Study Site 01
Beijing, China
NCT Number: NCT06554054
The aim of the trial is to investigate the the bioavailability, pharmacokinetics, pharmacodynamics, safety and tolerance of single and multiple doses of GZR18 tablet in healthy subjects.
This study is active but is not currently recruiting participants.
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Beijing, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral administered the GZR18 tablet
Time frame: 22 days and 35 days
Incidence of Adverse Events and Severe Adverse Events
Time frame: 22 days and 35 days
Fr =AUC0-t(GZR18 tablets)/AUC0-t(GZR18 injection)×100%
Time frame: 22 days and 35 days
Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab)
Time frame: 22 days and 35 days
Maximum plasma drug concentration
Time frame: 22 days and 35 days
Area under the curve from 0 through the time of the last accurately measurable concentration
Time frame: 22 days and 35 days
Area under the curve from 0 h to 24 hours
Gan and Lee Pharmaceuticals, USA
Industry
A Randomized, Open Phase I Trial to Evaluate the Bioavailability, Pharmacokinetics, Pharmacodynamics, Safety and Tolerance of GZR18 Tablet and Evaluate the Effect of Meal Time on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerance of GZR18 Tablet in Chinese Healthy 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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