Diabetes Mellitus, Type 2Phase 1NCT06554054
A Study of GZR18 Tablet in Chinese Healthy Subjects
A Phase 1 study testing GZR18 in people with Diabetes Mellitus, Type 2, run by Gan and Lee Pharmaceuticals, USA at 1 site in China.
Trial summary
The aim of the trial is to investigate the the bioavailability, pharmacokinetics, pharmacodynamics, safety and tolerance of single and multiple doses of GZR18 tablet in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- GZR18
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 9 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects sign informed consent voluntarily.
- Age 18-55 at screening (both included)，male or female（male only for part A）.
- At screening, 20.0 kg/m2 ≤ BMI ≤ 24.9 kg/m2, body weight≥54.0 kg.
- Female subjects were HCG negative at screening and baseline
Who cannot join
- Female subjects who are pregnant or lactating at screening.
- History of drug abuse within 1 year prior to screening, with a positive drug abuse screening result at screening or before dosing.
- Abnormal fasting blood glucose at screening, or impaired glucose tolerance, or history of hypoglycemia within 3 months prior to screening.
- History of the following diseases with a definite diagnosis within 6 months prior to screening: cardiovascular disease, hematologic disease, respiratory disease, abnormal liver function due to acute and chronic hepatitis or other reasons, abnormal renal function, endocrine and metabolic system disease, neuropsychiatric disease, skin and subcutaneous tissue disease, musculoskeletal system disease, immune system disease, or the presence of other diseases that may interfere with the interpretation of study results.
- Those who have any food allergies or special dietary requirements and cannot follow a uniform diet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Phase I Trial to Evaluate the Bioavailability, Pharmacokinetics, Pharmacodynamics, Safety and Tolerance of GZR18 Tablet and Evaluate the Effect of Meal Time on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerance of GZR18 Tablet in Chinese Healthy Adult Subjects
The aim of the trial is to investigate the the bioavailability, pharmacokinetics, pharmacodynamics, safety and tolerance of single and multiple doses of GZR18 tablet in healthy subjects.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- GZR18
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR18Drug
Oral administered the GZR18 tablet
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Part A (single dose) | Experimental | Drug: GZR18 tablet Three single-dose cohorts of GZR18 tablet administered according to an ascending dose design. Progression to next dose will be based on safety evaluation. Sequential cohorts.
Active Comparator: GZR18 injection Single-dose administered s.c. (under the skin). Receives: Drug: GZR18 |
| Experimental: Part B (multiple dose) | Experimental | Drug:GZR18 tablet GZR18 tablet administered as two multiple dose cohorts, to test the different meal time effect.
Parallel assignment Receives: Drug: GZR18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE and SAE
Incidence of Adverse Events and Severe Adverse Events
Measured: 22 days and 35 days
Relative bioavailability of GZR18 tablet
Fr =AUC0-t(GZR18 tablets)/AUC0-t(GZR18 injection)×100%
Measured: 22 days and 35 days
ADA and NAb
Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab)
Measured: 22 days and 35 days
Secondary outcomes (3)
Cmax
Maximum plasma drug concentration
Measured: 22 days and 35 days
AUC0-t
Area under the curve from 0 through the time of the last accurately measurable concentration
Measured: 22 days and 35 days
AUC0-24h
Area under the curve from 0 h to 24 hours
Measured: 22 days and 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Apr 2024
- Primary completion9 Dec 2024 (estimated)
- Study completion9 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiao Min, Ph.D, Study director, Gan & Lee Pharmaceuticals Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554054
- Sponsor's protocol ID
- GL-GLP-CH1010
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Phase I Trial to Evaluate the Bioavailability, Pharmacokinetics, Pharmacodynamics, Safety and Tolerance of GZR18 Tablet and Evaluate the Effect of Meal Time on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerance of GZR18 Tablet in Chinese Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06554054
- Acronym / sponsor ID
- GL-GLP-CH1010
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 9 Dec 2024 (estimated)
- Study completion
- 9 Dec 2024 (estimated)
- First posted
- 14 Aug 2024 (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.
The aim of the trial is to investigate the the bioavailability, pharmacokinetics, pharmacodynamics, safety and tolerance of single and multiple doses of GZR18 tablet in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Part A (single dose) | Experimental | Drug: GZR18Drug: GZR18 tablet Three single-dose cohorts of GZR18 tablet administered according to an ascending dose design. Progression to next dose will be based on safety evaluation. Sequential cohorts. Active Comparator: GZR18 injection Single-dose administered s.c. (under the skin). |
| Experimental: Part B (multiple dose) | Experimental | Drug: GZR18Drug:GZR18 tablet GZR18 tablet administered as two multiple dose cohorts, to test the different meal time effect. Parallel assignment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects sign informed consent voluntarily.
- Age 18-55 at screening (both included)，male or female（male only for part A）.
- At screening, 20.0 kg/m2 ≤ BMI ≤ 24.9 kg/m2, body weight≥54.0 kg.
- Female subjects were HCG negative at screening and baseline
Key exclusion criteria (5 listed)
- Female subjects who are pregnant or lactating at screening.
- History of drug abuse within 1 year prior to screening, with a positive drug abuse screening result at screening or before dosing.
- Abnormal fasting blood glucose at screening, or impaired glucose tolerance, or history of hypoglycemia within 3 months prior to screening.
- History of the following diseases with a definite diagnosis within 6 months prior to screening: cardiovascular disease, hematologic disease, respiratory disease, abnormal liver function due to acute and chronic hepatitis or other reasons, abnormal renal function, endocrine and metabolic system disease, neuropsychiatric disease, skin and subcutaneous tissue disease, musculoskeletal system disease, immune system disease, or the presence of other diseases that may interfere with the interpretation of study results.
- Those who have any food allergies or special dietary requirements and cannot follow a uniform diet.
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 |
|---|---|---|
| GZR18Oral administered the GZR18 tablet | Drug | Experimental: Part A (single dose), Experimental: Part B (multiple dose) |
Primary outcome
AE and SAE
Time frame: 22 days and 35 days
Incidence of Adverse Events and Severe Adverse Events
Relative bioavailability of GZR18 tablet
Time frame: 22 days and 35 days
Fr =AUC0-t(GZR18 tablets)/AUC0-t(GZR18 injection)×100%
ADA and NAb
Time frame: 22 days and 35 days
Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab)
3 secondary outcomes
Cmax
Time frame: 22 days and 35 days
AUC0-t
Time frame: 22 days and 35 days
AUC0-24h
Time frame: 22 days and 35 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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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. This study is not recruiting at the moment.
Xiao Min, Ph.D study director
Gan & Lee Pharmaceuticals Co., Ltd
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 GZR18 in people with Diabetes Mellitus, Type 2, run by Gan and Lee Pharmaceuticals, USA 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 4 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: status not confirmed, as of the sponsor's last update on 14 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE and SAE (time frame: 22 days and 35 days). 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 14 Aug 2024.