Safety evaluation of CDX-622 in healthy volunteers
A Randomized, Double-Blind, Placebo-Controlled, Two-Part, Phase 1a Dose Escalation Clinical Trial to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-622 in Healthy Participants
This study is testing a new antibody called CDX-622 in healthy volunteers to see if it’s safe and how it works in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Celldex Therapeutics Industry-sponsored |
| Locations | 1 site (Tempe, Arizona) |
| Trial ID | NCT06650761 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, pharmacokinetics, and pharmacodynamics of CDX-622, a bispecific antibody targeting stem cell factor and thymic stromal lymphopoietin, in healthy participants. The trial involves administering CDX-622 and monitoring participants for any adverse effects. Healthy volunteers aged 18-55 will be recruited, and their health will be assessed through physical exams, ECGs, and laboratory tests. The study aims to gather important safety data that could inform future research and therapeutic applications.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-55 who meet specific health criteria and are willing to comply with study protocols.
Not a fit: Patients with significant medical conditions, allergies, or those who are pregnant or nursing will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical safety data for the use of CDX-622 in future treatments.
How similar studies have performed: While this approach is focused on safety evaluation, similar studies of bispecific antibodies have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tempe, Arizona
- Celerion, Inc. — Tempe, Arizona, United States (Recruiting)
Study contacts
- Study coordinator: Celldex Therapeutics
- Email: clinicaltrials@celldex.com
- Phone: 844-723-9363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.