A Pharmacokinetics (PK) Study in Healthy Adults (NCT06911216) | Clinical Trial Compass
CompletedEarly Phase 1
A Pharmacokinetics (PK) Study in Healthy Adults
China8 participantsStarted 2025-03-17
Plain-language summary
This is to characterize STN1013800 active ingredient bioavailability following multiple-dose ocular administration of STN1013800 to both eyes in healthy adults.
It is a PK study with screening period of up to 28 days + dosing period of 7 days + Follow-up period of 2 days.
At present, there are no medicines for the treatment of acquired blepharoptosis in China.
Therefore, efficacy and safety phase III study is also currently being conducted.
Who can participate
Age range
18 Years – 45 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
. Must be able to understand and sign the informed consent form approved by the independent ethics committee.
. Age: 18～45 years old; male and female genders.
. Best corrected visual acuity≥1.0 with no diagnosed ocular or rheumatologic disorders (e.g. dry eyes) that may affect vision.
. Current non-smokers who have not used tobacco or nicotine in any form (including non-nicotine vaping/electronic cigarette products) at least 6 months prior to Day -1.
. Weigh at least 50 kg and have a standard Body Mass Index (BMI) (19-24, Boundary containing value) at the time of screening.
. Female volunteers, for pregnancy avoidance/prevention, the subject should be sterile, postmenopausal or approved methods of contraception.
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.
. Male volunteers for pregnancy avoidance/prevention of subject's female partner (if any), the subject should be sterile, not sexually active, or using approved methods of contraception.
. Judged by the Investigator to be healthy based on the medical history and screening procedures (physical examination, 12-lead ECG, vital signs, and laboratory test results)
Exclusion criteria
. Participation in any other investigational study drug trial in which receipt of an investigational study drug or device occurred within 30 days prior to Day -1.
. Contact lenses wearing during dose administration.
. Use of any over-the-counter (OTC), non-prescription preparations (including multivitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within the 14 days or 5 half-lives, whichever is longer, prior to Day -1.
. Use of any prescription medications within the 14 days or 5 half-lives, whichever is longer prior to Day -1.
. History or presence of any significant metabolic, allergic, cardiovascular, pulmonary, hepatic, renal, hematologic (including bleeding disorders), gastrointestinal (including peptic ulcer disease, gastritis or bleeding diathesis, excluding appendectomy or hernia repair), endocrine, immunologic, dermatologic, muscular, genitourinary, neurological, ophthalmologic, psychiatric, neoplastic, or other disease, that, in the opinion of the investigator, could interfere with the course of the study or expose the subject to undue risk by participating in this study.
. Known hypersensitivity or idiosyncratic reaction to oxymetazoline or any related products (including excipients of the formulation) as well as severe hypersensitivity to any drugs.
. History of cancer within the past 5 years, except for basal cell carcinoma with documentation of a 6-month remission at the Screening visit.
. Any clinically significant illness in the previous 28 days before Day-1.