76
Participants
Start Date
August 24, 2018
Primary Completion Date
January 15, 2019
Study Completion Date
January 15, 2019
RJX
RJX is an IV infusion formulation. The appropriate RJX dose is calculated based on mL/kg. The administration dose is prepared by adding the appropriate RJX dose to 0.9% sterile saline such that a constant volume of 100 mL per IV infusion is obtained. Infusion time is 100 mL over 45 minutes (+/- 5 minutes).
Placebo
Matching placebo will be normal saline. To maintain the blind, a sleeve will cover the infusion bag and line such that the appearance will be identical to RJX administration.
ICON Early Phase Services, San Antonio
Collaborators (1)
ICON plc
INDUSTRY
ERT: Clinical Trial Technology Solutions
OTHER
Reven Pharmaceuticals, Inc.
INDUSTRY