Healthy Participants
Conditions
Brief summary
This is a study to determine the safety of CDX-622 in healthy participants.
Detailed 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 IV single ascending doses (Part 1), IV multiple ascending doses (Part 2), and subcutaneous (SC) single ascending doses (Part 3) of CDX-622 in healthy participants.
Interventions
DRUGCDX-622
Up to 4 infusions of one of seven dosages of CDX-622 or up to 1 dose by subcutaneous injection of one of three dosages of CDX-622
DRUGNormal Saline
Up to 4 infusions or 6 SC injections of normal saline
Sponsors
Celldex Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials. Infusion reactions will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | Day 1 up to Day 127 | To evaluate the safety profile as determined by the incidence of adverse events in single or multiple ascending doses of CDX-622 or placebo comparator in healthy participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CDX-622 serum evaluations over time | Day 1 up to Day 127 | CDX-622 serum concentrations will be measured at specified visits |
| CDX-622 biomarker evaluations over time | Day 1 up to Day 127 | The effect of CDX-622 on serum tryptase levels and other relevant biomarkers |
| Measurement of anti-drug antibody development over time | Day 1 up to Day 127 | Participants will be monitored for the development of anti-drug antibodies |
Countries
United States
Outcome results
None listed