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

Sponsor
Celldex Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT05031624
Collaborator
(none)
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 30, 2021
Actual Primary Completion Date :
Jan 14, 2022
Actual Study Completion Date :
Jan 14, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Safety as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials [Day 1 to Day 85]

    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

Secondary Outcome Measures

  1. CDX-0159 serum evaluations over time [Day 1 to Day 85]

    CDX-0159 serum concentrations will be measured at specified visits

  2. Serum tryptase levels over time [Day 1 to Day 85]

    The effect of CDX-0159 on serum tryptase levels

  3. Plasma levels over time [Day 1 to Day 85]

    The effect of CDX-0159 on stem cell factor levels

  4. Measurement of Anti-drug Antibody development over time [Day 1 to Day 85]

    Patients will be monitored for the development of anti-drug antibodies.

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 ≤ 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Celerion, Inc Lincoln Nebraska United States 68502

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:
NCT05031624
Other Study ID Numbers:
  • CDX0159-05
First Posted:
Sep 2, 2021
Last Update Posted:
Jan 21, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Celldex Therapeutics

Study Results

No Results Posted as of Jan 21, 2022