RECRUITING

A Phase I Study of CDX-622

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Two-Part, Phase 1a Dose Escalation Clinical Trial to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-622 in Healthy Participants

Quick Facts

Study Start:2024-11-01

Study Completion:2025-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06650761

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Celldex Therapeutics

CONTACT

844-723-9363

clinicaltrials@celldex.com

Study Locations (Sites)

Celerion, Inc.

Tempe, Arizona, 85283

United States

Collaborators and Investigators

Sponsor: Celldex Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01

Study Completion Date2025-11

Study Record Updates

Study Start Date2024-11-01

Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

Healthy Participants