NCT06563713

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of STSP-0902 in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Oligozoospermia
• Asthenozoospermia

Interventions

Type	Name	Description
DRUG	STSP-0902 injection	Subjects will receive the administration dose on Day 0 following protocol requirements
DRUG	Placebo	Subjects will receive the administration dose on Day 0 following protocol requirements

Timeline

• Start date: 2024-07-31
• Primary completion: 2025-02-24
• Completion: 2025-02-24
• First posted: 2024-08-21
• Last updated: 2025-05-11

Locations

1 site across 1 country: China