A Phase 1 Study of Subcutaneous CDX-0159 in Healthy Subjects
Study Details
Study Description
Brief Summary
This is a study to determine the safety and pharmacokinetics of CDX-0159 administered subcutaneously in healthy subjects.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: CDX-0159 Subjects will receive a single dose of CDX-0159 |
Drug: CDX-0159
Single subcutaneous dose of one of four dosages of CDX-0159
|
Placebo Comparator: Normal Saline Subjects will receive a single dose of normal saline |
Drug: Normal saline
Single subcutaneous dose of normal saline
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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An informed consent signed and dated by the subject.
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Healthy volunteer aged 18-55.
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In generally good health and without significant medical conditions based on physical exam, ECG, and laboratory test results.
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Body mass index (BMI) ≥ 18.5 kg/m2 to ≤ 35 kg/m2
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No medication other than mild analgesics, vitamins and mineral supplements or, oral contraceptives.
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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.
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Not a current smoker, vaper, or regular user of any nicotine or cannabinoid containing products
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Willing to follow all study rules
Key Exclusion Criteria:
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Women who are pregnant or nursing
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History of anaphylaxis or systemic reactions to food or other triggers
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Autoimmune disorders requiring more than topical medication
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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).
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Positive urine test for alcohol and drugs of abuse.
Other Protocol defined inclusion and exclusion criteria could apply.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Celerion, Inc | Lincoln | Nebraska | United States | 68502 |
Sponsors and Collaborators
- Celldex Therapeutics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDX0159-05