Potential Treatment for Mild to Moderate Asthma

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Celldex Therapeutics

Must not be taking: NULL

Disqualifiers: Smoking, Pulmonary disease, Severe asthma, others

Compensation: Varies

Number of Visits: 9 visits

Duration: up to 16 weeks

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests CDX-622, an experimental treatment, to evaluate its safety and behavior in the body for individuals with mild to moderate asthma. The primary goal is to assess its safety and how the body processes the treatment. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

Some medications can be continued and others will need to be stopped. It's best to discuss this with the study doctor to understand how your medications might interact with the trial.

Is there any evidence suggesting that CDX-622 is likely to be safe for humans?

Research has shown that CDX-622 appears safe so far. In an earlier study, participants tolerated CDX-622 well, and the drug functioned smoothly in their bodies with no major side effects. Additionally, CDX-622 did not trigger any unwanted reactions from the body's defense system. These early findings can be encouraging.

Why do researchers think this study treatment might be promising?

Unlike the standard asthma treatments, which often include inhaled corticosteroids and bronchodilators, CDX-622 offers a novel approach. CDX-622 affects different pathways involved in inflammation signaling. Researchers are excited about CDX-622 because it might provide relief with just a single dose, simplifying treatment and improving compliance for patients.

Are You a Good Fit for This Trial?

Adults over 18 with mild to moderate asthma diagnosed at least a year ago can join this study if they've signed the consent form and can follow the study plan.

Inclusion Criteria

Were you diagnosed with asthma over a year ago?

Is your asthma well controlled using your current medication or inhaler?

Exclusion Criteria

In the past 6 months, have you been hospitalized or taken steroid pills (e.g., prednisone) for your asthma?

Have you smoked or vaped (nicotine and cannabis) in the last 12 months?

Have you ever been diagnosed with a lung condition, other than asthma?

Timeline

Screening

Participants are evaluated to confirm eligibility

Up to 4 weeks

Includes 2 clinic visits

Treatment

Participants receive a single dose of CDX-622 via IV infusion

1 week

Includes 1 clinic visit

Safety Follow-up

Participants are monitored and tested for safety

11 weeks

Includes 6 clinic visits

Treatment Details

Interventions

• CDX-622

Trial Overview

This trial is testing CDX-622's safety and effects on the body in those with mild to moderate asthma. It will look into how the drug behaves inside the body and its impact on asthma symptoms.