NCT02563938

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK001

A Phase 1, Randomized, Double-Blind, Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK001 in Subjects With Atopic Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Allakos Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This first-in-human study will evaluate the safety and tolerability of single doses of AK001 across a range of potentially active doses. Early signals of pharmacodynamic activity will also be evaluated.

Detailed description

AK001 is a monoclonal antibody which may be useful in the treatment of patients with severe allergic diseases.

Conditions

• Atopy

Interventions

Type	Name	Description
DRUG	AK001	Given parenterally.
DRUG	Placebo

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-09-30
• Last updated: 2016-06-29

Locations

1 site across 1 country: United States