A Phase I Study of CDX-622

Phase 1

Recruiting

• Conditions: Healthy Participants
• Interventions: Drug: CDX-622; Drug: Normal Saline

• Registration Number: NCT06650761
• Lead Sponsor: Celldex Therapeutics

Brief Summary

This is a study to determine the safety of CDX-622 in healthy participants.

Detailed Description

CDX-622 is a bispecific antibody that binds to stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP).

This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-622 in healthy participants.

Study Timeline

• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-18
• Study First Posted: 2024-10-21
• Study Start: 2024-11-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDX-622	CDX-622	Eligible participants will receive up to four doses of CDX-622.
Normal Saline	Normal Saline	Eligible participants will receive up to four doses of Normal Saline.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
CDX-622 serum evaluations over time	Day 1 up to Day 127	CDX-622 serum concentrations will be measured at specified visits
CDX-622 biomarker evaluations over time	Day 1 up to Day 127	The effect of CDX-622 on serum tryptase levels and other relevant biomarkers
Measurement of anti-drug antibody development over time	Day 1 up to Day 127	Participants will be monitored for the development of anti-drug antibodies

Trial Locations

Locations (1)

Celerion, Inc.; 🇺🇸 Tempe, Arizona, United States