NCT07833943尚未招募2 期
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
Staidson (Beijing) Biopharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
- •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.
研究组 & 干预措施
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)
干预措施: STSP-0902 injection (Drug)
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)
干预措施: Placebo (Drug)
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)
干预措施: STSP-0902 injection (Drug)
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)
干预措施: Placebo (Drug)
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)
干预措施: STSP-0902 injection (Drug)
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)
干预措施: Placebo (Drug)
结局指标
主要结局
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.
时间窗: 16weeks
次要结局
- anti-drug antibodies (ADA)(16weeks)
- sperm concentration(12 weeks)
- sperm progressive motility (PR%)(12weeks)
- Maximum Steady-State Concentration(16 weeks)
- Minimum Steady-State Concentration Elimination(16weeks)
- Accumulation Ratio(16weeks)
- Steady-state elimination half-life time(16weeks)
- neutralizing antibodies (nAb)(16weeks)
研究者
研究点 (1)
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