MedTrace Logo

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

NCT03680105 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2020-04-27

Study results available
· View outcomes & findings →

Summary

Designed as a single center, two-part, double-blind, placebo-controlled, randomized study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RJX in healthy participants.

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.

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • ERT: Clinical Trial Technology Solutions

    collaborator OTHER

  • Reven Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Dennis A Ruff, MD · ICON Early Phase Services

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-24
Primary Completion
2019-01-15
Completion
2019-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03680105 on ClinicalTrials.gov