NCT06547502
Completed
Phase 1
The Study of Pharmacokinetics and Safety of a Single Dose of GZR4 Injection in Subjects with Mild to Moderate Renal Impairment and Subjects with Normal Renal Function
Gan and Lee Pharmaceuticals, USA1 site in 1 country16 target enrollmentStarted: July 3, 2024Last updated:
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Gan and Lee Pharmaceuticals, USA
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- AUC0-inf
Overview
Brief Summary
This study will be conducted to investigated the effect of decreased kidney function on PK and safety of GZR4 and to guide dosing recommendations in people with kidney impairment.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent
- •Meeting the pre-defined Glomerular Filtration Rate (GFR) values
Exclusion Criteria
- •Known or suspected hypersensitivity to trial product
- •Drugs known to affect creatinine clearance including cimetidine within 14 days or 5 half-lives prior to the day of dosing of GZR4 and during this trial
- •Individuals who routinely undergo dialysis or have a history of renal transplantation, hepatorenal syndrome, or acute kidney injury
Arms & Interventions
Normal renal function
Experimental
GFR between 90-130 ml/min
Intervention: GZR4 (Drug)
Mildly decreased renal function
Experimental
GFR between 60-90 ml/min
Intervention: GZR4 (Drug)
moderately decreased renal function
Experimental
GFR between 30-60 ml/min
Intervention: GZR4 (Drug)
Outcomes
Primary Outcomes
AUC0-inf
Time Frame: Day1-Day29
AUC0-last
Time Frame: Day1-Day29
Cmax
Time Frame: Day1-Day29
Secondary Outcomes
- T1/2(Day1-Day29)
- Incidence of TEAE(Day1-Day29)
- AUC0-168h(Day1-Day29)
- Tmax(Day1-Day29)
Investigators
Study Sites (1)
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