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



Status:Recruiting
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:September 2015
End Date:March 2016
Contact:Medical Director
Email:thaselkorn@allakos.com

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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

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.

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

Inclusion Criteria:

- BMI between 18-30

- Determined to be in good health

- Clinical laboratory values within limits of normal values

- Normal 12-lead ECG

- Stool sample negative for parasites

- Non-smoker

- Consumed an average of no more than 2 drinks per day within 6 months

- Subjects of reproductive age must use a highly effective method of contraception

- Positive skin test in certain cohorts

- Elevated total eosinophil counts in certain cohorts

Exclusion Criteria:

- Clinically significant medical history conditions or laboratory values

- Receipt of investigational drug, biologic or medical device within 30 days prior to
Screening

- New drug therapy within 1 week of study drug administration

- Antihistamine use within 2 weeks prior to Screening

- Consumption of alcohol within 48 hours of study drug administration

- Positive urine drug test or cotinine test at Screening or Day -1

- History, within the last 2 years, of alcohol abuse, illicit drug use, or significant
mental illness

- Demonstration of veins unsuitable for repeated venipuncture or IV infusion

- Recent treatment with alternative therapies which may confound clinical or laboratory
assessments

- Donation or loss of more than 500 mL of blood within 56 days prior to study drug
administration

- History of malignancy within last 5 years

- History of severe allergic or anaphylactic reactions

- Females who are pregnant or breastfeeding
We found this trial at
1
site
Cypress, California
Principal Investigator: Study Director: Clinical Operations, Allakos
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mi
from
Cypress, CA
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