Trials / Completed
CompletedNCT02717208
Phase 1 Study for Safety and Tolerability of HL036
A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Local Tolerability and Pharmacokinetic Characteristics After Administration of Eye-drop HL036 in Healthy Korean Male Volunteers (Phase I)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- HanAll BioPharma Co., Ltd. · Industry
- Sex
- Male
- Age
- 20 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the safety, local tolerability and pharmacokinetic characteristics after administration of eye-drop HL036 in healthy Korean male volunteers
Detailed description
A total of 10 subjects will be dosed in each group with subjects randomized 8:2 to HL036 or placebo. Three of 10 subjects will be randomized to the sentinel dosing in each group. A safety data review as masking will be performed for 3days prior to the other subjects treatment. Treatment of high dose will proceed following a review of safety data from low dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HL036 | |
| BIOLOGICAL | Vehicle |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2016-03-23
- Last updated
- 2016-12-09
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02717208. Inclusion in this directory is not an endorsement.