NCT06948799

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

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Immunogenicity of STSP-0902 in Healthy Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1b, randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of STSP-0902

Conditions

• Oligozoospermia

Interventions

Type	Name	Description
DRUG	STSP-0902 injection	Subjects will receive the administration dose on Day 1 following protocol requirements
DRUG	Placebo	Subjects will receive the administration dose on Day 1 following protocol requirements

Timeline

• Start date: 2025-05-08
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2025-04-29
• Last updated: 2025-09-12

Locations

1 site across 1 country: China