Status:
COMPLETED
A Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers
Lead Sponsor:
Celldex Therapeutics
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
A total of seven cohorts of healthy volunteers are planned with doses of CDX-301 (rhuFlt3L) ranging between 1 and 75 μg/kg and dosing durations between 5 and 10 days. Volunteers will be admitted to a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01465139
Start Date
October 1 2011
End Date
January 1 2013
Last Update
June 27 2017
Active Locations (1)
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1
Rockefeller University
New York, New York, United States, 10065