🏛️ 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

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full 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.

Explore by condition: All Cystic Fibrosis clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗