CDX-622 for Healthy Subjects

Overseen By Celldex Therapeutics

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Celldex Therapeutics

Must not be taking: Allergy meds, Asthma inhalers

Disqualifiers: Pregnancy, Asthma, Allergies, others

Compensation: Varies

Number of Visits: Unknown

Duration: 18 weeks

56 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

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

Eligibility Criteria

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

I have signed the informed consent form.

I am a healthy person between 18 and 55 years old.

I am in good health with no major medical issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to three doses of CDX-622 or placebo

18 weeks

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CDX-622

Trial Overview The trial is testing CDX-622's safety in healthy individuals compared to a placebo (normal saline). It aims to understand how well people tolerate this new substance and what effects it may have when no underlying disease is present.

Participant Groups

Group I: CDX-622 Experimental Treatment 1 Intervention

Eligible participants will receive up to four doses of CDX-622.

Group II: Normal Saline Placebo Group 1 Intervention

Eligible participants will receive up to four doses of Normal Saline.

Who Is Running the Clinical Trial?

Celldex Therapeutics

Lead Sponsor

Trials

66

Recruited

5,900+

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