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NCT06237335

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

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved at least 2 months later, enrollment reduced 33%.

See at-risk trials from ReCode Therapeutics

Track this trial

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Record History

All 35 versions: 32 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 192 → 128 participantsv35 Show 4 more changesShow less
    • Enrollment closed, study ongoing
    • Primary completion pushed from Aug 30, 2026 to Nov 2026
    • Study completion moved earlier from Dec 31, 2026 to Nov 2026
    • Site details revised at 23 of 23 sites
  2. Eligibility criteria revisedv34
  3. Phase: Phase 1 to Phase 2v33 Show 9 more changesShow less
    • Primary completion date: Dec 31, 2025 to Aug 30, 2026
    • Eligibility criteria expanded, about 179 words
    • Primary endpoints: 2 to 3
    • Enrollment target: 180 to 192
    • Study completion date: Mar 30, 2026 to Dec 31, 2026
    • Interventions: Placebo (Other), RCT2100 (Drug), RCT2100 (Drug), RCT2100 (Drug) to Ivacaftor (Drug), Placebo (Other), RCT2100 (Drug), RCT2100 (Drug), RCT2100 (Drug), RCT2100 (Drug)
    • Study description expanded, about 20 words
    • Study arms: 4 to 5
    • Study title shortened, about 1 word
  4. Study title expanded, about 3 wordsv32
  5. Eligibility criteria shortened, about 10 words
    • Enrollment target: 158 to 180
    v31
Show 26 earlier versionsHide 26 earlier versions
  1. Site details revised at 2 of 23 sitesv30
  2. Site details revised at 1 of 23 sitesv29
  3. Site details revised at 1 of 23 sitesv28
  4. Site details revised at 1 of 23 sitesv27
  5. Site details revised at 1 of 23 sitesv26
  6. Site details revised at 1 of 23 sitesv25
  7. Site details revised at 1 of 23 sitesv24
  8. Site details revised at 1 of 23 sitesv23
  9. Site details revised at 1 of 23 sitesv22
  10. Enrollment target: 100 to 158v21 Show 6 more changesShow less
    • Primary completion date: Apr 30, 2025 to Dec 31, 2025
    • Eligibility criteria expanded, about 4 words
    • Study sites: 24 to 23
    • Study completion date: Dec 2, 2025 to Mar 30, 2026
    • Interventions: Placebo (Other), RCT2100 (Drug) to Placebo (Other), RCT2100 (Drug), RCT2100 (Drug), RCT2100 (Drug)
    • Study arms: 3 to 4
  11. Site details revised at 1 of 24 sitesv20
  12. Site details revised at 1 of 24 sitesv19
  13. Site details revised at 1 of 24 sitesv18
  14. Site details revised at 2 of 24 sitesv17
  15. Site details revised at 1 of 24 sitesv16
  16. Site details revised at 1 of 24 sitesv15
  17. Site details revised at 1 of 24 sitesv14
  18. Site details revised at 1 of 24 sitesv13
  19. Site details revised at 1 of 24 sitesv12
  20. Site details revised at 2 of 24 sitesv11
  21. Study sites revised (24)v9
  22. Site details revised at 1 of 24 sitesv8
  23. Phase: Phase 1/2 to Phase 1v7 Show 8 more changesShow less
    • Enrollment target: 32 to 100
    • Primary completion date: Sep 30, 2024 to Apr 30, 2025
    • Eligibility criteria expanded, about 186 words
    • Primary endpoints: 1 to 2
    • Study sites: 1 to 24
    • Study description expanded, about 13 words
    • Study arms: 2 to 3
    • Study title expanded, about 5 words
  24. Phase: Phase 1 to Phase 1/2
    • Primary completion date: May 17, 2024 to Sep 30, 2024
    • Study completion date: Aug 17, 2024 to Dec 2, 2025
    v6
  25. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  26. Study title shortened, about 2 wordsv2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Part 1: The number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs).
Timeframe: From Baseline Through Day 29
Part 2: The number of participants with CF with AEs and SAEs.
Timeframe: From Day 1 through Safety Follow-up, Week 24
Part 3: The number of participants with CF with AEs and SAEs.
Timeframe: From Day 1 through Safety Follow-up, Week 24

Arms and interventions

RCT2100 (Part 1)Experimental

RCT2100 single dose

Placebo (Part 1)Placebo comparator

Placebo single dose

RCT2100 (Part 2) 4 weekExperimental

RCT2100 multiple dose

RCT2100 (Part 2) 12 weekExperimental

RCT2100 multiple dose

Experimental: RCT2100 (Part 3) 6 weekExperimental

RCT2100 multiple dose

Drugs: RCT2100, Ivacaftor

Other: Placebo

Sites

23 sites in 5 countries

United States 13, United Kingdom 6, France 2, Netherlands 1, New Zealand 1