NCT06911216

A Pharmacokinetics (PK) Study in Healthy Adults

A Multiple-Dose Pharmacokinetics (PK) Study of STN1013800 in Healthy Adults

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Santen Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

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

Timeline

• Start date: 2025-03-17
• Primary completion: 2025-04-07
• Completion: 2025-04-07
• First posted: 2025-04-04
• Last updated: 2025-04-22

Locations

1 site across 1 country: China