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A Phase I Study of CDX-622

A Phase I Study of CDX-622

Recruiting
18-55 years
All
Phase 1

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Overview

This is a study to determine the safety of CDX-622 in healthy participants.

Description

CDX-622 is a bispecific antibody that binds to stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP).

This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-622 in healthy participants.

Eligibility

Key Inclusion Criteria:

  • An informed consent signed and dated by the participant.
  • 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 kg/m2 to ≤ 32 kg/m2.
  • No course of medication, whether prescribed or over the counter, in the 4 weeks before study drug administration.
  • Both males and females of childbearing 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.
  • History of asthma requiring the use of inhaled medication within the past 5 years.
  • Vaccination within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study).
  • Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening.
  • Positive urine test for alcohol and drugs of abuse.

Additional protocol defined inclusion and exclusion criteria could apply.

Study details
    Healthy Participants

NCT06650761

Celldex Therapeutics

25 April 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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