Study Evaluating Safety of BT01001 Ophthalmic Solution
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: \- General Inclusion Criteria: 1. Healthy male or female participant, 18 to 50 years of age at the time of screening, who are in good health based on medical history, physical examinations, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations. 2. Body Mass Index (BMI) between 18.0 and 27.0 kg/m² (inclusive). 3. Negative alcohol breath test and negative urine drug screen at screening. 4. Willing and able to comply with all study procedure and capable of good communication with study personnel. 5. Participants of childbearing potential must agree to abstain from sexual intercourse or use an effective method of contraception from screening until 90 days after the final study drug administration; Female participants of childbearing potential must have a negative urine pregnancy test at screening. 6. Able to understand the study procedure and voluntarily sign the written informed consent form. Ophthalmology Inclusion Criteria: 7. Corrected vision acu