A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF
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
ReCode Therapeutics
192 participants
Feb 1, 2024
INTERVENTIONAL
Conditions
Summary
This is the first-in-human study with RCT2100 and is designed to provide safety and tolerability data for future clinical studies.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
RCT2100 supplied as varying dose strengths administered via oral inhalation using nebulizer
Placebo of similar volumes to experimental dose strengths administered via oral inhalation using nebulizer
RCT2100 supplied as varying dose strengths administered via oral inhalation using nebulizer for 4 weeks
RCT2100 supplied at a single dose strength administered via oral inhalation using nebulizer for 12 weeks
ivacaftor administered orally for 6 weeks
RCT2100 supplied at varying dose strengths. Co- administered via oral inhalation using nebulizer for 4 weeks with ivacaftor after initial 2 weeks of ivacaftor dosing run in period
Locations(23)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06237335