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

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

Official Title
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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

Conditions
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Atopy

Intervention / Treatment
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* Drug: AK001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AK001<br>Up to six single ascending doses of AK001. | Drug: AK001<br>* Given parenterally.<br>|
| Placebo Comparator: Saline Solution<br>Saline solution will be administered as a single infusion. | Drug: Placebo<br> <br> * Other names: Saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate hypersensitivity skin testing |  | Within 28 days | 
| 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 |