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

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

Tracking Information

• First Submitted Date: September 15, 2015
• First Posted Date: September 30, 2015
• Last Update Posted Date: June 29, 2016
• Study Start Date: September 2015
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Atopy

Intervention

• Drug: AK001
  Given parenterally.
• Drug: Placebo
  Other Name: Saline solution

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 28, 2015): 34
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2016
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02563938
• Other Study ID Numbers: AK001-001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Allakos Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Allakos Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Study Director; Allakos Inc.

• PRS Account: Allakos Inc.
• Verification Date: June 2016