MedTrace Logo

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

NCT02859701 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2017-09-26

No results posted yet for this study

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).

Conditions

  • Healthy

Interventions

DRUG

AK002

IV AK002

OTHER

Placebo

Sponsors & Collaborators

  • Allakos Inc.

    lead INDUSTRY

Principal Investigators

  • Jason Lickliter, MBBS PhD · Nucleus Network Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-05-17
Completion
2017-05-17

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02859701 on ClinicalTrials.gov