A Phase 1 Study of CDX-0159

Celldex Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Normal saline; Drug: CDX-0159

Study type: Interventional

Funder types: Industry

Identifiers

NCT04146129

CDX0159-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 exclusion criteria could apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

CDX-0159

Experimental group

Description:

Eligible subjects will receive a single dose of CDX-0159

Treatment:

Drug: CDX-0159

Normal saline

Placebo Comparator group

Description:

Subjects assigned to receive placebo will receive a single dose of normal saline

Treatment:

Drug: Normal saline