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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: CDX-0159; Drug: Normal saline

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
CDX-0159 serum evaluations over time	CDX-0159 serum concentrations will be measured at specified visits	Day 1 to Day 85
Serum tryptase levels over time	The effect of CDX-0159 on serum tryptase levels	Day 1 to Day 85
Plasma levels over time	The effect of CDX-0159 on stem cell factor levels	Day 1 to Day 85
Measurement of Anti-drug Antibody development over time	Patients will be monitored for the development of anti-drug antibodies.	Day 1 to Day 85

Collaborators and Investigators

• Sponsor: Celldex Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): January 14, 2022
• Study Completion (Actual): January 14, 2022

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: CDX0159-05
• Other Study ID Numbers: CDX0159-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No