Healthy SubjectsPhase 1NCT06556641
A Clinical Study of GZR33 and GZR101 in Healthy Subjects
A Phase 1 study testing GZR33 Injection, GZR101 Injection and Insulin Degludec in people with Healthy Subjects, run by Gan and Lee Pharmaceuticals, USA at 1 site in China.
Trial summary
This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of GZR33 and GZR101 in healthy adult male subjects.This study consists of Part A and Part B. 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 Subjects
- What is being tested?
- GZR33 Injection, GZR101 Injection and Insulin Degludec
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2022to 3 Feb 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
- 1. Voluntarily participated in the study and signed the informed consent form (ICF);
- 2.Chinese healthy male adult subjects aged 18-45 years old (including 18 and 45 years old as of the date of signing the ICF);
- 3.During screening period, the body mass index (BMI) between 19.0 and 24.0 kg/m2, inclusive, and a body weight>50 kg (not containing 50kg).
Who cannot join
- 1.History of drug abuse within one year prior to screening.
- 2.History of alcohol abuse within 6 months prior to screening (alcohol abuse is defined as more than 14 units weekly: 1 unit of alcohol equals to 360 mL of beer, 150 mL of wine, or 45 mL of 40% alcohol).The subject who smoke more than 5 cigarettes per day within 3 months prior to screening, smoke within 48 h prior to the use of the investigational drug, and is unwilling to refrain from smoking and drinking during the trial period.
- 3.Allergic constitution, or history of bronchial asthma, hives, eczema and other allergic diseases (except mild asymptomatic seasonal allergy), or known allergy to the investigational drug or its excipients, hypersensitivity or intolerance.
- 4.Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, syphilis spiral test or human immunodeficiency virus (HIV) antibodies positive.
- 5.History of needle and blood sickness, and subject couldn't tolerate venipuncture for blood collection, or be difficult to collect blood.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ib Clinical Study on the Safety, Tolerance, Pharmacokinetics, and Pharmacodynamics of GZR33 and GZR101 in Healthy Adult Male Subjects
This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of GZR33 and GZR101 in healthy adult male subjects.This study consists of Part A and Part B.
Part A is a randomized, open-label, single-dose, two-sequence, two-period, cross-over design comparative study evaluating the PD and PK characteristics of GZR33 and Insulin Degludec Injection.
Part B is a randomized, double-blind, placebo-controlled, multiple-dose, parallel-group design study evaluating the safety, tolerability, immunogenicity, and PK of GZR33 and GZR101.
- Conditions
- Healthy Subjects
- Being tested
- GZR33 Injection, GZR101 Injection, Placebo, Insulin Degludec
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR33 InjectionDrug
Administered as once daily subcutaneous dose
GZR101 InjectionDrug
Administered as once daily subcutaneous dose
PlaceboDrug
Administered as once daily subcutaneous dose
Insulin DegludecDrug
Administered as once daily subcutaneous dose
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Part A : randomized, open-label, single-dose, two-sequence, two-period, cross-over
Single administration of GZR33, washout period of 14 days, followed by single administration of Insulin Degludec
Single administration of Insulin Degludec, washout period of 14 days, followed by single administration of GZR33 Receives: Drug: GZR33 Injection; Drug: Insulin Degludec |
| Part B | Experimental | Part B: randomized, double-blind, placebo-controlled, multiple-dose, parallel
Drug: GZR33 Injection Participants will receive once daily GZR33 Injection or placebo for 6 days, s.c.
Drug: GZR101 Injection Participants will receive once daily GZR101 Injection or placebo for 6 days, s.c. Receives: Drug: GZR33 Injection; Drug: GZR101 Injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-24h
Area under the plasma concentration-time curve from time 0 to 24 hours
Measured: From 0 to 24 hours
Incidence of adverse events (AE)
Any changes or abnormal results in the following safety variables: incidence of adverse events (AE), including but not limited to hypoglycemic reactions, injection site reactions, clinical laboratory tests, 12-lead ECG, vital signs, physical examination, and local tolerability at the injection site.
Measured: From Predose to Day12
Secondary outcomes (3)
Cmax
Maximum plasma concentration
Measured: From Predose to Day7
tmax
Time to reach maximum plasma concentration
Measured: From Predose to Day7
AUC0-last
Area under the plasma concentration-time curve from time 0 to the last blood sampling time point
Measured: From Predose to Day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start17 Dec 2022
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency, Study director, Gan & Lee Pharmaceuticals.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556641
- Sponsor's protocol ID
- GL-GZR-CH1013
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- 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 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Clinical Study on the Safety, Tolerance, Pharmacokinetics, and Pharmacodynamics of GZR33 and GZR101 in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT06556641
- Acronym / sponsor ID
- GL-GZR-CH1013
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2022 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 16 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 study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of GZR33 and GZR101 in healthy adult male subjects.This study consists of Part A and Part B.
Part A is a randomized, open-label, single-dose, two-sequence, two-period, cross-over design comparative study evaluating the PD and PK characteristics of GZR33 and Insulin Degludec Injection.
Part B is a randomized, double-blind, placebo-controlled, multiple-dose, parallel-group design study evaluating the safety, tolerability, immunogenicity, and PK of GZR33 and GZR101.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: GZR33 Injection, Drug: Insulin DegludecPart A : randomized, open-label, single-dose, two-sequence, two-period, cross-over Single administration of GZR33, washout period of 14 days, followed by single administration of Insulin Degludec Single administration of Insulin Degludec, washout period of 14 days, followed by single administration of GZR33 |
| Part B | Experimental | Drug: GZR33 Injection, Drug: GZR101 Injection, Drug: PlaceboPart B: randomized, double-blind, placebo-controlled, multiple-dose, parallel Drug: GZR33 Injection Participants will receive once daily GZR33 Injection or placebo for 6 days, s.c. Drug: GZR101 Injection Participants will receive once daily GZR101 Injection or placebo for 6 days, s.c. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1. Voluntarily participated in the study and signed the informed consent form (ICF);
- 2.Chinese healthy male adult subjects aged 18-45 years old (including 18 and 45 years old as of the date of signing the ICF);
- 3.During screening period, the body mass index (BMI) between 19.0 and 24.0 kg/m2, inclusive, and a body weight>50 kg (not containing 50kg).
Key exclusion criteria (5 listed)
- 1.History of drug abuse within one year prior to screening.
- 2.History of alcohol abuse within 6 months prior to screening (alcohol abuse is defined as more than 14 units weekly: 1 unit of alcohol equals to 360 mL of beer, 150 mL of wine, or 45 mL of 40% alcohol).The subject who smoke more than 5 cigarettes per day within 3 months prior to screening, smoke within 48 h prior to the use of the investigational drug, and is unwilling to refrain from smoking and drinking during the trial period.
- 3.Allergic constitution, or history of bronchial asthma, hives, eczema and other allergic diseases (except mild asymptomatic seasonal allergy), or known allergy to the investigational drug or its excipients, hypersensitivity or intolerance.
- 4.Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, syphilis spiral test or human immunodeficiency virus (HIV) antibodies positive.
- 5.History of needle and blood sickness, and subject couldn't tolerate venipuncture for blood collection, or be difficult to collect blood.
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 |
|---|---|---|
| GZR33 InjectionAdministered as once daily subcutaneous dose | Drug | Part A, Part B |
| GZR101 InjectionAdministered as once daily subcutaneous dose | Drug | Part B |
| PlaceboAdministered as once daily subcutaneous dose | Drug | Part B |
| Insulin DegludecAdministered as once daily subcutaneous dose | Drug | Part A |
Primary outcome
AUC0-24h
Time frame: From 0 to 24 hours
Area under the plasma concentration-time curve from time 0 to 24 hours
Incidence of adverse events (AE)
Time frame: From Predose to Day12
Any changes or abnormal results in the following safety variables: incidence of adverse events (AE), including but not limited to hypoglycemic reactions, injection site reactions, clinical laboratory tests, 12-lead ECG, vital signs, physical examination, and local tolerability at the injection site.
3 secondary outcomes
Cmax
Time frame: From Predose to Day7
tmax
Time frame: From Predose to Day7
AUC0-last
Time frame: From Predose to Day7
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 16 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.
Clinical Transparency study director
Gan & Lee Pharmaceuticals.
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 GZR33 Injection, GZR101 Injection and Insulin Degludec in people with Healthy Subjects, 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 16 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?
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?
AUC0-24h (time frame: From 0 to 24 hours). 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 16 Aug 2024.