Research Objective: Using the recombinant human follicle-stimulating hormone injection (Gonal-f®) originally developed by Merck Serono as the reference formulation, and the recombinant human follicle-stimulating hormone injection (code: JZB30) produced by Shanghai Jingze Biotechnology Co., Ltd./Chengdu Jingze Biopharmaceutical Co., Ltd. as the test formulation, a single-center, randomized, open-label, two-period, two-crossover designed bioequivalence study was conducted. The study aimed to evaluate the pharmacokinetic behavior, safety, and immunogenicity of the two formulations in healthy adult female Chinese subjects, providing a reference basis for rational clinical use.
A total of 48 healthy adult female participants were enrolled. On Day 1 (D1), they received a single subcutaneous injection of either the test drug or the reference drug. After a washout period of 8 to 10 days, the subjects entered the second period starting on Day 11 (D11) for crossover administration. Pharmacokinetic (PK) blood samples were collected at specified time points, and the concentration of follicle-stimulating hormone (FSH) in the biological samples was measured using a validated electrochemiluminescence assay based on the MSD platform. The obtained PK data were used for pharmacokinetic analysis. Clinical safety assessments were conducted throughout the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
48
The reference formulation is the recombinant human follicle-stimulating hormone injection (Gonal-f®) originally developed and produced by Merck Serono
The test formulation is the recombinant human follicle-stimulating hormone injection (code: JZB30) produced by Shanghai Jingze Biotechnology Co., Ltd./Chengdu Jingze Biopharmaceutical Co., Ltd.
West China Second University Hospital
Chengdu, Sichuan, China
AUC (area under the curve)
To evaluate the bioequivalence between the test formulation (JZB30) and the reference formulation (Gonal-f®) by comparing their pharmacokinetic parameters, including AUC (area under the curve), Cmax (maximum plasma concentration), and Tmax (time to reach maximum concentration), in healthy adult female subjects.
Time frame: First Period: From pre-dose (0 hour) to 168 hours post-dose on Day 1 (D1). Second Period: From pre-dose (0 hour) to 168 hours post-dose on Day 11 (D11)
Cmax (maximum plasma concentration)
To evaluate the bioequivalence between the test formulation (JZB30) and the reference formulation (Gonal-f®) by comparing their pharmacokinetic parameters, including AUC (area under the curve), Cmax (maximum plasma concentration), and Tmax (time to reach maximum concentration), in healthy adult female subjects.
Time frame: First Period: From pre-dose (0 hour) to 168 hours post-dose on Day 1 (D1). Second Period: From pre-dose (0 hour) to 168 hours post-dose on Day 11 (D11)
ADA(Anti-Drug Antibodies)
To evaluate the immunogenicity of the test formulation (JZB30) and the reference formulation (Gonal-f®) by detecting the presence of anti-drug antibodies (ADA) and assessing their potential impact on pharmacokinetics and safety in healthy adult female subjects.
Time frame: First Period: Pre-dose (0 hour) and 168 hours post-dose on Day 1 (D1). Second Period: Pre-dose (0 hour) and 168 hours post-dose on Day 11 (D11). Follow-up: Up to 7 days after the last dose in the second period (Day 18).
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