NCT06597422

A Study of STSP-0902 Ophthalmic Solution in Healthy Subjects

A Phase I, Single and Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STSP-0902 Ophthalmic Solution in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This trial is a Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of STSP-0902 ophthalmic solution in healthy subjects following single and multiple administrations. The study plans to enroll 80 healthy subjects and is divided into three stages: the single-dose study stage, the multiple-dose study stage, and the tear PK study stage. The single-dose and multiple-dose study stages are randomized, double-blind, placebo-controlled, dose-escalation designs, while the tear PK study stage is a single-dose, open-label design.

Conditions

• Neurotrophic Keratitis

Interventions

Type	Name	Description
DRUG	STSP-0902 ophthalmic solution	Eye drop, single dose
DRUG	STSP-0902 Placebo	Eye drop, single dose
DRUG	STSP-0902 ophthalmic solution	Eye drop, three times daily for a total of 8 days
DRUG	STSP-0902 ophthalmic solution	Eye drop, six times daily for a total of 8 days
DRUG	STSP-0902 Placebo	Eye drop, multiple doses
DRUG	STSP-0902 ophthalmic solution	Eye drop, single dose, tear samples will be collected

Timeline

• Start date: 2024-10-20
• Primary completion: 2025-01-23
• Completion: 2025-01-23
• First posted: 2024-09-19
• Last updated: 2026-04-13

Locations

1 site across 1 country: China