NCT02859701

Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AK002 in Healthy Participants

A Phase 1, Double-Blind, Placebo-Controlled, Single Ascending and Multi Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AK002 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Allakos Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	AK002	IV AK002
OTHER	Placebo

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-05-17
• Completion: 2017-05-17
• First posted: 2016-08-09
• Last updated: 2017-09-26

Locations

1 site across 1 country: Australia