A Phase 1 Study of CDX-0159
- Registration Number
- NCT04146129
- Lead Sponsor
- Celldex Therapeutics
- Brief Summary
This is a study to determine the safety of CDX-0159 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.
This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159 in healthy subjects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal saline Normal saline Subjects assigned to receive placebo will receive a single dose of normal saline CDX-0159 CDX-0159 Eligible subjects will receive a single dose of CDX-0159
- Primary Outcome Measures
Name Time Method Safety as assessed by CTCAE v5.0 Day 1 to Day 43. Safety of single, ascending doses of CDX-0159 as determined by percentage of participants with adverse events as assessed by CTCAE v5.0.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Altasciences Clinical Kansas, Inc.
🇺🇸Overland Park, Kansas, United States