Actively Recruiting
A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF
Led by ReCode Therapeutics · Updated on 2026-01-16
192
Participants Needed
23
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is the first-in-human study with RCT2100 and is designed to provide safety and tolerability data for future clinical studies.
CONDITIONS
Official Title
A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 55 years with body weight ≥50 kg and BMI between 16-32 kg/m2
- Forced expiratory volume in one second (FEV1) of at least 80% predicted for healthy participants
- Good general health based on medical history, lab tests, vital signs, ECG, and physical exam
- Confirmed diagnosis of cystic fibrosis for CF participants
- FEV1 between 50% and 100% of predicted for CF participants
- Either not eligible for CFTR modulators due to mutations or eligible but intolerant or contraindicated
- Willing and able to understand and comply with study procedures
You will not qualify if you...
- Significant medical, surgical, or psychiatric conditions
- Supine blood pressure >150/90 mm Hg after rest for healthy participants
- Abnormal clinical lab tests at screening
- Current smokers or recent nicotine users (within 6 weeks) or heavy former smokers (>10 pack years)
- Hepatic cirrhosis with portal hypertension or moderate to severe hepatic impairment
- Acute respiratory infection, pulmonary exacerbation, or recent therapy changes within 4 weeks before dosing
- Lung infections linked to rapid decline in lung function
- Arterial oxygen saturation on room air less than 94% at screening
- Treatment with CFTR modulators within 12 weeks of screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of Arizona
Tucson, Arizona, United States, 85719
Actively Recruiting
3
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
4
UCSD
San Diego, California, United States, 92037
Actively Recruiting
5
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
6
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
Boston Children's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
8
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
9
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
10
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
11
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
12
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
13
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
14
Centre Hospitalier Régional Universitaire de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France
Actively Recruiting
15
Hôpital Necker Enfants Malades
Paris, France
Actively Recruiting
16
UMC Utrecht
Utrecht, Netherlands
Actively Recruiting
17
New Zealand Clinical Research (Part 1 Only)
Auckland, New Zealand
Completed
18
University Hospitals Birmingham
Birmingham, United Kingdom
Actively Recruiting
19
Royal Papworth Hospital
Cambridge, United Kingdom
Actively Recruiting
20
Leeds Teaching Hospitals
Leeds, United Kingdom
Actively Recruiting
21
King's College Hospital
London, United Kingdom
Actively Recruiting
22
Nottingham University Hospitals
Nottingham, United Kingdom
Actively Recruiting
23
University Hospital Southampton
Southampton, United Kingdom
Actively Recruiting
Research Team
P
Priya Ryali, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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