A Phase 1 Study of CDX-0159

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04146129
• Other study ID #: CDX0159-01
• Status: Completed
• Phase: Phase 1
• Start date: October 29, 2019
• Est. completion date: June 26, 2020

Study information

• Verified date: July 2020
• Source: Celldex Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 26, 2020
• Est. primary completion date: April 6, 2020
• 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 = 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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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

Locations

Country	Name	City	State
United States	Altasciences Clinical Kansas, Inc.	Overland Park	Kansas

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 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.