A Phase 1 Study of CDX-0159

• Sponsor: Celldex Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04146129
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.9
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: CDX-0159; Drug: Normal saline	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 29, 2019
• Actual Primary Completion Date: Apr 6, 2020
• Actual Study Completion Date: Jun 26, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety as assessed by CTCAE v5.0 [Day 1 to Day 43.]

   Safety of single, ascending doses of CDX-0159 as determined by percentage of participants with adverse events as assessed by CTCAE v5.0.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altasciences Clinical Kansas, Inc.	Overland Park	Kansas	United States	66212

Sponsors and Collaborators

• Celldex Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celldex Therapeutics
• ClinicalTrials.gov Identifier: NCT04146129
• Other Study ID Numbers: CDX0159-01
• First Posted: Oct 31, 2019
• Last Update Posted: Jul 7, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Celldex Therapeutics: CDX-0159

Study Results

No Results Posted as of Jul 7, 2020