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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05031624
• Other study ID #: CDX0159-05
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Healthy Subjects

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