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 |
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.
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.
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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