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New drug CDX-622 tested for safety in healthy people

NCT ID NCT06650761

Knowledge-focused Sponsor: Celldex Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 trial tested the safety of a new drug called CDX-622 in 85 healthy adults aged 18-55. Participants received either CDX-622 or a placebo (saline) by infusion or injection. The study measured side effects, drug levels in the blood, and immune responses. Since it involved healthy volunteers, there was no treatment benefit; the goal was to gather safety data for future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CDX-622
What could go wrong
This is an early safety study in healthy people, so it won't show if CDX-622 works for any disease. Side effects are possible, and the drug may not be effective in future trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

85 people

The number who actually took part.

Started

Nov 2024

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy participants

Contacts and locations

Locations

  • Celerion, Inc.

    Tempe, Arizona, 85283, United States

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