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 range18 Years β 45 Years
SexALL
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Inclusion criteria
β. Must be able to understand and sign the informed consent form approved by the independent ethics committee.
β. Age: 18ο½45 years old; male and female genders.
β. Best corrected visual acuityβ₯1.0 with no diagnosed ocular or rheumatologic disorders (e.g. dry eyes) that may affect vision.
β. 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.
β. Weigh at least 50 kg and have a standard Body Mass Index (BMI) (19-24, Boundary containing value) at the time of screening.
β. Female volunteers, for pregnancy avoidance/prevention, the subject should be sterile, postmenopausal or approved methods of contraception.
β. 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.
β. 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
β. 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.
β. 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.
β. Use of any prescription medications within the 14 days or 5 half-lives, whichever is longer prior to Day -1.
β. 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.
β. Known hypersensitivity or idiosyncratic reaction to oxymetazoline or any related products (including excipients of the formulation) as well as severe hypersensitivity to any drugs.
β. History of cancer within the past 5 years, except for basal cell carcinoma with documentation of a 6-month remission at the Screening visit.
β. Any clinically significant illness in the previous 28 days before Day-1.