Single-centre, randomised, double blind, placebo controlled, single ascending dose study and multiple dose study. AK002 will be administered as an intra-venous (IV) infusion in eight cohorts of single escalating doses and two cohorts with multiple doses. The study will comprise of 3 parts: Part A (Cohorts 1 - single ascending dose); Part B (Cohorts 2 to 9 - single ascending dose); Part C (Cohorts 10 and 11 - multiple dose).
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. In parts A and B, 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. In part C, In Part C, participants will be admitted to the unit on Day -1 and will remain confined to the clinic until completion of Day 2 procedures. On Day 1, participants will receive a dose of AK002 or placebo and complete procedures as detailed in Table 2. Participants will return to the clinic for follow up at Days 4, 7 and 14, and on Day 28 participants will receive a second dose of study drug (AK002 or a corresponding placebo) and will remain confined to the clinic until completion of the Day 29 procedures. Participants will return to the clinic for follow up at Days 31, 35, 42, 56, 84 and 112 or end of study (EOS) visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
51
Nucleus Network Limited
Melbourne, Australia
Safety and tolerability of AK002 as assessed by incidence, nature and severity of AEs and SAEs.
Time frame: Screening to day 112
Evaluate pharmacokinetic parameter AUC for AK002.
Time frame: Baseline to Day 112
Change from baseline of absolute peripheral blood counts of eosinophils.
Time frame: baseline to Day 112
Change from baseline of absolute peripheral blood counts of basophils.
Time frame: baseline to Day 112
Changes in serum tryptase levels
Time frame: baseline to Day 112
Evaluate pharmacokinetic parameter CMAX for AK002.
Time frame: baseline to day 112
Changes in Eosinophilic Cationic protein levels
Time frame: Baseline to day 112
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