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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05031624
Other study ID # CDX0159-05
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 30, 2021
Est. completion date January 14, 2022

Study information

Verified date January 2022
Source Celldex Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a study to determine the safety and pharmacokinetics of CDX-0159 administered subcutaneously in healthy subjects.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date January 14, 2022
Est. primary completion date January 14, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 exclusion criteria could apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CDX-0159
Single subcutaneous dose of one of four dosages of CDX-0159
Normal saline
Single subcutaneous dose of normal saline

Locations

Country Name City State
United States Celerion, Inc Lincoln Nebraska

Sponsors (1)

Lead Sponsor Collaborator
Celldex Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials 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 Day 1 to Day 85
Secondary CDX-0159 serum evaluations over time CDX-0159 serum concentrations will be measured at specified visits Day 1 to Day 85
Secondary Serum tryptase levels over time The effect of CDX-0159 on serum tryptase levels Day 1 to Day 85
Secondary Plasma levels over time The effect of CDX-0159 on stem cell factor levels Day 1 to Day 85
Secondary Measurement of Anti-drug Antibody development over time Patients will be monitored for the development of anti-drug antibodies. Day 1 to Day 85
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