A Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers
|ClinicalTrials.gov Identifier: NCT01465139|
Recruitment Status : Completed
First Posted : November 4, 2011
Last Update Posted : June 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: CDX-301||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Safety, Pharmacokinetic, and Immunologic Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||January 2013|
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
- Number of reported adverse events [ Time Frame: Until day 28 of follow up. ]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. ]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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465139
|United States, New York|
|New York, New York, United States, 10065|