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Recruiting Phase 1 NCT07330778

A Study of CDX-622 in Participants With Mild to Moderate Asthma

Trial Parameters

Condition Mild to Moderate Asthma
Sponsor Celldex Therapeutics
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 12
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-02
Completion 2027-03
Interventions
CDX-622

Brief Summary

This is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma.

Eligibility Criteria

Key Inclusion Criteria: 1. Males and females, ≥ 18 years of age 2. Diagnosis of mild to moderate asthma for at least 12 months 3. Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted normal 4. Airway reversibility ≥ 12% and 200 mL improvement in FEV1 5. Both males and females of child-bearing potential must agree to use contraception during the study and for 150 days after treatment 6. Willing and able to comply with all study requirements and procedures Key Exclusion Criteria: 1. Females who are pregnant or nursing 2. Pulmonary disease other than asthma 3. Systemic diseases with elevated eosinophils other than asthma 4. Hospitalization or oral corticosteroids due to asthma within the past 6 months 5. History of needing ventilator support due to asthma 6. Current nasal polyps 7. Severe or uncontrolled asthma 8. History of smoking or vaping within the past 12 months 9. Tuberculosis, hepatitis B or C virus, or HIV 10. Immunomodulating biologic therapies withi

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