NCT06778304

Bioequivalence Clinical Trial of Recombinant Human Follicle-stimulating Hormone JZB30

A Randomized, Controlled, Open-label, Two-Period, Double-Crossover, Bioequivalence Clinical Trial: Comparing the Clinical Similarity of Recombinant Human Follicle-Stimulating Hormone JZB30 Injection With the Comparator Drug Gonal-f®

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: West China Second University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Bioequivalence
• Healthy Volunteers
• Pharmacokinetics
• Safety
• Immunogenicity

Interventions

Type	Name	Description
DRUG	Gonal F	The reference formulation is the recombinant human follicle-stimulating hormone injection (Gonal-f®) originally developed and produced by Merck Serono
DRUG	jzb30	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.

Timeline

• Start date: 2021-01-04
• Primary completion: 2021-11-16
• Completion: 2022-01-17
• First posted: 2025-01-16
• Last updated: 2025-01-16

Locations

1 site across 1 country: China