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

Atopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563938
• Other study ID #: AK001-001
• Status: Completed
• Phase: Phase 1
• First received: September 15, 2015
• Last updated: June 27, 2016
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: Allakos, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopy

Intervention

Drug:
• AK001
Given parenterally.
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allakos, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of safety and tolerability of AK001 measured by number of subjects with adverse events and dose limiting toxicities (DLTs) respectively		Within 86 days	No
Secondary	Immediate hypersensitivity skin testing		Within 28 days	No
Secondary	Peripheral blood counts for eosinophils and basophils		Within 28 days	No
Secondary	Serum eosinophilic cationic protein (ECP) and tryptase levels		Within 28 days	No
Secondary	24-hour urine measurement of histamine, N-methylhistamine, and 11-beta-prostaglandin F2		Within 28 days	No