Clinical Evaluation of Safety and Tolerability of KDR2-2 Eye Drops in Healthy Volunteers With Pharmacokinetic Assessment
Status:
Recruiting
Trial end date:
2021-06-30
Target enrollment:
Participant gender:
Summary
A Phase 1 randomized, double blinded, placebo-controlled, single dose escalation (SDE) and
repeat dose escalation (RDE) study to evaluate safety and tolerability, and PK of KDR2-2 in
healthy volunteers. The planned single dose levels are 0.03, 0.06, 0.12, and 0.24 mg/eye, and
repeat dose levels are 0.06, 0.12, and 0.24 mg/eye, QID, × 6 days (one dose in the morning on
Day 7). Subjects are randomized to KDR2-2 or placebo dosing (6:2 for SDE, or 8:2 for RDE) in
each cohorts of relative dosing levels.