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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Celldex Therapeutics
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Safety as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •An informed consent signed and dated by the subject.
- •Healthy volunteer aged 18-
- •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
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.
Arms & Interventions
CDX-0159
Subjects will receive a single dose of CDX-0159
Intervention: CDX-0159 (Drug)
Normal Saline
Subjects will receive a single dose of normal saline
Intervention: Normal saline (Drug)
Outcomes
Primary Outcomes
Safety as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials
Time Frame: 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 Outcomes
- Serum tryptase levels over time(Day 1 to Day 85)
- Plasma levels over time(Day 1 to Day 85)
- CDX-0159 serum evaluations over time(Day 1 to Day 85)
- Measurement of Anti-drug Antibody development over time(Day 1 to Day 85)