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

Phase 1

Completed

• Conditions: Atopy
• Interventions: Drug: AK001; Drug: Placebo

• Registration Number: NCT02563938
• Lead Sponsor: Allakos Inc.

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 Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-15
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-30
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-27
• Last Update Posted: 2016-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK001	AK001	Up to six single ascending doses of AK001.
Saline Solution	Placebo	Saline solution will be administered as a single infusion.

Primary Outcome Measures

Name	Time	Method
Evaluation of safety and tolerability of AK001 measured by number of subjects with adverse events and dose limiting toxicities (DLTs) respectively	Within 86 days

Secondary Outcome Measures

Name	Time	Method
Peripheral blood counts for eosinophils and basophils	Within 28 days
Serum eosinophilic cationic protein (ECP) and tryptase levels	Within 28 days
24-hour urine measurement of histamine, N-methylhistamine, and 11-beta-prostaglandin F2	Within 28 days
Immediate hypersensitivity skin testing	Within 28 days