Recently added Catalysts

CDX-622

Phase 1

Healthy Participants | Small molecule | Other |Celldex Therapeutics, Inc.|Last Updated: Jul 2, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC

Total Trials1

Total Enrollment85

FDA Designations

No designations recorded

Clinical trial landscape

CDX-622 · 2 trials · 2 indications

Phase 1 2

Indication

NCT07330778A Study of CDX-622 in Participants With Mild to Moderate AsthmaMild to Moderate Asthma

RECRUITING12 Analytics

NCT06650761A Phase I Study of CDX-622Healthy Participants

COMPLETED85 Analytics

PHASE1RECRUITING

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

Mild to Moderate Asthma

NCT0733077812

Unlock trial analytics

PHASE1COMPLETED

A Phase I Study of CDX-622

Healthy Participants

NCT0665076185

Unlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety and tolerability profile of CDX-622 in adults with mild to moderate asthma.

Day 1 up to Day 85 (12 weeks)

Occurrence and incidence of Treatment-Emergent Adverse Events (TEAE) and serious adverse events during the study.

Safety as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials. Infusion reactions will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Day 1 up to Day 127

To evaluate the safety profile as determined by the incidence of adverse events in single or multiple ascending doses of CDX-622 or placebo comparator in healthy participants.

Secondary Endpoints

Change from baseline in fractional exhaled nitric oxide (FeNO) through week 12.

Day 1 up to Day 85 (12 weeks)

Change from baseline in absolute eosinophil count (AEC) through week 12.

Day 1 up to Day 85 (12 weeks)

Change from baseline through week 12 in serum biomarkers.

Day 1 up to Day 85 (12 weeks)

Unlock Study Endpoints

Study Design & Arms

AllocationNA

MaskingNONE

ModelSINGLE_GROUP

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
CDX-622	EXPERIMENTAL	Eligible participants will receive a single dose
Normal Saline	PLACEBO_COMPARATOR	Eligible participants will receive doses of Normal Saline by IV or SC

Interventions

Name	Type	Description
CDX-622	DRUG	Administered Intravenously
Normal Saline	DRUG	Up to 4 infusions or 6 SC injections of normal saline

Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A

SexALL

Healthy VolunteersNo

Study Sites4

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 f...

Countries:United States

Unlock Eligibility Criteria