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

StatusRecruiting
PhasePhase 1
Started
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Record status
This record was last updated May 22, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion pushed from May 2026 to Jul 2026
    • Study completion pushed from May 2026 to Aug 2026
    v6
  2. Enrollment target: 48 to 64v5 Show 5 more changesShow less
    • Primary and study completion dates: Feb 2026 to May 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Study arms: 4 to 6
    • Study title expanded, about 2 words
  3. Enrollment target: 36 to 48
    • Primary and study completion dates: Nov 2025 to Feb 2026
    • Study arms: 3 to 4
    v4
  4. Re-verified, no change to tracked fieldsv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2025 to May 8, 2025
    • Site details revised
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06948799
Lead Sponsor Staidson (Beijing) Biopharmaceuticals Co., Ltd
Conditions
(from sponsor)		 Oligozoospermia
Related terms Oligospermia
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov