NCT07313722

Study Evaluating Safety of BT01001 Ophthalmic Solution

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Beyang Therapeutics Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-17
• Primary completion: 2026-02-01
• Completion: 2026-04-01
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study