 2\. 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.
    • 4\. 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.

Age in the registry: 18 years to 50 years · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Gan & Lee Pharmaceuticals Shandong Co., Ltd.,
Coordinator of this site? Confirm its status
LinyiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.