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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK002 | Experimental | AK002 will be administered as an intravenous (IV) infusion in 8 cohorts of single escalating doses and two cohorts with multiple doses |
|
| Placebo | Placebo Comparator | Placebo administered as anl IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK002 | Drug | IV AK002 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of AK002 as assessed by incidence, nature and severity of AEs and SAEs. | Screening to day 112 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate pharmacokinetic parameter AUC for AK002. | Baseline to Day 112 | |
| Change from baseline of absolute peripheral blood counts of eosinophils. | baseline to Day 112 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Lickliter, MBBS PhD | Nucleus Network Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Limited | Melbourne | Australia |
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| ID | Term |
|---|---|
| C000654568 | AK002 |
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| Other |
|
| Change from baseline of absolute peripheral blood counts of basophils. |
| baseline to Day 112 |
| Changes in serum tryptase levels | baseline to Day 112 |
| Evaluate pharmacokinetic parameter CMAX for AK002. | baseline to day 112 |
| Changes in Eosinophilic Cationic protein levels | Baseline to day 112 |