NCT06599528

A Comparing Study Between SJ04 and Ovidrel® in Healthy Subjects

A Phase I Clinical Trial to Compare the Pharmacokinetics, Safety and Immunogenicity of SJ04 and Ovidrel® in Healthy Female Subjects in China

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Suzhou Centergene Pharmaceuticals Co.,Ltd. · Industry
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a single-centre, randomised, open-label, single-dose, two-cycle, double-crossover study to compare the pharmacokinetics of SJ04 and Ovidrel® in healthy female subjects. Received a single subcutaneous injection administration of SJ04 Injection or Ovidrel®, both administered at a dose of 250 μg, once per cycle, and cross-administered after a washout period.

Detailed description

SJ04 is a biosimilar of Ovidrel® and is highly similar to Ovidrel®. The purpose of this study was to evaluate the similarity of pharmacokinetics (PK) between recombinant human chorionic gonadotropin injection (SJ04) and Ovidrel® after administration by a single subcutaneous injection in healthy Chinese female subjects. Forty-eight screened healthy female subjects were randomly divided into 2 groups, the T-R group and the R-T group, with 24 subjects in each group. On the morning of the day of administration, they received SJ04 injection or Ovidrel® single subcutaneous injection according to the randomisation table, both at a dose of 250 μg, once per cycle, and crossed over after a washout period.

Conditions

• Assisted Reproductive Technology
• Female Infertility

Interventions

Type	Name	Description
DRUG	T-R (Test-Reference drug)	T: SJ04 (Test drug) R: Ovidrel® (Referecne drug) 250 μg of SJ04 injection or Oviderl®, administered subcutaneously once at two week intervals.
DRUG	R-T (Reference-Test drug)	R: Ovidrel®(Referecne drug) T: SJ04 (Test drug) 250 μg of SJ04 or Oviderl®, administered subcutaneously once at two week intervals.

Timeline

• Start date: 2024-08-12
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-09-19
• Last updated: 2025-02-10

Locations

1 site across 1 country: China