RecruitingPhase 1NCT07330778
A Study of CDX-622 in Participants With Mild to Moderate Asthma
An Open-Label, Single-Dose Study to Assess the Safety, Pharmacodynamics, and Pharmacokinetics of CDX-622 in Adults With Mild to Moderate Asthma
Sponsor
Celldex Therapeutics
Enrollment
12 participants
Start Date
Feb 1, 2026
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria6
- Males and females, ≥ 18 years of age
- Diagnosis of mild to moderate asthma for at least 12 months
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted normal
- Airway reversibility ≥ 12% and 200 mL improvement in FEV1
- Both males and females of child-bearing potential must agree to use contraception during the study and for 150 days after treatment
- Willing and able to comply with all study requirements and procedures
Exclusion Criteria11
- Females who are pregnant or nursing
- Pulmonary disease other than asthma
- Systemic diseases with elevated eosinophils other than asthma
- Hospitalization or oral corticosteroids due to asthma within the past 6 months
- History of needing ventilator support due to asthma
- Current nasal polyps
- Severe or uncontrolled asthma
- History of smoking or vaping within the past 12 months
- Tuberculosis, hepatitis B or C virus, or HIV
- Immunomodulating biologic therapies within the past 3 months
- Prior receipt of TSLP or KIT inhibitors such as tezepelumab or briquilimab
Interventions
DRUGCDX-622
Administered Intravenously
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07330778