A Phase I Study of CDX-622

Launched by CELLDEX THERAPEUTICS · Oct 18, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "A Phase I Study of CDX-622," is looking into the safety of a new treatment called CDX-622 in healthy volunteers. The researchers want to ensure that this treatment is safe before it can be tested in people with medical conditions. The study is currently recruiting participants aged 18 to 55 who are in good health, meaning they do not have significant medical issues and meet certain health criteria. Participants must also agree to follow specific guidelines, such as not taking any medications four weeks before the study starts and using contraception if they are capable of becoming pregnant.

If you or someone you know is considering participating, you can expect to undergo some health screenings, including physical exams and lab tests, to confirm eligibility. Participants will need to commit to following the study's rules and attend follow-up appointments. It's important to know that women who are pregnant or nursing, as well as individuals with certain health conditions or recent vaccinations, will not be eligible for this trial. This study is a valuable step in understanding the safety of CDX-622, and your participation could contribute to important medical research.

Gender

ALL

Eligibility criteria

• 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.