A Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Phase 1 Safety, Pharmacokinetic, and Immunologic Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers|
- Number of reported adverse events [ Time Frame: Until day 28 of follow up. ] [ Designated as safety issue: Yes ]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.
- Determination of PK profile of CDX301 [ Time Frame: Until day 28 of follow up or until resolution. ] [ Designated as safety issue: Yes ]Levels of CDX301 in circulating blood will be evaluated by measures such as AUC, Cmax, T1/2, and Tmax
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Study Completion Date:||January 2013|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
CDX-301 (rhuFlt3L), administered to healthy patients.
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
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.