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CompletedNCT06563713Updated May 11, 2025

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of STSP-0902 in Healthy Subjects

A Phase 1 interventional study of STSP-0902 injection and Placebo in Oligozoospermia and Asthenozoospermia, sponsored by Staidson (Beijing) Biopharmaceuticals Co., Ltd. Completed at 1 site in China. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-11.

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

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Oligozoospermia
  • Asthenozoospermia
03

In context

Oligospermia

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

This study's enrollment of 40 is below 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. Healthy 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, and whose routine semen analysis results during the screening period meet the criteria of a total sperm count of less than 180 million (or a sperm concentration of less than 63 million) or a percentage of progressively motility sperm of less than 56%.
  2. 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.
  3. Subjects 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. Subjects who have undergone any major surgery within 3 months prior to screening or have surgery planned during the trial period.
  5. 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.
  6. Subjects 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.
  7. Subjects who are positive for any one of the surface antigen, antibody, treponema pallidum antibody, and antigen/antibody combination test (primary screening).
  8. Tattoos at the injection site or other skin conditions that interfere with observation of the skin.
  9. Subjects who have smoked more than 5 cigarettes per day or an equivalent amount of tobacco in the 3 months prior to screening.
  10. Subjects 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.
  11. Subjects 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.
  12. Subjects who have a history of drug abuse within 1 year prior to screening or have a positive urine drug test.
  13. Subjects 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.
  14. Subjects who have taken any product or participated in any clinical trial of drug, devices or vaccines intervention within 3 months prior to screening.
  15. 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.
  16. Subjects who have used any prescription, over-the-counter medications or herbal remedies within 14 days prior to screening.
  17. Subjects with a history of fear of needles and homophobia.
  18. Subjects 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
40 participants (actual)

Study arms

  • Experimental
    lowest dose group

    8 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
    low dose group

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

    Drug: STSP-0902 injection · Drug: Placebo

  • Experimental
    middle dose group

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

    Drug: STSP-0902 injection · Drug: Placebo

  • Experimental
    high dose group

    Experimental: 8 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
    highest dose group

    Experimental: 8 subjects will be randomized to receive highest dose of STSP-0902 subcutaneous injection or dose-matched placebo (Fifth cohort)

    Drug: STSP-0902 injection · Drug: Placebo

Interventions

  • Subjects will receive the administration dose on Day 0 following protocol requirements

  • DrugPlacebo

    Subjects will receive the administration dose on Day 0 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: 28 days

Secondary outcomes

  1. Maximum Concentration (Cmax)

    To evaluate the pharmacokinetics (PK) of STSP-0902

    Time frame: Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days

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

    To evaluate the pharmacokinetics (PK) of STSP-0902

    Time frame: Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days

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

    To evaluate the pharmacokinetics (PK) of STSP-0902

    Time frame: Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days

  4. Time to peak Concentration (Tmax)

    To evaluate the pharmacokinetics (PK) of STSP-0902

    Time frame: Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days

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

    To evaluate the pharmacokinetics (PK) of STSP-0902

    Time frame: Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days

  6. apparent oral clearance (CL/F)

    To evaluate the pharmacokinetics (PK) of STSP-0902

    Time frame: Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days

  7. Anti-drug antibody(ADA)

    To evaluate the immunogenicity of STSP-0902

    Time frame: Pre-dose; after dose: 336 hours, 28 days

07

Study locations

1 site
  • Peking University Third Hospital
    Beijing, Beijing 100191, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06563713
Responsible party
Sponsor
First posted
Aug 21, 2024
Start date
Jul 31, 2024
Primary completion
Feb 24, 2025
Completion
Feb 24, 2025
Last update
May 11, 2025

Study contacts

Kai Hong, Doctor
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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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: STSP-0902

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