Treatments and doses
SAD
Subjects (n = 48) were randomly 1: 3 assigned to receive placebo (n = 12) or OCS-05 (n = 36). Due to the interlocking design where some subjects received more than one dose level, overall, 14 received placebo and 42 received OCS-05. In the single ascending dose part (SAD), doses administered with 2 h i.v. infusion were 0.05, 0.2, 0.4, 0.8, 1.6, 2.4 and 3.2 mg/kg. In the multiple ascending dose (MAD) part 2.4 and 3.0 mg/kg doses were administered with 2-h i.v. infusion for 5 consecutive days (Table Summary of study design.SD1: Period 1 (0.05 mg/kg)Period 2 (1.6 mg/kg)SD2: Period 1 (0.2 mg/kg)Period 2 (3.2 mg/kg)SD3: Period 1 (0.4 mg/kg)Period 2 (2.4 mg/kg)SD4: Period 1 (0.8 mg/kg)Day -1 to Day -3Dose administered on Day 1 with a washout of at least 14 days between doses in Period 1 and 2MD1: Period 1 (2.4 mg/kg)MD2: Period 1 (3.0 mg/kg)Day -1 to Day 7Doses administered on Days 1—5SD: Study Day.