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Single-centre, randomised, double blind, placebo controlled, single ascending dose study. The study will comprise of 2 parts: Part A (Cohorts 1 and 2); Part B (Cohorts 3 to 8).
Participants who meet all inclusion and none of the exclusion criteria will be enrolled in the study. Safety and tolerability will be evaluated throughout the study. Blood sampling for PK and PD analysis will be also collected during the course of the study.
Up to approximately 48 participants will be enrolled in the study. Participants will be screened from -28 days prior to dose administration.
Participants will be admitted to the unit on Day -1 and will remain confined to the clinic until completion of Day 4 procedures. On Day 1, participants will receive a single dose of AK002 or placebo and complete study procedures. Participants will return to the clinic for follow up at Days 7, 14, 28, 56, 84 and 112 or end of study (EOS) visit.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Nucleus Network Limited
Not yet recruiting
Published on BioPortfolio: 2016-08-10T08:08:21-0400
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