A Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

CDX-301 is a protein that stimulates the growth of bone marrow stem cells and certain immune cells. This study is testing CDX-301 in healthy volunteers who will be monitored for safety and biological response for approximately one month or more.

Key facts

Study ID

NCT01465139

Run by

Celldex Therapeutics

People needed

30

Starts

2011-10-01

Expected to finish

2013-01-01

Last updated by the study team

2017-06-27

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Among other criteria, volunteers must meet the following conditions to be eligible for the study:
• Ages 18 - 55
• Body Weight ≤ 120 kg
• Generally good health and without significant medical conditions
• Willing to use effective method of contraception
• Abstinence from alcohol for 72 hours prior to study drug administration and throughout the study
• Negative screening test for HIV, hepatitis B, and hepatitis C
• Provide written informed consent

You may not qualify if…

• Among other criteria, volunteers who meet the following conditions are NOT eligible for the study:
• Drug or alcohol abuse within 12 months
• Positive drug screen
• Receipt of certain types of experimental drugs or other treatments, or certain medications
• Use of systemic immunosuppressive agents (excluding topical steroids) within 12 months
• History of certain diseases including syphilis, herpes zoster, primary or secondary immunodeficiency
• Diagnosis with or family history of significant autoimmunity (ex: type I diabetes, multiple sclerosis, rheumatoid arthritis, scleroderma)
• Any history of cancer, excluding adequately treated and cured basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ within 2 years
• History of asthma requiring any use of inhaled or oral medication within 5 years
• Herpes zoster within 3 months
• Donation of blood within 8 weeks, and donation of plasma within 2 weeks

Where it is running

• Rockefeller University — New York, New York, United States

Full record on ClinicalTrials.gov

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