A Safety and Tolerability Study of RJX Drug Product in Healthy Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

August 24, 2018

Primary Completion Date

January 15, 2019

Study Completion Date

January 15, 2019

Conditions
Critical Limb Ischemia
Interventions
DRUG

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).

DRUG

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.

Trial Locations (1)

78209

ICON Early Phase Services, San Antonio

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ICON plc

INDUSTRY

collaborator

ERT: Clinical Trial Technology Solutions

OTHER

lead

Reven Pharmaceuticals, Inc.

INDUSTRY

NCT03680105 - A Safety and Tolerability Study of RJX Drug Product in Healthy Participants | Biotech Hunter | Biotech Hunter