Clinical trial NCT02563938: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK001
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopy
Lead sponsor: Allakos Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of safety and tolerability of AK001 measured by number of subjects with adverse events and dose limiting toxicities (DLTs) respectively
timeFrame: Within 86 days
Secondary outcomes:
measure: Immediate hypersensitivity skin testing
timeFrame: Within 28 days
measure: Peripheral blood counts for eosinophils and basophils
timeFrame: Within 28 days
measure: Serum eosinophilic cationic protein (ECP) and tryptase levels
timeFrame: Within 28 days
measure: 24-hour urine measurement of histamine, N-methylhistamine, and 11-beta-prostaglandin F2
timeFrame: Within 28 days
Other outcomes:
Locations:
city: Cypress
country: United States
state: California
Study officials:
affiliation: Allakos Inc.
name: Study Director
role: PRINCIPAL_INVESTIGATOR
References: