Finding studies
Finding studies
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Lead
Edge Therapeutics Inc
This is a Phase 1/2a multicenter, controlled, open label, and randomized, study. Part 1 of the study is a single dose escalation period to determine the MTD of EG-1962. During this period, a maximum of 6 dose level cohorts with up to 12 patients per cohort will be enrolled. In each cohort, patients will be randomly assigned in a ratio of 3:1 to receive either intraventricular EG 1962 or enteral nimodipine, respectively. The first cohort will receive 100 mg EG 1962. Upon completion of the dose escalation period, a safe and tolerable dose will be selected for further study. Part 2 of the study is a treatment period to assess the safety and tolerability of the selected dose of EG-1962. The safety and tolerability of a single intraventricular dose of EG 1962 will be compared to enteral nimodipine (60 mg given every 4 hours orally or via nasogastric or gastrostomy tube) for 21 days.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
