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最高研发阶段临床申请批准 |
首次获批国家/地区- |
首次获批日期- |
A Phase 1 Randomized, Double Blinded, Placebo-Controlled Single Dose and Repeat Dose Escalation Study to Evaluate Safety and Tolerability and Pharmacokinetic Characteristics of KDR2-2 in Adult Healthy Male and Female Volunteers
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.
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