Oligozoospermia and/or AsthenozoospermiaPhase 2NCT07833943
A Study to Evaluate the Safety and Efficacy of Multiple Dose of STSP-0902 in Patients With Oligozoospermia and/or Asthenozoospermia.
A Phase 2 study testing STSP-0902 injection in people with Oligozoospermia and/or Asthenozoospermia, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Oligozoospermia and/or Asthenozoospermia
- What is being tested?
- STSP-0902 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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:.
- 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.
- 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.
Who cannot join
- 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.
- Screen for participants who have received treatment affecting spermatogenic function within the previous month or are scheduled to receive such treatment during the trial period.
- Screen for participants with a history of treatment with nerve growth factor-related drugs within the previous month (e.g. Mouse Nerve Growth Factor for Injection).
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- Participants who have undergone any major surgery within 3 months prior to screening or have surgery planned during the trial period.
- Participants who are allergic to any NGF or who, in the judgment of the investigator, are at risk of allergy as a result of participation in the study.
- Participants with a positive result for either human immunodeficiency virus antibody (anti-human immunodeficiency virus antibody, HIV-Ab) or treponema pallidum-specific serum antibody (anti-treponema pallidum antibody, TPAb).
- Diagnosed with malignant tumor or recently received long term radiotherapy.
- Diagnosed with a mental illness.
- Participants who have taken any investigational product or participated in any clinical trial of drug, devices or vaccines intervention within 3 months prior to screening.
- Participants with other factors that are not suitable for participation in this study as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Kai Hong, 010-82266226, kenhong99@hotmail.com
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, and Multiple Dose Study to Evaluate the Safety, Efficacy, Pharmacokinetic, and Immunogenicity of STSP-0902 in Patients With Oligozoospermia and/or Asthenozoospermia
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.
- Conditions
- Oligozoospermia and/or Asthenozoospermia
- Being tested
- STSP-0902 injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STSP-0902 injectionDrug
Subjects will receive the administration once weekly for sevral consecutive weeks
PlaceboDrug
Subjects will receive the administration once weekly for sevral consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| low dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort) | Experimental | 24 subjects will be randomized to receive low dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort) Receives: Drug: STSP-0902 injection; Drug: Placebo |
| middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort) | Experimental | 24subjects will be randomized to receive middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort) Receives: Drug: STSP-0902 injection; Drug: Placebo |
| high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort) | Experimental | 24 subjects will be randomized to receive high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort) Receives: Drug: STSP-0902 injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16weeks
Secondary outcomes (8)
sperm concentration
To evaluate the efficacy
Measured: 12 weeks
sperm progressive motility (PR%)
To evaluate the efficacy
Measured: 12weeks
Maximum Steady-State Concentration
To evaluate the pharmacokinetics (PK)
Measured: 16 weeks
Minimum Steady-State Concentration Elimination
To evaluate the pharmacokinetics (PK)
Measured: 16weeks
Accumulation Ratio
To evaluate the pharmacokinetics (PK)
Measured: 16weeks
Steady-state elimination half-life time
To evaluate the pharmacokinetics (PK)
Measured: 16weeks
anti-drug antibodies (ADA)
To evaluate the immunogenicity
Measured: 16weeks
neutralizing antibodies (nAb)
To evaluate the immunogenicity
Measured: 16weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligozoospermia and/or AsthenozoospermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kai Hong, Ph.D, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833943
- Sponsor's protocol ID
- STSP-0902-01-003
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, and Multiple Dose Study to Evaluate the Safety, Efficacy, Pharmacokinetic, and Immunogenicity of STSP-0902 in Patients With Oligozoospermia and/or Asthenozoospermia
- ClinicalTrials.gov ID
- NCT07833943
- Acronym / sponsor ID
- STSP-0902-01-003
- Conditions
- Oligozoospermia and/or Asthenozoospermia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort) | Experimental | Drug: STSP-0902 injection, Drug: Placebo24 subjects will be randomized to receive low dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort) |
| middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort) | Experimental | Drug: STSP-0902 injection, Drug: Placebo24subjects will be randomized to receive middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort) |
| high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort) | Experimental | Drug: STSP-0902 injection, Drug: Placebo24 subjects will be randomized to receive high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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:.
- 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.
- 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.
Key exclusion criteria (13 listed)
- 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.
- Screen for participants who have received treatment affecting spermatogenic function within the previous month or are scheduled to receive such treatment during the trial period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STSP-0902 injectionSubjects will receive the administration once weekly for sevral consecutive weeks | Drug | high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort), low dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort), middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort) |
| PlaceboSubjects will receive the administration once weekly for sevral consecutive weeks | Drug | high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort), low dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort), middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort) |
Primary outcome
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
8 secondary outcomes
sperm concentration
Time frame: 12 weeks
sperm progressive motility (PR%)
Time frame: 12weeks
Maximum Steady-State Concentration
Time frame: 16 weeks
Minimum Steady-State Concentration Elimination
Time frame: 16weeks
Accumulation Ratio
Time frame: 16weeks
Steady-state elimination half-life time
Time frame: 16weeks
anti-drug antibodies (ADA)
Time frame: 16weeks
neutralizing antibodies (nAb)
Time frame: 16weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kai Hong, Ph.D principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STSP-0902 injection in people with Oligozoospermia and/or Asthenozoospermia, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cui Bi (+86 010-67519614, bicui@staidson.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.