Study Evaluating Safety of BT01001 Ophthalmic Solution

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.

NCT Number	NCT07313722
Lead Sponsor	Beyang Therapeutics Co., Ltd.
Conditions	Healthy
Enrollment	32 participants
Start Date	2025-11-17
Primary Completion	2026-02 (estimated)
Study Completion	2026-04 (estimated)
Updated on ClinicalTrials.gov	2026-01-02