to Evaluate the Pharmacokinetic Characteristics and Bioavailability of Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection（GenSci094） in Healthy Male Subjects Before and After a Change in Manufacturing Site
Overview
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- AUC0-t（（area under the time curve of blood concentration at time from 0 to the last time point selected
Overview
Brief Summary
The bioavailability study is intended to evaluate the pharmacokinetic (PK) characteristics and the bioavailability of the two formulations in humans before and after the change of production site, in order to assess the possible impact of the site change on the pharmacokinetic characteristics of the drug and to clarify whether the two formulations are comparable before and after the change.
Detailed Description
This study used a single-center, open, randomized, single-dose, parallel-controlled trial design, and the study drug consisted of 1) the test drug (GenSci094 after the change in manufacturing site) and 2) the control drug (GenSci094 before the change in manufacturing site). Screened 48 healthy male subjects were randomly assigned to Group A (test drug) or Group B (control drug), randomized at timeprevious day（ D-1）, admitted to the Phase I clinical trial ward and put on a uniform diet; received 150 μg subcutaneous injection administration of the study drug on the following day (D1), and blood was collected for PK and immunogenicity up today 18（ D18）; and completed a safety telephone follow-up on day 25（D25）.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
GenSci094
Participants received a single subcutaneous (SC) injection of 150 µg GenSci094 on day 1 pre-meal，PK and immunogenicity blood collection to day18， safety call follow-up completed at day 25
Intervention: GenSci094 (Drug)
Outcomes
Primary Outcomes
AUC0-t（（area under the time curve of blood concentration at time from 0 to the last time point selected
Time Frame: Venous blood was collected at 16 time points: 2h before, 6h, 12h, 24h, 30h, 36h, 48h (D3), 54h, 60h, 72h (D4), 96h (D5), 120h (D6), 192h (D9), 264h (D12), 336h (D15), and 408h (D18) for the determination of the concentration of GenSci094 in serum.]
AUC0-∞（Area Under the Serum Concentration-time Curve Extrapolated to Infinity [AUC(0-∞)
Time Frame: Venous blood was collected at 16 time points: 2h before, 6h, 12h, 24h, 30h, 36h, 48h (D3), 54h, 60h, 72h (D4), 96h (D5), 120h (D6), 192h (D9), 264h (D12), 336h (D15), and 408h (D18) for the determination of the concentration of GenSci094 in serum.
Safety and tolerability: Evaluation of safety through the adverse affects investigation
Time Frame: The entire study period begins when the subject signs the written ICF and ends with the completion of the last visit
Tmax（Time to Reach a Maximum GenSci094 Serum Concentration (Tmax)
Time Frame: Venous blood was collected at 16 time points: 2h before, 6h, 12h, 24h, 30h, 36h, 48h (D3), 54h, 60h, 72h (D4), 96h (D5), 120h (D6), 192h (D9), 264h (D12), 336h (D15), and 408h (D18) for the determination of the concentration of GenSci094 in serum.
T1/2（GenSci094 Apparent Terminal Half-life (T1/2)
Time Frame: Venous blood was collected at 16 time points: 2h before, 6h, 12h, 24h, 30h, 36h, 48h (D3), 54h, 60h, 72h (D4), 96h (D5), 120h (D6), 192h (D9), 264h (D12), 336h (D15), and 408h (D18) for the determination of the concentration of GenSci094 in serum.
12-lead ECG：Heart rate, PR interval, QRS, QTc interval，Post-medication results were analyzed for descriptive statistics on change from baseline values
Time Frame: 0-408hours
Cmax（Maximum Serum Concentration of GenSci094(Cmax)
Time Frame: Venous blood was collected at 16 time points: 2h before, 6h, 12h, 24h, 30h, 36h, 48h (D3), 54h, 60h, 72h (D4), 96h (D5), 120h (D6), 192h (D9), 264h (D12), 336h (D15), and 408h (D18) for the determination of the concentration of GenSci094 in serum.
Laboratory tests，physical examination，Post-medication results were analyzed for descriptive statistics on change from baseline values
Time Frame: 0-408hours
Secondary Outcomes
- Immunogenicity: Anti-drug antibody (ADA)(Immunogenicity blood sample collection time points: within 1h before drug administration, 192h (D9), 408h (D18) for a total of 3 time points, and venous blood collected for serum immunogenicity analysis evaluation during early withdrawal visits])