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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02563938
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : June 29, 2016
Information provided by (Responsible Party):
Allakos Inc.

Tracking Information
First Submitted Date  ICMJE September 15, 2015
First Posted Date  ICMJE September 30, 2015
Last Update Posted Date June 29, 2016
Study Start Date  ICMJE September 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
Evaluation of safety and tolerability of AK001 measured by number of subjects with adverse events and dose limiting toxicities (DLTs) respectively [ Time Frame: Within 86 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
  • Immediate hypersensitivity skin testing [ Time Frame: Within 28 days ]
  • Peripheral blood counts for eosinophils and basophils [ Time Frame: Within 28 days ]
  • Serum eosinophilic cationic protein (ECP) and tryptase levels [ Time Frame: Within 28 days ]
  • 24-hour urine measurement of histamine, N-methylhistamine, and 11-beta-prostaglandin F2 [ Time Frame: Within 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK001
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atopy
Intervention  ICMJE
  • Drug: AK001
    Given parenterally.
  • Drug: Placebo
    Other Name: Saline solution
Study Arms  ICMJE
  • Experimental: AK001
    Up to six single ascending doses of AK001.
    Intervention: Drug: AK001
  • Placebo Comparator: Saline Solution
    Saline solution will be administered as a single infusion.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2015)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02563938
Other Study ID Numbers  ICMJE AK001-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Allakos Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Allakos Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Study Director Allakos Inc.
PRS Account Allakos Inc.
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP