A Phase 1 Study of Subcutaneous CDX-0159 in Healthy Subjects

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

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

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

Conditions
-----------------
Healthy Subjects

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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 ≤ 35 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, vaper, or regular user of any nicotine or cannabinoid containing products Willing to follow all study rules Key Exclusion Criteria: Women who are pregnant or nursing History of anaphylaxis or systemic reactions to food or other triggers Autoimmune disorders requiring more than topical medication Vaccination with live vaccines within 4 months prior to screening visit (subjects must agree to avoid live vaccination during the study and 4 months after). Positive urine test for alcohol and drugs of abuse. Other Protocol defined inclusion and exclusion criteria could apply.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials | Safety of single, ascending doses of CDX-0159 as determined by percentage of participants with adverse events as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials | Day 1 to Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CDX-0159 serum evaluations over time | CDX-0159 serum concentrations will be measured at specified visits | Day 1 to Day 85 | 
| Serum tryptase levels over time | The effect of CDX-0159 on serum tryptase levels | Day 1 to Day 85 | 
| Plasma levels over time | The effect of CDX-0159 on stem cell factor levels | Day 1 to Day 85 | 
| Measurement of Anti-drug Antibody development over time | Patients will be monitored for the development of anti-drug antibodies. | Day 1 to Day 85 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CDX0159-05