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A Study of STSP-0902 Ophthalmic Solution in Healthy Subjects

NCT06597422 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-04-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Staidson (Beijing) Biopharmaceuticals Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Laichun Lu, Ph.D · Beijing Tongren Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06597422 on ClinicalTrials.gov