An Early Phase 1 interventional study of STN1013800 ophthalmic solution in Blepharoptosis, sponsored by Santen Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-22.
Sponsored by Santen Pharmaceutical Co., Ltd. · Early Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
0.1% STN1013800 ophthalmic solution administered once daily (QD) for 7 days
Drug: STN1013800 ophthalmic solution
Investigational Product: 0.1% STN1013800 ophthalmic solution once daily (QD) (9AM ± 60 min), one drop for each eye
PK (Pharmacokinetic) parameter to measure: Cmax
Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. Cmax - Peak concentration
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Day 1, 5, 6, and 7
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Santen Pharmaceutical Co., Ltd.