A Phase I Study of CDX-622

NCT06650761 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CDX622-01
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Day 1 up to Day 127

Secondary Outcomes (3)

• CDX-622 serum evaluations over time

  Day 1 up to Day 127

• CDX-622 biomarker evaluations over time

  Day 1 up to Day 127

• Measurement of anti-drug antibody development over time

  Day 1 up to Day 127

Study Arms (2)

CDX-622

EXPERIMENTAL

Eligible participants will receive doses of CDX-622 by IV or SC

Drug: CDX-622

Normal Saline

PLACEBO COMPARATOR

Eligible participants will receive doses of Normal Saline by IV or SC

Drug: Normal Saline

Interventions

CDX-622 DRUG

Up to 4 infusions of one of seven dosages of CDX-622 or up to 1 dose by subcutaneous injection of one of three dosages of CDX-622

CDX-622

Normal Saline DRUG

Up to 4 infusions or 6 SC injections of normal saline

Normal Saline

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celldex Therapeutics: lead

Study Sites (1)

Celerion, Inc.

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: November 1, 2024
• Primary Completion: April 24, 2026
• Study Completion: April 24, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)