A Phase 1 Study of CDX-0159

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 in Healthy Subjects

This is a study to determine the safety of CDX-0159 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.

This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159 in healthy subjects.

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

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Altasciences Clinical Kansas, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• 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 ≤ 30 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 (or regular user of any nicotine containing product).
• Willing to follow all study rules

Key Exclusion Criteria:

• Women who are pregnant or nursing
• History of anaphylaxis, food allergies, or allergies (chronic or seasonal) requiring prescription medication
• Autoimmune disorders requiring more than topical medication
• History of asthma requiring the use of inhaled medication within the past 5 years.
• Vaccination with live vaccines within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study).
• 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: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CDX-0159; Eligible subjects will receive a single dose of CDX-0159	Drug: CDX-0159; Single dose of one of four dosages of CDX-0159
Placebo Comparator: Normal saline; Subjects assigned to receive placebo will receive a single dose of normal saline	Drug: Normal saline; Single infusion of normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as assessed by CTCAE v5.0	Safety of single, ascending doses of CDX-0159 as determined by percentage of participants with adverse events as assessed by CTCAE v5.0.	Day 1 to Day 43.

Collaborators and Investigators

• Sponsor: Celldex Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2019
• Primary Completion (Actual): April 6, 2020
• Study Completion (Actual): June 26, 2020

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: CDX-0159
• Other Study ID Numbers: CDX0159-01

Drug and device information, study documents

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