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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
ReCode Therapeutics
Study ID
NCT06237335
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • RCT2100 — DRUG
    RCT2100 supplied as varying dose strengths administered via oral inhalation using nebulizer
  • Placebo — OTHER
    Placebo of similar volumes to experimental dose strengths administered via oral inhalation using nebulizer
  • RCT2100 — DRUG
    RCT2100 supplied as varying dose strengths administered via oral inhalation using nebulizer for 4 weeks
  • RCT2100 — DRUG
    RCT2100 supplied at a single dose strength administered via oral inhalation using nebulizer for 12 weeks
  • Ivacaftor — DRUG
    ivacaftor administered orally for 6 weeks
  • RCT2100 — DRUG
    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

Study Details

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

Key Dates

Start date
Feb 1, 2024
Status verified
Jan 2026
Primary completion
Aug 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
192 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RCT2100 (Part 1)
    RCT2100 single dose
  • Placebo Comparator: Placebo (Part 1)
    Placebo single dose
  • Experimental: RCT2100 (Part 2) 4 week
    RCT2100 multiple dose
  • Experimental: RCT2100 (Part 2) 12 week
    RCT2100 multiple dose
  • Experimental: Experimental: RCT2100 (Part 3) 6 week
    RCT2100 multiple dose

Primary Outcome Measure

Part 1: The number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs). [ Time Frame: From Baseline Through Day 29 ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
The University of Alabama at BirminghamBirminghamAlabama35294-
University of ArizonaTucsonArizona85719-
Stanford UniversityPalo AltoCalifornia94304-
UCSDSan DiegoCalifornia92037-
National Jewish HealthDenverColorado80206-
Emory UniversityAtlantaGeorgia30322-
Boston Children's HospitalBostonMassachusetts02215-
New York Medical CollegeValhallaNew York10595-
The University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Oregon Health & Science UniversityPortlandOregon97239-
University of PittsburghPittsburghPennsylvania15213-
UT Southwestern Medical CenterDallasTexas75390-
University of WashingtonSeattleWashington98195-

Find similar trials in Birmingham, AL

By research site
The University of Alabama at Birmingham· Birmingham, ALUniversity of Arizona· Tucson, AZStanford University· Palo Alto, CAUCSD· San Diego, CANational Jewish Health· Denver, COEmory University· Atlanta, GA

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