A Phase 1 Study of Subcutaneous CDX-0159 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: CDX-0159; Drug: Normal saline

• Registration Number: NCT05031624
• Lead Sponsor: Celldex Therapeutics

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 Timeline

• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-08-25
• Study Start: 2021-08-30
• Study First Posted: 2021-09-02
• Status Verified: 2022-01
• Primary Completion: 2022-01-14
• Study Completion: 2022-01-14
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CDX-0159	CDX-0159	Subjects will receive a single dose of CDX-0159
Normal Saline	Normal saline	Subjects will receive a single dose of normal saline

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
CDX-0159 serum evaluations over time	Day 1 to Day 85	CDX-0159 serum concentrations will be measured at specified visits
Measurement of Anti-drug Antibody development over time	Day 1 to Day 85	Patients will be monitored for the development of anti-drug antibodies.

Trial Locations

Locations (1)

Celerion, Inc; 🇺🇸 Lincoln, Nebraska, United States