Healthy Subjects
Conditions
Keywords
CDX0159-05
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.
Interventions
DRUGCDX-0159
Single subcutaneous dose of one of four dosages of CDX-0159
DRUGNormal saline
Single subcutaneous dose of normal saline
Sponsors
Celldex Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 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
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 | Day 1 to Day 85 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CDX-0159 serum evaluations over time | Day 1 to Day 85 | CDX-0159 serum concentrations will be measured at specified visits |
| Serum tryptase levels over time | Day 1 to Day 85 | The effect of CDX-0159 on serum tryptase levels |
| Plasma levels over time | Day 1 to Day 85 | The effect of CDX-0159 on stem cell factor levels |
| Measurement of Anti-drug Antibody development over time | Day 1 to Day 85 | Patients will be monitored for the development of anti-drug antibodies. |
Countries
United States
Outcome results
None listed