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New eye drop put to the test in healthy volunteers

NCT ID NCT07313722

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study is testing a new eye drop called BT01001 in 32 healthy adults to see if it is safe and how the body processes it. Participants will receive either the eye drop or a placebo (inactive drop) and be monitored for side effects. Since this is a Phase 1 trial in healthy volunteers, there is no direct treatment benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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: \- 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Shanghai General Hospital

    RECRUITING

    Shanghai, 200080, China

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