Study Site 01
Tianjin, China
NCT Number: NCT06548932
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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Notify Me18 year–45 year
Male
Interventional
Phase 1
Tianjin, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single dose
A single dose
A single dose
Time frame: From Predose to Day14 after a single dose
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 0 hours to 24 hours after a single dose
Maximum glucose infusion rate
Time frame: From Predose to Day8 after a single dose
Area under the plasma concentration curve of GZR33 from 0 to 24 hours
Time frame: From 0 hours to 12 hours after a single dose
Area under the plasma concentration curve of insulin aspart from 0 to 12 hours
Gan and Lee Pharmaceuticals, USA
Industry
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerance, PK and PD Parameters of Single Dose Escalation of GZR33 and Single Administration of GZR101 in Healthy Male Adult 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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