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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04146129

Enrollment

Registered

2019-10-31

Start date

2019-10-29

Completion date

2020-06-26

Last updated

2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

CDX-0159

Brief summary

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

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.

Interventions

DRUGCDX-0159

Single dose of one of four dosages of CDX-0159

DRUGNormal saline

Single infusion of normal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026