A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of RC017 Ophthalmic Oin… (NCT07521748) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of RC017 Ophthalmic Ointment Following Single and Multiple Doses in Healthy Adult Participants
24 participantsStarted 2026-04
Plain-language summary
This is a Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of RC017 Ophthalmic Ointment Following Single and Multiple Doses in Healthy Adult Participants.RC017 is a small-molecule drug, being developed as a novel therapeutic treatment for patients with Dry Eye Disease (DED) . This study aims to evaluate the safety, tolerability and pharmacokinetics of RC017 after Single and Multiple Doses.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy male and female trial participants aged 18 to 55 years old (inclusive);
. Body Mass Index (BMI) ranging from 19.0 to 26.0 kg/m² (inclusive), with body weight ≥ 50 kg for males and ≥ 45 kg for females;
. At screening, best corrected visual acuity (BCVA) of both eyes should be ≥ 1.0; in addition, ophthalmic examinations (including assessment of ocular symptoms, slit-lamp microscopy/external eye examination, corneal fluorescein staining, funduscopy, and intraocular pressure measurement) should show no abnormalities in both eyes, or any abnormalities detected should be judged as clinically insignificant by the investigator;
. Have a full understanding of the trial procedures, voluntarily participate in the trial, and sign a written informed consent form (ICF);
. Female participants with childbearing potential must have a negative result in the serum pregnancy test at screening. Throughout the entire study period and within 3 months after the study conclusion, all female participants, male participants and their sexual partners must agree to adopt effective contraceptive measures (Note: Contraceptive measures include both pharmacological and non-pharmacological methods, see Appendix 4 for details).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of Treatment-emergent adverse events (TEAEs)
Timeframe: Day1 to Day 21
2
The severity of Treatment-emergent adverse events (TEAEs)
Timeframe: Day 1-Day 21
3
The incidence of Serious adverse events (SAEs)
Timeframe: Day 1-Day 21
4
The severity of Serious adverse events (SAEs)
Timeframe: Day 1-Day 21
5
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Timeframe: Day 1-Day 21
6
Number of participants with abnormal clinically significant clinical laboratory results
Timeframe: Day 1- Day 21
7
Number of patients with abnormal clinically significant results from physical examination
. History of ocular diseases deemed by the investigator as unsuitable for enrollment, including but not limited to dry eye, glaucoma, blepharitis, meibomianitis, allergic conjunctivitis, iritis, uveitis, and/or active ocular inflammation or infection.
. Prior history of ocular surgeries, including laser refractive surgery and intraocular surgery, etc.
. Participants who wore contact lenses or cosmetic colored contact lenses within 2 weeks prior to screening, or those requiring contact lens wear during the trial.
. Use of any prescription or over-the-counter (OTC) medications (including vitamins, antacids, Chinese herbal medicines, dietary supplements, and topical ophthalmic drugs) within 2 weeks prior to screening.
. Clinically significant abnormalities in vital signs, physical examination findings, laboratory test results (complete blood count \[CBC\], urine routine, blood biochemistry, coagulation function, infectious disease screening, serum pregnancy test \[females only\]) or 12-lead electrocardiogram (ECG), as judged by the investigator.
. History of diseases involving the central nervous, mental, cardiovascular, renal, hepatic, respiratory, metabolic, or musculoskeletal systems, which in the investigator's judgment may compromise participant safety or interfere with study results.
. Clinically significant history of allergies, especially drug allergies, or known hypersensitivity to any component of the study drug.
. Daily cigarette smoking \> 5 sticks within 3 months prior to the trial.