New eye drop put to the test in healthy volunteers
NCT ID NCT07313722
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai General Hospital
RECRUITINGShanghai, 200080, China
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