A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF
Start Date
2/1/2024
Completion Date
12/31/2026
Summary
This is the first-in-human study with RCT2100 and is designed to provide safety and tolerability data for future clinical studies.
Detailed Description
This is a multi-part study to assess the safety, tolerability, and biodistribution of a single ascending dose of inhaled RCT2100 administered via nebulizer to healthy participants (Part 1), the safety and tolerability of multiple-ascending doses of inhaled RCT2100 administered to participants with CF (Part 2), and the safety and tolerability of RCT2100 co-administered with ivacaftor in participants with CF (Part 3).
Eligibility Criteria
Age Range: 18 years to 60 years
Interventions
RCT2100
Placebo
RCT2100
RCT2100
Ivacaftor
RCT2100
Conditions
Locations
The University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
University of Arizona
Tucson, Arizona 85719
United States
Stanford University
Palo Alto, California 94304
United States
UCSD
San Diego, California 92037
United States
National Jewish Health
Denver, Colorado 80206
United States
Emory University
Atlanta, Georgia 30322
United States
Boston Children's Hospital
Boston, Massachusetts 02215
United States
New York Medical College
Valhalla, New York 10595
United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
University of Pittsburgh
Pittsburgh, Pennsylvania 15213
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
University of Washington
Seattle, Washington 98195
United States
Centre Hospitalier Régional Universitaire de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier,
France
Hôpital Necker Enfants Malades
Paris,
France
UMC Utrecht
Utrecht,
Netherlands
New Zealand Clinical Research (Part 1 Only)
Auckland,
New Zealand
University Hospitals Birmingham
Birmingham,
United Kingdom
Royal Papworth Hospital
Cambridge,
United Kingdom
Leeds Teaching Hospitals
Leeds,
United Kingdom
King's College Hospital
London,
United Kingdom
Nottingham University Hospitals
Nottingham,
United Kingdom
University Hospital Southampton
Southampton,
United Kingdom