A study to evaluate safety, tolerability and PK of HL217 eye drops
Research type
Research Study
Full title
A dose block-randomized, double blind, placebo controlled, dose-escalation clinical trial to evaluate the safety, tolerability and pharmacokinetics after single dosing of HL217 eye drop in healthy male subjects.
IRAS ID
215420
Contact name
Jae Yoon Kim
Contact email
Sponsor organisation
Hanlim Pharm Co.LTD
Eudract number
2016-000094-21
Duration of Study in the UK
0 years, 1 months, 1 days
Research summary
This is a Phase I, first-in-man single ascending dose study to evaluate the safety and tolerability of HL217, an eye drop treatment, which is being developed for the treatment of age-related macular degeneration.\n\nIt is a double-blind, randomised, parallel group study in healthy male volunteers aged 18 to 50. Sixteen volunteers will be enrolled onto the study, and will receive either the active treatment or the matching placebo treatment. There will be 2 cohorts of 8 volunteers (6 treatment vs 2 placebo) receiving the following doses: two drops of 3 mg/mL of the treatment in one eye once a day (low dose) or twice a day (high dose). The treatment will be administered as two drops in one eye for each administration.\n\nThe initial group will have two sentinel volunteers (1 active, 1 placebo). There will be a minimum of 48 hours and a safety review of data prior to dosing the main group of the cohort.\n\nVolunteers will stay in the clinic for a total of 2 nights and will return the day after their check-out for an end of study visit. \n\nAt the end of each dose level, an interim safety report will be issued by the Investigator. A Safety Review Committee (SRC) meeting will be held between the Investigator and the Sponsor representatives, and the decision on how to proceed (e.g. next higher dose) will be based on safety, tolerability, specialist ophthalmological exams and pharmacokinetic data review from the previous dose level.\n\nThe study duration for each volunteer will be approximately 5 weeks, including screening and the end of study visit for each cohort.\n
REC name
HSC REC B
REC reference
16/NI/0202
Date of REC Opinion
20 Oct 2016
REC opinion
Favourable Opinion