CDX-622 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called CDX-622 to assess its safety in healthy volunteers. Participants will receive either CDX-622 or a placebo (a harmless substance resembling the treatment) through an IV or injection under the skin. The trial seeks individuals who are generally healthy, aged 18-55, and not currently using any medications or nicotine products. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any medications, whether prescribed or over the counter, for at least 4 weeks before starting the study.
Is there any evidence suggesting that CDX-622 is likely to be safe for humans?
Research has shown that CDX-622 was well-tolerated in earlier studies. Participants did not experience major safety issues. The treatment also positively affected certain health markers, suggesting it may be safe for further testing in humans. However, as this is early research, the treatment's full safety is still under study.12345
Why do researchers think this study treatment might be promising?
CDX-622 is unique because it offers a novel approach by being administered either intravenously (IV) or subcutaneously (SC), which provides flexibility in delivery based on patient needs. Unlike standard treatments that might take longer to exhibit effects, CDX-622 is designed to potentially act more quickly, promising faster relief. Researchers are particularly excited about its innovative mechanism of action, which targets biological pathways differently than traditional therapies, possibly leading to improved outcomes and fewer side effects.
What evidence suggests that CDX-622 might be an effective treatment for safety in healthy subjects?
Research has shown that CDX-622 targets mast cells and a protein called TSLP, both linked to certain diseases. Early data suggest that by focusing on these targets, CDX-622 might help in cases where other treatments are less effective. In this trial, some participants will receive CDX-622, while others will receive a placebo of normal saline. Initial studies with healthy participants found that CDX-622 was well tolerated, with no serious side effects or reactions. This finding encourages further research into its effectiveness for specific conditions.12567
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18-55 with a BMI between 18 and 32. Participants must not smoke, use nicotine products, or take any medication within 4 weeks prior to the study drug administration. They should be in good health as determined by physical exams and tests, agree to use contraception during the study and up to 150 days after, and follow all study rules.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to three doses of CDX-622 or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CDX-622
Find a Clinic Near You
Who Is Running the Clinical Trial?
Celldex Therapeutics
Lead Sponsor
Anthony S. Marucci
Celldex Therapeutics
Chief Executive Officer since 2008
MBA from Columbia University, MHL from Brown University
Diane C. Young
Celldex Therapeutics
Chief Medical Officer since 2019
MD from Harvard Medical School, AB in Biochemical Sciences from Harvard University