NCT07313722: Study Evaluating Safety of BT01001 Ophthalmic Solution

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.

Timeline

Start: 2025-11-17
Primary completion: 2026-02
Completion: 2026-04

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BT01001	Unknown	5 mg/ml	Topical
Subject	BT01001	Unknown	10 mg/ml	Topical
Subject	BT01001	Unknown	15 mg/ml	Topical

Indications

No indication recorded.