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ACTIVE NOT RECRUITING
NCT06597422
PHASE1

A Study of STSP-0902 Ophthalmic Solution in Healthy Subjects

Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-10-20

Completion Date

2025-05

Last Updated

2025-01-20

Healthy Volunteers

Yes

Interventions

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

Locations (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China