Actively Recruiting

Phase 1
Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT07313722

Study Evaluating Safety of BT01001 Ophthalmic Solution

Led by Beyang Therapeutics Co., Ltd. · Updated on 2026-01-02

32

Participants Needed

1

Research Sites

19 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Study Evaluating Safety of BT01001 Ophthalmic Solution

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy male or female aged 18 to 50 years with good health based on medical history, exams, vital signs, ECG, and lab tests
  • Body Mass Index between 18.0 and 27.0 kg/m8
  • Negative alcohol breath test and urine drug screen at screening
  • Willing and able to follow study procedures and communicate with staff
  • Female participants of childbearing potential must have a negative pregnancy test at screening and agree to abstain or use contraception until 90 days after last dose
  • Ability to understand the study and sign informed consent
  • Corrected vision acuity 65 0.8 in both eyes
  • Intraocular pressure less than 21 mmHg in each eye and less than 4 mmHg difference between eyes
  • Normal or non-clinically significant findings on slit-lamp and ophthalmoscopic exams
Not Eligible

You will not qualify if you...

  • Known or suspected allergy to any study drug component or history of multiple allergies
  • History or presence of significant diseases or abnormalities including cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, dermatologic, oncologic, hematologic, immunologic, infectious, neurologic, psychiatric, or any condition interfering with study
  • Participation in other investigational drug or device trials within 90 days prior
  • Use of prescription or over-the-counter drugs within 14 days prior or unwillingness to stop during study
  • Systemic corticosteroid use within 6 months prior
  • History of alcohol or substance abuse within 2 years
  • Smoking 5 or more cigarettes per day within 12 weeks prior or unwillingness to abstain during study
  • Average alcohol intake over 14 units per week within 12 weeks prior
  • History or evidence of intravenous drug use or positive tests for HIV, HCV, hepatitis B, or syphilis at screening
  • Blood donation or receipt within 30 days prior
  • History of bleeding or coagulation disorders
  • Significant abnormalities on physical exam, vital signs, ECG, or labs at screening
  • Current or past use of bariatric medications or surgery
  • Impaired mental status or other factors affecting adherence
  • Any condition judged by investigator to interfere with study or pose risks
  • History of eye surgery, trauma, or chronic eye disease
  • Use of contact lenses within 2 weeks prior to dosing
  • Clinically significant eye abnormalities or symptoms
  • Use of intraocular injectable, implantable, or topical ophthalmic medications within 2 months prior or expected need during study
  • Eye infection, inflammation, blepharitis, conjunctivitis within 2 months or history of herpes simplex keratitis
  • Significant findings on eye exams that may affect safety evaluations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai General Hospital

Shanghai, China, 200080

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

14

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