🏛️ Verified NIH Record • Updated 2026-08-17
A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF (NCT06237335)
A Phase 1/2, Multicenter Study Evaluating the Safety, Tolerability, and Biodistribution of RCT2100 With Single-Ascending Doses in Healthy Participants and Multiple-Ascending Doses and Proof-of-Concept in Participants With Cystic Fibrosis
🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: ReCode Therapeutics
🩺 Plain-English Summary (8th-Grade Level)
This is the first-in-human study with RCT2100 and is designed to provide safety and tolerability data for future clinical studies.
Who can join: Review the eligibility criteria below.
Location: The University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years to 60 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (23 Sites)
- The University of Alabama at Birmingham — Birmingham, Alabama
- University of Arizona — Tucson, Arizona
- Stanford University — Palo Alto, California
- UCSD — San Diego, California
- National Jewish Health — Denver, Colorado
- Emory University — Atlanta, Georgia
- Boston Children's Hospital — Boston, Massachusetts
- New York Medical College — Valhalla, New York
- The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
- Oregon Health & Science University — Portland, Oregon
- University of Pittsburgh — Pittsburgh, Pennsylvania
- UT Southwestern Medical Center — Dallas, Texas
- University of Washington — Seattle, Washington
- Centre Hospitalier Régional Universitaire de Montpellier - Hôpital Arnaud de Villeneuve — Montpellier,
- Hôpital Necker Enfants Malades — Paris,
- UMC Utrecht — Utrecht,
- New Zealand Clinical Research (Part 1 Only) — Auckland,
- University Hospitals Birmingham — Birmingham,
- Royal Papworth Hospital — Cambridge,
- Leeds Teaching Hospitals — Leeds,
- King's College Hospital — London,
- Nottingham University Hospitals — Nottingham,
- University Hospital Southampton — Southampton,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Cystic Fibrosis
- Genetic Modifiers of Cystic Fibrosis (CF) Liver Disease — Chapel Hill, North Carolina
- Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age — Orange, California
- Hyperpolarized Imaging for New Treatments — Cincinnati, Ohio
- Monitoring Response to Orkambi in Cystic Fibrosis Lung Disease by Inhaled Xenon MRI — Cincinnati, Ohio
- Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older — Nedlands,
- Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis — Cincinnati, Ohio
Explore by condition: All Cystic Fibrosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.