Healthy ParticipantsPhase 1NCT07918898
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
A Phase 1 study testing GZR101 80 Injection, GZR33 Injection and Insulin Aspart Injection in people with Healthy Participants, run by Gan & Lee Pharmaceuticals..
Trial summary
This trial is conducted in China. This study will be conducted to evaluate pharmacokinetic/pharmacodynamic characteristics and safety of single administration of GZR101-80 Injection with separately injected, simultaneous doses of GZR33 Injection and Insulin Aspart in healthy participants Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- GZR101 80 Injection, GZR33 Injection and Insulin Aspart Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 29 Oct 2026to 2 Feb 2027
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily signed the informed consent form (ICF), was amenable to subcutaneous injection, had fully understood the study content, procedures and potential adverse reactions, and was able to comply with the contraindications and restrictions specified in this protocol.
- Male, aged between 18 and 45 years (both inclusive) at the time of ICF.
Who cannot join
- Subjects with allergic diathesis, or a medical history of allergic diseases such as bronchial asthma and eczema.
- Subjects with abnormal findings for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antigen and antibody combined assay, or treponema pallidum antibody test at screening.
- Subjects who donated blood or had blood loss of ≥ 400 mL within 6 months prior to screening, or intend to donate blood during the study.
- Subjects with a history of drug abuse prior to screening, or with a positive drug abuse screening result at screening.
- Subjects with an average daily cigarette consumption of ≥5 cigarettes within 3 months prior to screening, or those who refuse to abstain from smoking throughout the study period.
- Subjects with a history of vasovagal syncope related to needles or blood, difficulty in blood collection, or intolerance to venipuncture for blood sampling.
- Subjects who are employees of the investigator or the study site, or family members of such employees or investigators, or subjects whom the investigator considers otherwise unsuitable for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I Study Comparing Pharmacokinetic/Pharmacodynamic Characteristics and Safety of Single Administration of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart in Healthy Participants
This trial is conducted in China. This study will be conducted to evaluate pharmacokinetic/pharmacodynamic characteristics and safety of single administration of GZR101-80 Injection with separately injected, simultaneous doses of GZR33 Injection and Insulin Aspart in healthy participants
- Conditions
- Healthy Participants
- Being tested
- GZR101 80 Injection, GZR33 Injection, Insulin Aspart Injection
- Keywords
- Healthy Participants, Pharmacokinetic, Pharmacodynamic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR101 80 InjectionDrug
Single dose. Administered s.c.
GZR33 InjectionDrug
Single dose. Administered s.c.
Insulin Aspart InjectionDrug
Single dose. Administered s.c.
| Study group | Role | What they receive |
|---|---|---|
| GZR101 80 Injection | Experimental | Not described Receives: Drug: GZR101 80 Injection |
| GZR33 Injection + Insulin Aspart Injection | Experimental | Not described Receives: Drug: GZR33 Injection; Drug: Insulin Aspart Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCIAsp,0-6h
Measured: 0-6 hours after dosing
AUC GZR33, 0-24h
Measured: 0-24 hours after dosing
Secondary outcomes (3)
AUCGZR33, 0-∞
Measured: 0-120 hours after dosing
AUC IAsp, 0-∞
Measured: 0-120 hours after dosing
Incidence of adverse events
Measured: 0-120 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start29 Oct 2026 (estimated)
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT07918898
- Sponsor's protocol ID
- GZR101-T2D-103
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 5 Nov 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Comparing Pharmacokinetic/Pharmacodynamic Characteristics and Safety of Single Administration of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart in Healthy Participants
- ClinicalTrials.gov ID
- NCT07918898
- Acronym / sponsor ID
- GZR101-T2D-103
- Conditions
- Healthy Participants
- Keywords
- Healthy Participants, Pharmacokinetic, Pharmacodynamic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Gan & Lee Pharmaceuticals.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 5 Nov 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 trial is conducted in China. This study will be conducted to evaluate pharmacokinetic/pharmacodynamic characteristics and safety of single administration of GZR101-80 Injection with separately injected, simultaneous doses of GZR33 Injection and Insulin Aspart in healthy participants
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GZR101 80 Injection | Experimental | Drug: GZR101 80 Injection |
| GZR33 Injection + Insulin Aspart Injection | Experimental | Drug: GZR33 Injection, Drug: Insulin Aspart Injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Voluntarily signed the informed consent form (ICF), was amenable to subcutaneous injection, had fully understood the study content, procedures and potential adverse reactions, and was able to comply with the contraindications and restrictions specified in this protocol.
- Male, aged between 18 and 45 years (both inclusive) at the time of ICF.
Key exclusion criteria (7 listed)
- Subjects with allergic diathesis, or a medical history of allergic diseases such as bronchial asthma and eczema.
- Subjects with abnormal findings for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antigen and antibody combined assay, or treponema pallidum antibody test at screening.
- Subjects who donated blood or had blood loss of ≥ 400 mL within 6 months prior to screening, or intend to donate blood during the study.
- Subjects with a history of drug abuse prior to screening, or with a positive drug abuse screening result at screening.
- Subjects with an average daily cigarette consumption of ≥5 cigarettes within 3 months prior to screening, or those who refuse to abstain from smoking throughout the study period.
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 |
|---|---|---|
| GZR101 80 InjectionSingle dose. Administered s.c. | Drug | GZR101 80 Injection |
| GZR33 InjectionSingle dose. Administered s.c. | Drug | GZR33 Injection + Insulin Aspart Injection |
| Insulin Aspart InjectionSingle dose. Administered s.c. | Drug | GZR33 Injection + Insulin Aspart Injection |
Primary outcome
AUCIAsp,0-6h
Time frame: 0-6 hours after dosing
AUC GZR33, 0-24h
Time frame: 0-24 hours after dosing
3 secondary outcomes
AUCGZR33, 0-∞
Time frame: 0-120 hours after dosing
AUC IAsp, 0-∞
Time frame: 0-120 hours after dosing
Incidence of adverse events
Time frame: 0-120 hours after dosing
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 5 Nov 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GZR101 80 Injection, GZR33 Injection and Insulin Aspart Injection in people with Healthy Participants, run by Gan & Lee Pharmaceuticals..
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 2 inclusion and 7 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yunhong Wu (010-56456739, YunhongWu@ganlee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCIAsp,0-6h (time frame: 0-6 hours after dosing). The study lists 2 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 5 Nov 2026.