Conditions: Schizophrenia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 54
Healthy volunteers: yes

Brief summary:
This is a prospective, 8-day, randomized, double-blind, placebo-controlled, sequential-cohort study designed to evaluate the safety, tolerability, and MTD of single escalating oral doses of NW-3509A in healthy male volunteers. Six independent cohorts of 12 volunteers each will participate in this study, with the first 9 volunteers in each cohort to qualify being randomized to receive study medication and the remaining 3 to be used as backups/ alternates. In each cohort, 6 subjects will be randomly assigned to receive NW-3509A and 3 subjects will receive placebo.

Detailed description:
Doses from 1 to 30 mg were tested

Arms:
arm 1: NW-3509a - 1mg or placebo arm 2: NW-3509a 2mg or placebo arm 3: NW-3509a 5mg or placebo arm 4: NW-3509a 10 mg or placebo arm 5: NW-3509a 20 mg or placebo arm 6: NW-3509a 30 mg or placebo

Interventions: intervention 1: NW-3509a
Intervention descriptions: intervention 1: single dose

Protocol document: