NCT01465139

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

A Phase 1 Safety, Pharmacokinetic, and Immunologic Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Celldex Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 response for approximately one month or more.

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 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CDX-301	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

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-11-01
• Completion: 2013-01-01
• First posted: 2011-11-04
• Last updated: 2017-06-27

Locations

1 site across 1 country: United States