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

Sponsor
Allakos, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02563938
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
6
Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: AK001

Up to six single ascending doses of AK001.

Drug: AK001
Given parenterally.
Placebo Comparator: Saline Solution

Saline solution will be administered as a single infusion.

Drug: Placebo
Other Names:
  • Saline solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of safety and tolerability of AK001 measured by number of subjects with adverse events and dose limiting toxicities (DLTs) respectively [Within 86 days]

    Secondary Outcome Measures

    1. Immediate hypersensitivity skin testing [Within 28 days]

    2. Peripheral blood counts for eosinophils and basophils [Within 28 days]

    3. Serum eosinophilic cationic protein (ECP) and tryptase levels [Within 28 days]

    4. 24-hour urine measurement of histamine, N-methylhistamine, and 11-beta-prostaglandin F2 [Within 28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cypress California United States

    Sponsors and Collaborators

    • Allakos, Inc.

    Investigators

    • Principal Investigator: Study Director, Allakos, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allakos, Inc.
    ClinicalTrials.gov Identifier:
    NCT02563938
    Other Study ID Numbers:
    • AK001-001
    First Posted:
    Sep 30, 2015
    Last Update Posted:
    Jun 29, 2016
    Last Verified:
    Jun 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided

    Study Results

    No Results Posted as of Jun 29, 2016