OligozoospermiaPhase 1NCT06563713
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of STSP-0902 in Healthy Subjects
A Phase 1 study testing STSP-0902 injection in people with Oligozoospermia and Asthenozoospermia, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oligozoospermia, 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
- 40 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2024to 24 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers, aged between 18 and 50 years inclusive, with a body weight of at least 50.0 kg, and a body mass index (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%.
- Participants (including the partners of the participants) must use effective non-drug contraceptive measures during the trial period and for four months after the end of administration, and must not have plans for pregnancy or sperm donation.
- Subjects must give informed consent to this study before the study and voluntarily sign a written informed consent form.
Who cannot join
- 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.
- 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.
- 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.
- Subjects who have undergone any major surgery within 3 months prior to screening or have surgery planned during the trial period.
- Pre-enrollment physical examination, electrocardiogram, vital signs, laboratory tests, and results of all tests related to the trial (except oligoasthenzoospermia), with abnormalities judged clinically significant by the investigator.
- 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.
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- Subjects who are positive for any one of the hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, and HIV antigen/antibody combination test (primary screening).
- Tattoos at the injection site or other skin conditions that interfere with observation of the skin.
- Subjects who have smoked more than 5 cigarettes per day or an equivalent amount of tobacco in the 3 months prior to screening.
- 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.
- 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.
- Subjects who have a history of drug abuse within 1 year prior to screening or have a positive urine drug test.
- 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.
- Subjects who have taken any investigational product or participated in any clinical trial of drug, devices or vaccines intervention within 3 months prior to screening.
- 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.
- Subjects who have used any prescription, over-the-counter medications or herbal remedies within 14 days prior to screening.
- Subjects with a history of fear of needles and homophobia.
- Subjects 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.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Immunogenicity of STSP-0902 in Healthy Subjects
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.
- Conditions
- Oligozoospermia, Asthenozoospermia
- Being tested
- STSP-0902 injection, Placebo
- Medical subject headings
- Oligospermia, Asthenozoospermia
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 dose on Day 0 following protocol requirements
PlaceboDrug
Subjects will receive the administration dose on Day 0 following protocol requirements
| Study group | Role | What they receive |
|---|---|---|
| lowest dose group | Experimental | 8 subjects will be randomized to receive lowest dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort) Receives: Drug: STSP-0902 injection; Drug: Placebo |
| low dose group | Experimental | 8 subjects will be randomized to receive low dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort) Receives: Drug: STSP-0902 injection; Drug: Placebo |
| middle dose group | Experimental | 8 subjects will be randomized to receive middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort) Receives: Drug: STSP-0902 injection; Drug: Placebo |
| high dose group | Experimental | Experimental: 8 subjects will be randomized to receive high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Fourth cohort) Receives: Drug: STSP-0902 injection; Drug: Placebo |
| highest dose group | Experimental | Experimental: 8 subjects will be randomized to receive highest dose of STSP-0902 subcutaneous injection or dose-matched placebo (Fifth 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 5.0
To evaluate the safety and tolerability of STSP-0902 injection in healthy adult subjects
Measured: 28 days
Secondary outcomes (7)
Maximum Concentration (Cmax)
To evaluate the pharmacokinetics (PK) of STSP-0902
Measured: 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
Area under the plasma concentration-time curve (AUC0-t)
To evaluate the pharmacokinetics (PK) of STSP-0902
Measured: 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
Area under the curve from time 0 extrapolated to infinite time (AUC0-∞)
To evaluate the pharmacokinetics (PK) of STSP-0902
Measured: 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
Time to peak Concentration (Tmax)
To evaluate the pharmacokinetics (PK) of STSP-0902
Measured: 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
Elimination Phase Half-life (t1/2)
To evaluate the pharmacokinetics (PK) of STSP-0902
Measured: 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
apparent oral clearance (CL/F)
To evaluate the pharmacokinetics (PK) of STSP-0902
Measured: 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
Anti-drug antibody(ADA)
To evaluate the immunogenicity of STSP-0902
Measured: Pre-dose; after dose: 336 hours, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start31 Jul 2024
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligozoospermiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kai Hong, Doctor, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563713
- Sponsor's protocol ID
- STSP-0902-01-001
- Status last verified
- Mar 2025
- First submitted
- 2 Jul 2024
- Last updated
- 11 May 2025
- 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 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Immunogenicity of STSP-0902 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06563713
- Acronym / sponsor ID
- STSP-0902-01-001
- Conditions
- Oligozoospermia, Asthenozoospermia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 21 Aug 2024 (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 1a, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of STSP-0902.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| lowest dose group | Experimental | Drug: STSP-0902 injection, Drug: Placebo8 subjects will be randomized to receive lowest dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort) |
| low dose group | Experimental | Drug: STSP-0902 injection, Drug: Placebo8 subjects will be randomized to receive low dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort) |
| middle dose group | Experimental | Drug: STSP-0902 injection, Drug: Placebo8 subjects will be randomized to receive middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort) |
| high dose group | Experimental | Drug: STSP-0902 injection, Drug: PlaceboExperimental: 8 subjects will be randomized to receive high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Fourth cohort) |
| highest dose group | Experimental | Drug: STSP-0902 injection, Drug: PlaceboExperimental: 8 subjects will be randomized to receive highest dose of STSP-0902 subcutaneous injection or dose-matched placebo (Fifth cohort) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteers, aged between 18 and 50 years inclusive, with a body weight of at least 50.0 kg, and a body mass index (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%.
- Participants (including the partners of the participants) must use effective non-drug contraceptive measures during the trial period and for four months after the end of administration, and must not have plans for pregnancy or sperm donation.
- Subjects must give informed consent to this study before the study and voluntarily sign a written informed consent form.
Key exclusion criteria (18 listed)
- 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.
- 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.
- 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.
- Subjects who have undergone any major surgery within 3 months prior to screening or have surgery planned during the trial period.
- Pre-enrollment physical examination, electrocardiogram, vital signs, laboratory tests, and results of all tests related to the trial (except oligoasthenzoospermia), with abnormalities judged clinically significant by the investigator.
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 dose on Day 0 following protocol requirements | Drug | high dose group, highest dose group, low dose group, lowest dose group, middle dose group |
| PlaceboSubjects will receive the administration dose on Day 0 following protocol requirements | Drug | high dose group, highest dose group, low dose group, lowest dose group, middle dose group |
Primary outcome
Number of treatment-related adverse events as assessed by CTCAE 5.0
Time frame: 28 days
To evaluate the safety and tolerability of STSP-0902 injection in healthy adult subjects
7 secondary outcomes
Maximum Concentration (Cmax)
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
Area under the plasma concentration-time curve (AUC0-t)
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
Area under the curve from time 0 extrapolated to infinite time (AUC0-∞)
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
Time to peak Concentration (Tmax)
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
Elimination Phase Half-life (t1/2)
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
apparent oral clearance (CL/F)
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
Anti-drug antibody(ADA)
Time frame: Pre-dose; after dose: 336 hours, 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
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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. This study is not recruiting at the moment.
Kai Hong, Doctor 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 1 study testing STSP-0902 injection in people with Oligozoospermia and 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 3 inclusion and 18 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: finished, as of the sponsor's last update on 11 May 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment-related adverse events as assessed by CTCAE 5.0 (time frame: 28 days). 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 11 May 2025.