T2DPhase 1NCT07670897
Bioequivalence Study of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants
A Phase 1 study testing GZR4 injection A and GZR4 injection B in people with T2D, run by Gan & Lee Pharmaceuticals. at 1 site in China.
Trial summary
This study is a single-center, open-label, randomized, single-dose bioequivalence trial conducted in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- T2D
- What is being tested?
- GZR4 injection A and GZR4 injection B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 29 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Gan & Lee Pharmaceuticals Shandong Co., Ltd.,
Linyi, Shandong, 276000
Yunda Zhuge, 010-56456739, zhugeyunda@ganlee.com
About this study
Official title: A Randomized, Open-label, Single-dose Study to Evaluate the Bioequivalence 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.
- Conditions
- T2D
- Being tested
- GZR4 injection A, GZR4 injection B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR4 injection ADrug
GZR4 s.c., single-dose
GZR4 injection BDrug
GZR4 s.c., single-dose
| Study group | Role | What they receive |
|---|---|---|
| GZR4 injection A | Experimental | Not described Receives: Drug: GZR4 injection A |
| GZR4 injection B | Experimental | Not described Receives: Drug: GZR4 injection B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak concentration following single administration of GZR4
Measured: Day1-Day29
AUC₀-t
Area under the plasma concentration-time curve from time zero to the last quantifiable sampling time point t after single administration of GZR4
Measured: Day1-Day29
AUC₀-∞
Area under the plasma concentration-time curve from time zero to infinity after single administration of GZR4
Measured: Day1-Day29
Secondary outcomes (3)
Tmax
Measured: Day1-Day29
t1/2
Measured: Day1-Day29
AUC_%Extrap
Measured: Day1-Day29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion29 Jul 2026 (estimated)
- Study completion29 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DStudies of the same condition, open and under way.
- More trials run by Gan & Lee Pharmaceuticals.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gan & Lee Pharmaceuticals.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670897
- Sponsor's protocol ID
- GZR4-T2D-106
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose Study to Evaluate the Bioequivalence of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07670897
- Acronym / sponsor ID
- GZR4-T2D-106
- Conditions
- T2D
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Gan & Lee Pharmaceuticals.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 29 Jul 2026 (estimated)
- Study completion
- 29 Jul 2026 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-center, open-label, randomized, single-dose bioequivalence trial conducted in healthy adult participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GZR4 injection A | Experimental | Drug: GZR4 injection A |
| GZR4 injection B | Experimental | Drug: GZR4 injection B |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GZR4 injection AGZR4 s.c., single-dose | Drug | GZR4 injection A |
| GZR4 injection BGZR4 s.c., single-dose | Drug | GZR4 injection B |
Primary outcome
Cmax
Time frame: Day1-Day29
Peak concentration following single administration of GZR4
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
AUC₀-∞
Time frame: Day1-Day29
Area under the plasma concentration-time curve from time zero to infinity after single administration of GZR4
3 secondary outcomes
Tmax
Time frame: Day1-Day29
t1/2
Time frame: Day1-Day29
AUC_%Extrap
Time frame: Day1-Day29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GZR4 injection A and GZR4 injection B in people with T2D, run by Gan & Lee Pharmaceuticals. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunda Zhuge (010-56456739, zhugeyunda@ganlee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Day1-Day29). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.