ClinicalTrials.gg
RecruitingNCT06948799Updated May 22, 2026

A Study to Evaluate the Safety and Tolerability of Single and Multiple Dose of STSP-0902 in Healthy Subjects

A Phase 1 interventional study of STSP-0902 injection and Placebo in Oligozoospermia, sponsored by Staidson (Beijing) Biopharmaceuticals Co., Ltd. Recruiting at 1 site in China. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Staidson (Beijing) Biopharmaceuticals Co., Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started May 2025; still recruiting 1 year 6 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

This is a Phase 1b, randomized, double-blind, placebo-controlled, single and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of STSP-0902

02

Conditions studied

  • Oligozoospermia

Browse trials for

03

In context

Oligospermia

64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.

This study's planned enrollment of 64 is close to the median of 65 across 46 interventional studies indexed under Oligospermia.

Browse Oligospermia studies →

Lead sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd is the lead sponsor of 28 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  1. Male volunteers, aged between 18 and 50 years inclusive, with a body weight of at least 50.0 kg, and a (BMI) between 19.0 and 28.0 kg/m² inclusive.
  2. Participants in the multiple dose phase must meet one of the following criteria: two routine semen analysis results during the screening period meet the criteria of sperm concentration of less than 15 million and/or percentage of progressively motility sperm of less than 32%.
  3. Participants (including the partners of the participants) must use effective non-drug measures during the trial period and for four months after the end of administration, and must not have plans for pregnancy or sperm donation.
  4. Participants should avoid high temperature environments during the trial, including saunas, steam baths, hot baths, hot springs, and the use of electric blankets.
  5. Participants must give to this study before the study and voluntarily sign a written informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Participants with a history of severe diseases, including but not limited to conditions affecting the skeletal, neuropsychiatric, cardiovascular, hematologic, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immune, and reproductive systems (such as reproductive system infectious diseases, varicocele, reproductive tract obstruction, etc., except for oligoasthenzoospermia), as judged by the investigator, may endanger the safety of the participant or affect the study results.
  2. Participants who have planned to receive treatments related to oligoasthenzoospermia, such as zinc sulfate, levocarnitine, escin, or pancreatic kallikrein, within 3 months prior to screening or during the trial period.
  3. Participants with a history of treatment with nerve growth factor-like drug therapy (such as mouse nerve growth factor for injection) within 3 months prior to screening.
  4. Participants who have undergone any major surgery within 3 months prior to screening or have surgery planned during the trial period.
  5. Participants who have experienced a fever exceeding 38 ℃ within 1 month prior to screening
  6. Pre-enrollment physical examination, , vital signs, laboratory tests, and results of all tests related to the trial (except oligoasthenzoospermia), with abnormalities judged by the investigator.
  7. Participants who are allergic to any component of the experimental drug or biological agent, or who, in the judgment of the investigator, are at risk of allergy as a result of participation in the study.
  8. Participants who are positive for any one of the surface antigen, antibody, treponema pallidum antibody, and antigen/antibody combination test (primary screening).
  9. Tattoos at the injection site or other skin conditions that interfere with observation of the skin.
  10. Participants who have smoked more than 5 cigarettes per day or an equivalent amount of tobacco in the 3 months prior to screening.
  11. Participants with frequent alcohol consumption within 6 months prior to screening, i.e., more than 2 units of alcohol per day (1 unit = 360 ml of beer or 45 ml of spirits of 40% alcohol by volume or 150 ml of wine); or those with a positive alcohol breath test.
  12. Participants who have habitual consumption of more than 5 cups of coffee, tea or cola, etc. per day (150 ml and above per cup) in the 3 months prior to screening.
  13. Participants who have a history of drug abuse within 1 year prior to screening or have a positive urine drug test.
  14. Participants who have participated in blood donation within 3 months prior to screening with a total blood donation of ≥ 400 mL or total blood loss of ≥ 400 mL, or who have history of blood transfusion within 4 weeks prior to enrollment.
  15. Participants who have taken any product or participated in any clinical trial of drug, devices or vaccines intervention within 3 months prior to screening.
  16. Vaccination within 1 month prior to screening or scheduled to be administered during the study period up to 2 months after completion of the study.
  17. Participants who have used any prescription, over-the-counter medications or herbal remedies within 14 days prior to screening.
  18. Participants with a history of fear of needles and homophobia.
  19. Participants with other factors that are not suitable for participation in this study as judged by the investigator.
Terms in these criteria, in plain language(9)

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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

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.

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.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

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.

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    low dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort)

    12 subjects will be randomized to receive lowest dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort)

    Drug: STSP-0902 injection · Drug: Placebo

  • Experimental
    middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort)

    12 subjects will be randomized to receive middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort)

    Drug: STSP-0902 injection · Drug: Placebo

  • Experimental
    high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort)

    12 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

  • Experimental
    higher dose of STSP-0902 subcutaneous injection or dose-matched placebo (fourth cohort)

    12 subjects will be randomized to receive high dose of STSP-0902 subcutaneous injection or dose-matched placebo (fourth cohort)

    Drug: STSP-0902 injection · Drug: Placebo

  • Experimental
    Higher dose Ⅰ of STSP-0902 sc injection or dose-matched placebo (First cohort in single dose phase)

    8 subjects will be randomized to receive high dose Ⅰ of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort in single dose phase)

    Drug: STSP-0902 injection · Drug: Placebo

  • Experimental
    Higher dose Ⅱ of STSP-0902 sc injection or dose-matched placebo (Second cohort in single dose phase)

    8 subjects will be randomized to receive high dose Ⅱ of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort in single dose phase)

    Drug: STSP-0902 injection · Drug: Placebo

Interventions

  • Subjects will receive the administration dose on Day 1 following protocol requirements

  • DrugPlacebo

    Subjects will receive the administration dose on Day 1 following protocol requirements

06

What researchers measure

Primary outcomes

  1. Number of treatment-related adverse events as assessed by CTCAE 5.0.

    To evaluate the safety and tolerability of STSP-0902 injection in healthy adult subjects

    Time frame: 85 days in multiple dose phase and 28 days in single dose phase

Secondary outcomes

  1. Maximum Concentration (Cmax)

    To evaluate the pharmacokinetics (PK) of STSP-0902

    Time frame: From pre-dose up to 21 days post last dose

  2. Area under the plasma concentration-time curve (AUC0-t)

    To evaluate the pharmacokinetics (PK) of STSP-0902

    Time frame: From pre-dose up to 21 days post last dose

  3. Area under the curve from time 0 extrapolated to infinite time (AUC0-∞)

    To evaluate the pharmacokinetics (PK) of STSP-0902

    Time frame: From pre-dose up to 21 days post last dose

  4. Time to peak Concentration (Tmax)

    To evaluate the pharmacokinetics (PK) of STSP-0902

    Time frame: From pre-dose up to 21 days post last dose

  5. Elimination Phase Half-life (t1/2)

    To evaluate the pharmacokinetics (PK) of STSP-0902

    Time frame: From pre-dose up to 21 days post last dose

  6. apparent oral clearance (CL/F)

    To evaluate the pharmacokinetics (PK) of STSP-0902

    Time frame: From pre-dose up to 21 days post last dose in multiple dose phase and 28 days in single dose phase.

  7. Anti-drug antibody(ADA)

    To evaluate the immunogenicity of STSP-0902

    Time frame: From pre-dose up to 56 days post last dose in multiple dose phase and 28 days in single dose phase

Other outcomes

  1. Tests for hormones

    Time frame: 85 days in multiple dose phase and 28 days in single dose phase

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2025 (actual). Primary completion is estimated for Jul 2026, 14 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 21, 2025
First posted
Apr 29, 2025
StartActual
May 8, 2025
Primary completionEst.
Jul 2026
CompletionEst.
Aug 2026
Last update
May 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06948799
Responsible party
Sponsor
First posted
Apr 29, 2025
Start date
May 8, 2025
Primary completion
Jul 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
May 22, 2026

Study contacts

Bi
Contact
bicui@staidson.com
+8613130207522
Kai Hong, Ph.D
principal investigator · Peking University Third Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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