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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.
 
ClinicalTrials.gov Identifier: NCT02563938
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Allakos Inc.

Study Description
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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
Atopy Drug: AK001 Drug: Placebo Phase 1

Detailed Description:
AK001 is a monoclonal antibody which may be useful in the treatment of patients with severe allergic diseases.
Study Design
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Study Type : Interventional  (Clinical Trial)
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 : September 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016
Arms and Interventions
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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 Name: Saline solution


Outcome Measures
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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 [ Time Frame: Within 86 days ]

Secondary Outcome Measures :
  1. Immediate hypersensitivity skin testing [ Time Frame: Within 28 days ]
  2. Peripheral blood counts for eosinophils and basophils [ Time Frame: Within 28 days ]
  3. Serum eosinophilic cationic protein (ECP) and tryptase levels [ Time Frame: Within 28 days ]
  4. 24-hour urine measurement of histamine, N-methylhistamine, and 11-beta-prostaglandin F2 [ Time Frame: Within 28 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563938


Locations
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United States, California
Cypress, California, United States
Sponsors and Collaborators
Allakos Inc.
Investigators
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Principal Investigator: Study Director Allakos Inc.
More Information
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Responsible Party: Allakos Inc.
ClinicalTrials.gov Identifier: NCT02563938    
Other Study ID Numbers: AK001-001
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided