NCT06948799 A Study to Evaluate the Safety and Tolerability of Single and Multiple Dose of STSP-0902 in Healthy Subjects
| NCT ID | NCT06948799 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Staidson (Beijing) Biopharmaceuticals Co., Ltd |
| Condition | Oligozoospermia |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-05-08 |
| Primary Completion | 2026-05 |
Trial Parameters
Eligibility Fast-Check
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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
Eligibility Criteria
Inclusion Criteria: 1. 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. 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 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. 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 informed consent to this study before the study and voluntarily sign a written informed consent