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This is a randomized, double-blind, placebo-controlled, single dose phase I clinical study. It is divided into two parts: part A , a single ascending dose assessment of GZR33, and partB, a single dose evaluation of GZR101.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GZR33 Injection | Experimental | Participants will receive GZR33 Injection or placebo, s.c. a single dose (Part A) |
|
| GZR101 Injection | Experimental | Participants will receive GZR101 Injection or placebo, s.c. a single dose (Part B) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GZR33 Injection | Drug | A single dose |
| |
| GZR101 Injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Day14 after a single dose |
| Measure | Description | Time Frame |
|---|---|---|
| GIRmax | Maximum glucose infusion rate | From 0 hours to 24 hours after a single dose |
| AUCGZR33,0-24 h | Area under the plasma concentration curve of GZR33 from 0 to 24 hours |
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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 01 | Tianjin | China |
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| Drug |
A single dose |
|
| Placebo | Drug | A single dose |
|
| From Predose to Day8 after a single dose |
| AUCIAsp,0-12 h | Area under the plasma concentration curve of insulin aspart from 0 to 12 hours | From 0 hours to 12 hours after a single dose |