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

Completed · Phase 1 · Has a placebo group

Conditions studied: Atopy

In brief

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.

Key facts

Study ID

NCT02563938

Run by

Allakos Inc.

People needed

34

Starts

2015-09-01

Expected to finish

2016-03-01

Last updated by the study team

2016-06-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Cypress, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.