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RECRUITING
NCT07313722
PHASE1

Study Evaluating Safety of BT01001 Ophthalmic Solution

Sponsor: Beyang Therapeutics Co., Ltd.

View on ClinicalTrials.gov

Summary

This Phase I study is designed to evaluate the safety, tolerability, and pharmacokinetic profile of BT01001 Ophthalmic Solution in healthy adult volunteers. The primary objectives are to assess the safety and tolerability of single and multiple ascending doses and to characterize the pharmacokinetics of BT01001 Ophthalmic Solution following topical ocular administration. This is a randomized, double-blind, placebo-controlled, dose-escalation trial consisting of four ascending dose cohorts. Each cohort will enroll eight participants, including six receiving BT01001 Ophthalmic Solution and 2 receiving Placebo.

Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single-center Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 0.5%, 1.0%, and 1.5% BT01001 Ophthalmic Solution in Healthy Adult Volunteers

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-11-17

Completion Date

2026-04

Last Updated

2026-01-02

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

BT01001 5 mg/ml(0.5%)

BT01001 Ophthalmic Solution will be administered as topical instillation into the right eye of each subject according to the assigned dosing schedule.

DRUG

BT01001 10 mg/ml(1.0%)

BT01001 Ophthalmic Solution will be administered as topical instillation into the right eye of each subject according to the assigned dosing schedule.

DRUG

BT01001 15 mg/ml(1.5%)

BT01001 Ophthalmic Solution will be administered as topical instillation into the right eye of each subject according to the assigned dosing schedule.

DRUG

Placebo

Placebo BT01001 Ophthalmic Solution will be administered as a topical instillation into the right eye of each subject following the same dosing schedule as the active treatment.

Locations (1)

Shanghai General Hospital

Shanghai, China