A Phase 2 interventional study of STSP-0902 injection and Placebo in Oligozoospermia and/or Asthenozoospermia, sponsored by Staidson (Beijing) Biopharmaceuticals Co., Ltd. Not yet recruiting at 1 site in China. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Staidson (Beijing) Biopharmaceuticals Co., Ltd · Phase 2, Interventional, and Treatment
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.
32 studies on the registry are indexed under Asthenozoospermia; 9 are open to participants now.
This study's planned enrollment of 72 is above the median of 62 across 25 interventional studies indexed under Asthenozoospermia.
Browse Asthenozoospermia studies →Staidson (Beijing) Biopharmaceuticals Co., Ltd is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:.
A:1×10⁶/mL\<sperm concentration\<15×10⁶/mL, or total sperm number \< 39×10⁶. B:1% \<progressive motility sperm percentage (PR%) \<32%; If the test result shows sperm concentration\<5×10⁶/mL, Y chromosome microdeletion (AZF gene testing) abnormalities should be ruled out.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
24 subjects will be randomized to receive low dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort)
Drug: STSP-0902 injection · Drug: Placebo
24subjects will be randomized to receive middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort)
Drug: STSP-0902 injection · Drug: Placebo
24 subjects will be randomized to receive high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort)
Drug: STSP-0902 injection · Drug: Placebo
Subjects will receive the administration once weekly for sevral consecutive weeks
Subjects 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.
Time frame: 16weeks
sperm concentration
To evaluate the efficacy
Time frame: 12 weeks
sperm progressive motility (PR%)
To evaluate the efficacy
Time frame: 12weeks
Maximum Steady-State Concentration
To evaluate the pharmacokinetics (PK)
Time frame: 16 weeks
Minimum Steady-State Concentration Elimination
To evaluate the pharmacokinetics (PK)
Time frame: 16weeks
Accumulation Ratio
To evaluate the pharmacokinetics (PK)
Time frame: 16weeks
Steady-state elimination half-life time
To evaluate the pharmacokinetics (PK)
Time frame: 16weeks
anti-drug antibodies (ADA)
To evaluate the immunogenicity
Time frame: 16weeks
neutralizing antibodies (nAb)
To evaluate the immunogenicity
Time frame: 16weeks
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: STSP-0902
Staidson (Beijing) Biopharmaceuticals Co., Ltd →