This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of STSP-0902 in Patients with Oligozoospermia and/or Asthenozoospermia.
Male volunteers, aged between 18 and 50 years
Referring to the WHO 5th edition manual, the patient is diagnosed with oligozoospermia, asthenozoospermia, or oligo asthenozoospermia, and both routine semen analysis test results during the screening period meet Criterion A and/or Criterion B:.
Participants (including their partners) must use effective non pharmacological contraceptive measures and have no plans for conception or sperm donation from the time of signing the informed consent form until one month after the end of the last drug administration.
Participants shall complete semen collection in accordance with the study protocol, have fully understood the study content, procedures and potential adverse reactions, and voluntarily sign the informed consent form.
Oligospermia and/or asthenospermia with identifiable etiologies, such as reproductive system infectious diseases, genital trauma, inguinal or genital surgery, severe varicocele (Grade III), cryptorchidism, genital tract obstruction, genetic factors, related endocrine disorders(e.g, Hypogonadotropic hypogonadism , uncontrolled diabetes mellitus), pituitary diseases, post-radiotherapy and chemotherapy status, exposure to reproductive-toxic drugs, immune factors, etc.
The presence of diseases without effective control or that may lead to hospitalization during screening may significantly increase the safety risks for trial participants or interfere with the interpretation of study results.
Screening-phase follicle-stimulating hormone (FSH) result ≥8 IU/L.
Participants who have experienced a fever exceeding 38.5℃ occurred within 1 month before administration.
Sequential
STSP-0902 injection
DrugSubjects will receive the administration once weekly for sevral consecutive weeks
Placebo
DrugSubjects will receive the administration once weekly for sevral consecutive weeks
Number of treatment-related adverse events as assessed by CTCAE 6.0. To evaluate the safety and tolerability of STSP-0902 injection in Patients with Oligozoospermia and/or Asthenozoospermia.
sperm concentration
To evaluate the efficacy
sperm progressive motility (PR%)
To evaluate the efficacy
Maximum Steady-State Concentration
To evaluate the pharmacokinetics (PK)
Minimum Steady-State Concentration Elimination
To evaluate the pharmacokinetics (PK)
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This trial is not recruiting at the moment. You can still explore other options:
