Overview
This is a study to determine the safety of CDX-622 in healthy participants.
Description
CDX-622 is a bispecific antibody that binds to stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP).
This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-622 in healthy participants.
Eligibility
Key Inclusion Criteria:
- An informed consent signed and dated by the participant.
- 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 kg/m2 to ≤ 32 kg/m2.
- No course of medication, whether prescribed or over the counter, in the 4 weeks before study drug administration.
- Both males and females of childbearing 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.
- History of asthma requiring the use of inhaled medication within the past 5 years.
- Vaccination within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study).
- Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening.
- Positive urine test for alcohol and drugs of abuse.
Additional protocol defined inclusion and exclusion criteria could apply.