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A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF

NCT06237335 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2026-01-16

No results posted yet for this study

Summary

This is the first-in-human study with RCT2100 and is designed to provide safety and tolerability data for future clinical studies.

Conditions

Interventions

DRUG

RCT2100

RCT2100 supplied as varying dose strengths administered via oral inhalation using nebulizer

OTHER

Placebo

Placebo of similar volumes to experimental dose strengths administered via oral inhalation using nebulizer

DRUG

RCT2100

RCT2100 supplied as varying dose strengths administered via oral inhalation using nebulizer for 4 weeks

DRUG

RCT2100

RCT2100 supplied at a single dose strength administered via oral inhalation using nebulizer for 12 weeks

DRUG

Ivacaftor

ivacaftor administered orally for 6 weeks

DRUG

RCT2100

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

Sponsors & Collaborators

  • ReCode Therapeutics

    lead INDUSTRY

Principal Investigators

  • John Matthews, MBBS, MCRP, PhD · ReCode Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2026-08-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • France
  • Netherlands
  • New Zealand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06237335 on ClinicalTrials.gov