Study Site
Xingtai, Hebei, China
NCT Number: NCT06556641
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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Notify Me18 year–45 year
Male
Interventional
Phase 1
Xingtai, Hebei, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered as once daily subcutaneous dose
Administered as once daily subcutaneous dose
Administered as once daily subcutaneous dose
Administered as once daily subcutaneous dose
Time frame: From 0 to 24 hours
Area under the plasma concentration-time curve from time 0 to 24 hours
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.
Time frame: From Predose to Day7
Maximum plasma concentration
Time frame: From Predose to Day7
Time to reach maximum plasma concentration
Time frame: From Predose to Day7
Area under the plasma concentration-time curve from time 0 to the last blood sampling time point
Gan and Lee Pharmaceuticals, USA
Industry
Phase Ib Clinical Study on the Safety, Tolerance, Pharmacokinetics, and Pharmacodynamics of GZR33 and GZR101 in Healthy Adult Male Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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