A Pharmacokinetics (PK) Study in Healthy Adults

NCT06911216 | Completed Early Phase 1

• 1 other identifier: 101380004CN
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blepharoptosis

Outcome Measures

Primary Outcomes (8)

• PK (Pharmacokinetic) parameter to measure: Cmax

  Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. Cmax - Peak concentration

  Day 1, 5, 6, and 7

• PK parameter to measure: Cmin

  Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. Cmin - Minimum concentration

  Day 1, 5, 6, and 7

• PK parameter to measure: Tmax

  Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. Tmax - Peak time

  Day 1, 5, 6, and 7

• PK parameter to measure: AUC0-24h

  Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. AUC0-24h - The area under the drug-time curve for the quantifiable time period from 0 to 24 hours after drug administration.

  Day 1, 5, 6, and 7

• PK parameter to measure: AUC0-36h

  Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. AUC0-36h - The area under the drug-time curve from 0 to 36 hours after drug administration

  Day 1, 5, 6, and 7

• PK parameter to measure: AUCinf

  Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. AUCinf - The area under the drug-time curve from 0 to infinity after drug administration

  Day 1, 5, 6, and 7

• PK parameter to measure: kel

  Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. kel - Elimination rate constant. The negative of the slope value obtained by taking the logarithm of the plasma concentration in the vanishing phase of the time curve and performing linear regression on time obtained.

  Day 1, 5, 6, and 7

• PK parameter to measure: t½

  Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. t½ - Elimination half-life

  Day 1, 5, 6, and 7

Study Arms (1)

STN1013800 ophthalmic solution

EXPERIMENTAL

0.1% STN1013800 ophthalmic solution administered once daily (QD) for 7 days

Drug: STN1013800 ophthalmic solution

Interventions

STN1013800 ophthalmic solution DRUG

Investigational Product: 0.1% STN1013800 ophthalmic solution once daily (QD) (9AM ± 60 min), one drop for each eye

STN1013800 ophthalmic solution

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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)
• Negative test for selected drugs of abuse, cotinine and alcohol at the Screening visit and on Day -1.
• Negative serum hepatitis panel, negative Human Immunodeficiency Virus (HIV), and treponema pallidum antibody tests at the Screening visit.
• Negative pregnancy test for females of childbearing potential at the Screening visit and on Day -1.
• Understands the study requirements and willing to participate in the study.

You may not qualify if:

• 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.
• Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 28 days before Day-1.
• Current use of a beta blocker or tricyclic antidepressant.
• Any history of ocular hypertension or glaucoma; heart disease, angina, arteriosclerotic disease, or irregular heartbeat; hyperthyroidism; diabetes mellitus; poor peripheral venous access.
• Any history of tuberculosis and/or prophylaxis for tuberculosis.
• Urinary hesitancy or retention from prostatic hypertrophy.
• Receipt or donation of any blood products within 3 months prior to Day-1.
• History or presence of alcoholism or drug abuse or dependence (addiction), as determined at the discretion of the Investigator, within the past 2 years.

Sponsors & Collaborators

• Santen Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 4, 2025
• Study Start: March 17, 2025
• Primary Completion: April 7, 2025
• Study Completion: April 7, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

CN (1)