NCT02113293

CyclASol® Phase 1 Study

A Phase 1, Two Period, Double-blind, Randomised, Placebo-controlled, Cross- Over Study Investigating the Safety, Local Tolerability and Systemic Exposure of Cyclosporine A and Placebo (Vehicle) Following Single and Multiple Ocular Doses of CyclASol® and Placebo in Healthy Volunteers (CYS-001).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Novaliq GmbH · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is intended to investigate the tolerability and the safety of Cyclosporine A containing CyclASol® eye drops compared to Placebo (vehicle) in a cohort of healthy volunteers. Subjects will be randomly assigned to dosing with CyclASol® eye drops or Placebo (vehicle) in the first part (first period) of the study, and switched to the alternative dosing in the second part (second period) of the study. An ophthalmological assessment of the eyes will be performed, and a questionnaire will be issued in the beginning and after each dosing. Additionally physical examinations, safety laboratory and ECGs will be performed, and blood samples will be analyzed for Cyclosporine A and Placebo (vehicle).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CyclASol®	Cyclosporine A Solution
DRUG	Placebo (vehicle)	Vehicle Solution

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2014-04-14
• Last updated: 2014-05-20

Locations

1 site across 1 country: Germany