A Phase 1 Study of CDX-0159

Study Overview
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Brief Summary
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This is a study to determine the safety of CDX-0159 in healthy subjects.

Detailed Description
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CDX-0159 is a humanized monoclonal antibody that binds to a protein called KIT that is expressed on mast cells. This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159 in healthy subjects.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 in Healthy Subjects

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: CDX-0159
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: An informed consent signed and dated by the subject. Healthy volunteer aged 18-55. In generally good health and without significant medical conditions based on physical exam, ECG, and laboratory test results. Body mass index (BMI) ≥ 18.5 kg/m2 to ≤ 30 kg/m2 No medication other than mild analgesics, vitamins and mineral supplements or, oral contraceptives Both males and females of child bearing potential must agree to use a medically accepted contraceptive regimen during study and up to 150 days afterwards. Not a current smoker (or regular user of any nicotine containing product). Willing to follow all study rules Key Exclusion Criteria: Women who are pregnant or nursing History of anaphylaxis, food allergies, or allergies (chronic or seasonal) requiring prescription medication Autoimmune disorders requiring more than topical medication History of asthma requiring the use of inhaled medication within the past 5 years. Vaccination with live vaccines within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study). Positive urine test for alcohol and drugs of abuse. Other Protocol defined inclusion and exclusion criteria could apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDX-0159<br>Eligible subjects will receive a single dose of CDX-0159 | Drug: CDX-0159<br>* Single dose of one of four dosages of CDX-0159<br>|
| Placebo Comparator: Normal saline<br>Subjects assigned to receive placebo will receive a single dose of normal saline | Drug: Normal saline<br>* Single infusion of normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as assessed by CTCAE v5.0 | Safety of single, ascending doses of CDX-0159 as determined by percentage of participants with adverse events as assessed by CTCAE v5.0. | Day 1 to Day 43. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CDX-0159