drugset / Trial / NCT03648346
A Dose-escalation Clinical Trial After Multiple Dosing of HL217 Eye Drop in Healthy Male Subjects
RandomizedSequentialTriple-blindBasic science
Summary
The study is a single center, double-blind, randomized, parallel group, multiple ascending dose study in 16 healthy male volunteers. Subjects will receive multiple eye drop doses during 14 days of the treatment (HL217 or placebo according to the randomization). There will be 2 cohorts of 8 subjects (6 HL217 vs 2 placebo) receiving the following doses: * Cohort 1 : two drops of 3 mg/mL of the treatment in one eye twice a day (low dose), * Cohort 2 : two drops of 3 mg/mL of the treatment in one eye 4 times a day (high dose).
Timeline
- Start
- 2018-04-04
- Primary completion
- 2018-07-25
- Completion
- 2019-01-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HL217 | Unknown | 3 mg/ml | Other |
Indications
No indication recorded.