drugset / Trial / NCT06597422

A Study of STSP-0902 Ophthalmic Solution in Healthy Subjects

NCT06597422 ↗

Phase 1 Completed 82 enrolled Staidson (Beijing) Biopharmaceuticals Co., Ltd
RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start
2024-10-20
Primary completion
2025-01-23
Completion
2025-01-23

Drugs

EvaluationDrugModalityDoseRoute
Subject STSP-0902 Unknown — Other