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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GZR33 Injection | Drug | Administered as once daily subcutaneous dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24h | Area under the plasma concentration-time curve from time 0 to 24 hours | 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. | From Predose to Day12 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma concentration | From Predose to Day7 |
| tmax | Time to reach maximum plasma concentration | From Predose to Day7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency | Gan & Lee Pharmaceuticals. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site | Xingtai | Hebei | China |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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| GZR101 Injection |
| Drug |
Administered as once daily subcutaneous dose |
|
| Placebo | Drug | Administered as once daily subcutaneous dose |
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| Insulin Degludec | Drug | Administered as once daily subcutaneous dose |
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| AUC0-last | Area under the plasma concentration-time curve from time 0 to the last blood sampling time point | From Predose to Day7 |