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A Pharmacokinetics (PK) Study in Healthy Adults

NCT06911216 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-04-22

No results posted yet for this study

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

Interventions

DRUG

STN1013800 ophthalmic solution

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

Sponsors & Collaborators

  • Santen Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2025-04-07
Completion
2025-04-07

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06911216 on ClinicalTrials.gov