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.
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);
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.
Parallel
RC017 Ophthalmic Ointment
DrugParticipants were randomly assigned to the 3 dose groups
RC017 Ophthalmic Ointment placebo
DrugMatch to RC017 Ophthalmic Ointment dose groups
The incidence of Treatment-emergent adverse events (TEAEs)
The severity of Treatment-emergent adverse events (TEAEs)
The incidence of Serious adverse events (SAEs)
The severity of Serious adverse events (SAEs)
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
AUC from time zero to infinity (AUC0-∞)
Maximum observed concentration (Cmax)
Time of maximum observed concentration (Tmax)
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