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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2016

Detailed Description

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

Interventions

  • Drug: AK001
    • Given parenterally.
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: AK001
    • Up to six single ascending doses of AK001.
  • Placebo Comparator: Saline Solution
    • Saline solution will be administered as a single infusion.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Allakos Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Principal Investigator, Allakos Inc.

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