Suzhou Kangju BIOTECHNOLOGY Co., Ltd.

Primary objective: To evaluate the pharmacodynamic characteristics of recombinant human hyaluronidase for injection as an adjunct to subcutaneous infusion in healthy subjects. Secondary objective: To evaluate the pharmacodynamic characteristics, safety, and immunogenicity of recombinant human hyaluronidase for injection in healthy subjects.

Primary purpose: To evaluate the pharmacodynamic characteristics of a single self-controlled subcutaneous infusion of recombinant human hyaluronidase for injection in healthy subjects, using the rate of subcutaneous infusion as an indicator; Secondary purpose: To evaluate the pharmacodynamic characteristics of a single self-controlled subcutaneous infusion of recombinant human hyaluronidase for injection in healthy subjects, using the measured arm circumference of the subjects as an indicator; Evaluate the safety and immunogenicity of a single self-controlled subcutaneous infusion of recombinant human hyaluronidase for injection in healthy subjects.

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.