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.
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 an inpatient unit during the Treatment Period. Blood samples will be collected periodically to assess the effect of CDX-301. Volunteers will be followed for safety for 28 days following the last dose. Any volunteer who develops anti-CDX-301 antibodies will be followed monthly until the antibody response is below the limit of detection. In general, the total duration of the study will be between approximately 33-38 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
CDX-301, administered in multiple dosages and frequencies depending on arm: n=3-6 at between 1-75 μg/kg over 5 days n=3-6 at 25 μg/kg over 7 days n=3-6 at 25 μg/kg over 10 days
Rockefeller University
New York, New York, United States
Number of reported adverse events
The number of adverse events along with the results of vital sign measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of CDX301.
Time frame: Until day 28 of follow up.
Determination of PK profile of CDX301
Levels of CDX301 in circulating blood will be evaluated by measures such as AUC, Cmax, T1/2, and Tmax
Time frame: Until day 28 of follow up or until resolution.
Immune system effects (eg: anti-CDX-301 antibody development, lymphoid cell populations, serum cytokines, and response to recall antigens and vaccination).
Time frame: Until day 28 of follow up
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