A Phase I Clinical Trial to Compare the Pharmacokinetics, Safety and Immunogenicity of SJ04 and Ovidrel® in Healthy Female Subjects in China
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.
[Translation] Phase I clinical trial comparing the pharmacokinetics, safety and immunogenicity of SJ04 injection and Aize® in healthy Chinese female subjects
Primary objective
To evaluate the pharmacokinetic (PK) similarity between SJ04 injection and Aize® in healthy Chinese female subjects after a single subcutaneous injection.
Secondary objective
To evaluate the safety and immunogenicity of SJ04 injection and Aize® in healthy Chinese female subjects after a single subcutaneous injection.
[Translation] Phase II/III clinical trial of recombinant human follicle-stimulating hormone-CTP fusion protein injection in patients undergoing assisted reproductive technology (ART)
Phase II trial
Main purpose: To evaluate the preliminary efficacy of recombinant human follicle stimulating hormone-CTP fusion protein injection in patients undergoing ART, using the number of oocytes obtained as an indicator;
Secondary purpose: To evaluate the safety, efficacy, immunogenicity, and population pharmacokinetic characteristics of recombinant human follicle stimulating hormone-CTP fusion protein injection in patients undergoing ART.
Phase III trial
Main purpose: To evaluate the efficacy of recombinant human follicle stimulating hormone-CTP fusion protein injection in patients undergoing ART, using the number of oocytes obtained as an indicator;
Secondary purpose: To evaluate the safety, efficacy, and immunogenicity of recombinant human follicle stimulating hormone-CTP fusion protein injection in patients undergoing ART.
The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3
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