Study site 01
Beijing, China
NCT Number: NCT06974487
This trial is a randomized, double-blind, three-period crossover Phase I Clinical Study conducted in Chinese adult overweight subjects to evaluate the safety, tolerability, PK and PD profiles of a single dose of GZR102 injection versus GZR4 injection and GZR18 injection given separately.
Subjects undergo a screening phase of up to 3 weeks (D-21 to D-3). Eligible subjects are randomized in a 1:1:1:1:1:1 ratio into six dosing sequences, receiving single doses of GZR102 injection, GZR4 injection, and GZR18 injection across 3 cycles. A washout period of at least 1 week separates each cycle.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Interventional
Phase 1
Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will get a single dose of GZR102 injection (fixed-ratio combination of GZR4 and GZR18).
Participants will get a single dose of GZR4 injection
Participants will get a single dose of GZR18 injection
Time frame: Day 36 (end of period)
Area under the plasma concentration-time curve at 0 h to last observation time-point after a single dose.
Time frame: Day 36 (end of period)
Area under the plasma concentration-time curve at 0 h to infinity after a single dose.
Time frame: Day 36 (end of period)
Treatment-emergent adverse events in terms of number of subject
Time frame: Day 36 (end of period)
Number of subjects, number of events and incidence of treatment-emergent hypoglycemia.
Time frame: Day 36 (end of period)
Including anti-drug antibody (ADA) and neutralizing antibody (NAb).
Time frame: Day 36 (end of period)
Maximum plasma concentration
Contact information is provided by the study sponsor or research team.
Gan & Lee Pharmaceuticals.
Industry
A Randomized, Double-Blind, Crossover Phase I Clinical Study to Evaluate the Safety, Tolerability, PK and PD Profiles of a Single Dose of GZR102 Injection Versus GZR4 Injection and GZR18 Injection Given Separately in Chinese Adult Overweight 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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