Safety of BT01001 eye drops in healthy adults

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

This Phase I trial will test whether different doses of BT01001 eye drops are safe and how the body handles them in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Beyang Therapeutics Co., Ltd. (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07313722 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled, dose-escalation Phase I trial will enroll healthy adult volunteers to receive single and multiple topical ocular doses of BT01001 or placebo. There are four ascending dose cohorts, each with eight participants (six active, two placebo), to characterize safety, tolerability, and pharmacokinetics. Participants will undergo clinical exams, vital sign monitoring, ECGs, lab tests, and ocular assessments before and after dosing. Safety and PK data will guide whether the compound can advance to patient studies.

Who should consider this trial

Good fit: Healthy adults aged 18 to 50 years with BMI 18.0–27.0 kg/m², in good general and ocular health, willing to comply with study procedures and contraception requirements if applicable.

Not a fit: People with active eye disease, significant medical conditions, abnormal screening labs, BMI outside the allowed range, or who are pregnant or breastfeeding would likely not benefit and are excluded.

Why it matters

Potential benefit: If shown to be safe and well tolerated, this could enable development of a new topical eye medication for future patient trials.

How similar studies have performed: Randomized, double-blind, placebo-controlled Phase I dose-escalation trials of ophthalmic solutions are a standard approach and have previously enabled safe compounds to progress to later-phase trials.

Eligibility criteria

Inclusion Criteria:

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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 acuity ≥ 0.8 in both eyes.
8. Intraocular pressure (IOP) \< 21 mmHg in each eye, with and inter-eye difference \< 4 mmHg.
9. Slit-lamp and ophthalmoscopic examinations that are normal or show abnormalities considered not clinically significant by the investigator.

Exclusion Criteria:

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General Exclusion Criteria:

1. Known or suspected hypersensitivity to any component of the investigational product, or a history of multiple allergies two or more allergens).
2. History or presence of any clinically significant diseases or abnormality, including but not limited to cardiovascular, cerebrovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatologic, oncologic, hematologic, immunologic, infectious, neurologic or psychiatric conditions, or any acute or chronic condition that may interfere with study assessments.
3. Participation in any investigational drug or medical device trial within 90 days prior to study drug administration.
4. Use of prescription or over-the-counter medications within 14 days prior to dosing, or unwillingness to discontinue such medications during the study.
5. Receipt of systemic corticosteroid therapy within 6 months prior to dosing.
6. History of alcohol abuse or substance abuse within 2 years prior to dosing.
7. Regular smoking of ≥ 5 cigarettes per day (or equivalent tobacco use) within 12 weeks prior to screening, or inability/unwillingness to abstain during the study.
8. Average alcohol consumption \>14 units per week within 12 weeks prior to screening (1 unit approximately equivalent to 360 mL beer, 150 mL wine, or 45 mL of 40% spirits).
9. History or evidence of intravenous illicit drug use; positive test for HIV, HCV, HBsAg, anti-HCV, anti-HIV, or Treponema pallidum antibody at screening.
10. Blood donation or receipt of blood products within 30 days prior to dosing.
11. History of bleeding disorders or coagulation abnormalities.
12. Clinically significant abnormalities on physical examination, vital signs, 12-lead ECG, or laboratory results at screening.

    Abnormal findings that normalize on repeat testing may be accepted if assessed not clinically significant by the investigator.
13. Current or past use of bariatric medications or history of bariatric surgery (e.g., gastric bypass).
14. Impaired mental status or other factors that may compromise adherence to study requirements.
15. Any conditions that, in the investigator's judgment, may interfere with study assessments or pose the participant to unacceptable risks.

    Ophthalmology Exclusion Criteria:
16. History of ocular surgery, ocular trauma, or chronic eye disease.
17. Current use of contact lenses or use within 2 weeks prior to first dosing.
18. Ocular abnormalities or symptoms considered clinically significant by the investigator.
19. Use of intraocular injectable or implantable therapies, or topical ophthalmic medications, within 2 months prior to dosing, or expected need during the study.
20. History or evidence of ocular e infection, inflammation, blepharitis, or conjunctivitis within 2 months; history of herpes simplex keratitis.
21. Clinically significant findings on ophthalmic evaluations (slit lamp, BCVA, IOP, OCT/OCTA, or fundus examination) that, in the investigator's judgment, may interfere with ocular safety evaluations.

Where this trial is running

Shanghai

• Shanghai General Hospital — Shanghai, China (Recruiting)

Conditions Healthy