A Phase I Study of CDX-622

Description

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

Conditions

Healthy Participants

Study Overview

Study Details

Study overview

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

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

A Phase I Study of CDX-622

Condition
Healthy Participants
Intervention / Treatment

-

Contacts and Locations

Tempe

Celerion, Inc., Tempe, Arizona, United States, 85283

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Celldex Therapeutics,

Study Record Dates

2025-11