RecruitingPhase 1NCT06599528

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


Sponsor

Suzhou Centergene Pharmaceuticals Co.,Ltd.

Enrollment

48 participants

Start Date

Aug 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying R-T (Reference-Test drug) and T-R (Test-Reference drug) for people with female infertility and assisted reproductive technology. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 20 Years to 40 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGT-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.

DRUGR-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.


Locations(1)

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

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NCT06599528


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