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

NCT06948799 | Recruiting Phase 1

• 1 other identifier: STSP-0902-01-002
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Oligozoospermia

Outcome Measures

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

  85 days in multiple dose phase and 28 days in single dose phase

Secondary Outcomes (7)

• Maximum Concentration (Cmax)

  From pre-dose up to 21 days post last dose

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

  From pre-dose up to 21 days post last dose

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

  From pre-dose up to 21 days post last dose

• Time to peak Concentration (Tmax)

  From pre-dose up to 21 days post last dose

• Elimination Phase Half-life (t1/2)

  From pre-dose up to 21 days post last dose

Other Outcomes (1)

• Tests for hormones

  85 days in multiple dose phase and 28 days in single dose phase

Study Arms (6)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

STSP-0902 injection DRUG

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

Higher dose Ⅰ of STSP-0902 sc injection or dose-matched placebo (First cohort in single dose phase); Higher dose Ⅱ of STSP-0902 sc injection or dose-matched placebo (Second cohort in single dose phase); high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort); higher dose of STSP-0902 subcutaneous injection or dose-matched placebo (fourth 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)

Placebo DRUG

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

Higher dose Ⅰ of STSP-0902 sc injection or dose-matched placebo (First cohort in single dose phase); Higher dose Ⅱ of STSP-0902 sc injection or dose-matched placebo (Second cohort in single dose phase); high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort); higher dose of STSP-0902 subcutaneous injection or dose-matched placebo (fourth 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)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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%.
• 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.
• Participants should avoid high temperature environments during the trial, including saunas, steam baths, hot baths, hot springs, and the use of electric blankets.
• Participants must give informed consent to this study before the study and voluntarily sign a written informed consent form.

You may not qualify if:

• 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.
• Participants who have undergone any major surgery within 3 months prior to screening or have surgery planned during the trial period.
• Participants who have experienced a fever exceeding 38 ℃ within 1 month prior to screening
• 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.
• 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.
• Participants 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.
• Participants who have smoked more than 5 cigarettes per day or an equivalent amount of tobacco in the 3 months prior to screening.
• 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.
• 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.
• Participants who have a history of drug abuse within 1 year prior to screening or have a positive urine drug test.
• 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.
• 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.

Sponsors & Collaborators

• Staidson (Beijing) Biopharmaceuticals Co., Ltd: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Oligospermia

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Kai Hong, Ph.D

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bi

CONTACT

+8613130207522; bicui@staidson.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 29, 2025
• Study Start: May 8, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CN (1)