DiabetesPhase 1NCT06548815
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single-dose GZR4
A Phase 1 study testing GZR4 in people with Diabetes, run by Gan and Lee Pharmaceuticals, USA at 1 site in China.
Trial summary
This trial is conducted in China. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single-dose GZR4. 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
- Diabetes
- What is being tested?
- GZR4
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 29 Aug 2022to 24 Mar 2023
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese healthy male adult subjects aged 18-45 years old
- Body mass index [BMI between 19.0-24.0 kg/m2
- Hemoglobin A1c (HbA1c)≤6%
Who cannot join
- Abnormalities that were assessed by the investigators to be clinically significant at screening included vital signs, physical examination, laboratory testing, anteroposterior and lateral chest radiography, and 12-lead ECG
- Known severe allergies (e.g., allergy to more than 3 allergens, allergic asthma affecting the lower respiratory tract, allergy requiring glucocorticoid treatment) or known allergic history to the ingredients of the investigational drug used in this study
- Participants had donated blood ≥ 200 mL within 6 months before screening, or had donated blood components, or had a total blood loss of ≥ 200 mL due to any reason, or history of blood transfusion or use of blood products
- Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive
- Participated in other clinical trials and used investigational drugs or medical devices within 3 months before screening
Trial locations and contacts
1 site in 1 country.
China1 site
Gan & Lee Pharmaceuticals Co., Ltd
Beijing, Beijing Municipality, 100000
About this study
Official title: A Single-center, Single-administration, Randomized, Placebo-controlled, Dose-escalation Trial Evaluated the Safety, Tolerability, PK, and PD Parameters of GZR4 in Healthy Male Adult Subjects
This trial is conducted in China. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single-dose GZR4.
- Conditions
- Diabetes
- Being tested
- GZR4, Placebo
- Keywords
- GZR4, PK
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR4Drug
Ascending single doses - 4 dose levels.
PlaceboDrug
Ascending single doses - 4 dose levels.
| Study group | Role | What they receive |
|---|---|---|
| GZR4 | Experimental | s.c, single dose Receives: Drug: GZR4 |
| Placebo | Placebo comparator | s.c, single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of TEAE
Measured: Baseline to Day29
Secondary outcomes (8)
GIRmax
Measured: Day2-Day3
Tmax,GIR
Measured: Day2-Day3
AUCGIR
Measured: Day2-Day3/Day7-Day8
Cmax
Measured: Baseline to Day29
Tmax,GZR4
Measured: Baseline to Day29
T1/2
Measured: Baseline to Day29
AUC0-inf
Measured: Baseline to Day29
AUC0-last
Measured: Baseline to Day29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start29 Aug 2022
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548815
- Sponsor's protocol ID
- GL-GZR-CH1004
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-administration, Randomized, Placebo-controlled, Dose-escalation Trial Evaluated the Safety, Tolerability, PK, and PD Parameters of GZR4 in Healthy Male Adult Subjects
- ClinicalTrials.gov ID
- NCT06548815
- Acronym / sponsor ID
- GL-GZR-CH1004
- Conditions
- Diabetes
- Keywords
- GZR4, PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 12 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.
This trial is conducted in China. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single-dose GZR4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GZR4 | Experimental | Drug: GZR4s.c, single dose |
| Placebo | Placebo comparator | Drug: Placebos.c, single dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chinese healthy male adult subjects aged 18-45 years old
- Body mass index [BMI between 19.0-24.0 kg/m2
- Hemoglobin A1c (HbA1c)≤6%
Key exclusion criteria (5 listed)
- Abnormalities that were assessed by the investigators to be clinically significant at screening included vital signs, physical examination, laboratory testing, anteroposterior and lateral chest radiography, and 12-lead ECG
- Known severe allergies (e.g., allergy to more than 3 allergens, allergic asthma affecting the lower respiratory tract, allergy requiring glucocorticoid treatment) or known allergic history to the ingredients of the investigational drug used in this study
- Participants had donated blood ≥ 200 mL within 6 months before screening, or had donated blood components, or had a total blood loss of ≥ 200 mL due to any reason, or history of blood transfusion or use of blood products
- Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive
- Participated in other clinical trials and used investigational drugs or medical devices within 3 months before screening
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 |
|---|---|---|
| GZR4Ascending single doses - 4 dose levels. | Drug | GZR4 |
| PlaceboAscending single doses - 4 dose levels. | Drug | Placebo |
Primary outcome
Incidence of TEAE
Time frame: Baseline to Day29
8 secondary outcomes
GIRmax
Time frame: Day2-Day3
Tmax,GIR
Time frame: Day2-Day3
AUCGIR
Time frame: Day2-Day3/Day7-Day8
Cmax
Time frame: Baseline to Day29
Tmax,GZR4
Time frame: Baseline to Day29
T1/2
Time frame: Baseline to Day29
AUC0-inf
Time frame: Baseline to Day29
AUC0-last
Time frame: Baseline to Day29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Diabetes, 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 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: finished, as of the sponsor's last update on 12 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of TEAE (time frame: Baseline to Day29). 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 12 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.