A Phase 1 Study Evaluating Safety and Tolerability of RCT2100 (in CF mRNA) in Healthy Participants and in Participants With CF

PHASE1RecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

February 1, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

March 30, 2026

Conditions
Cystic Fibrosis
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

Trial Locations (23)

10595

RECRUITING

New York Medical College, Valhalla

15213

RECRUITING

University of Pittsburgh, Pittsburgh

27599

RECRUITING

The University of North Carolina at Chapel Hill, Chapel Hill

30322

RECRUITING

Emory University, Atlanta

35294

RECRUITING

The University of Alabama at Birmingham, Birmingham

75390

RECRUITING

UT Southwestern Medical Center, Dallas

80206

RECRUITING

National Jewish Health, Denver

85719

RECRUITING

University of Arizona, Tucson

92037

RECRUITING

UCSD, San Diego

94304

RECRUITING

Stanford University, Palo Alto

97239

RECRUITING

Oregon Health & Science University, Portland

98195

RECRUITING

University of Washington, Seattle

02215

RECRUITING

Boston Children's Hospital, Boston

Unknown

RECRUITING

Centre Hospitalier Régional Universitaire de Montpellier - Hôpital Arnaud de Villeneuve, Montpellier

RECRUITING

Hôpital Necker Enfants Malades, Paris

RECRUITING

UMC Utrecht, Utrecht

COMPLETED

New Zealand Clinical Research (Part 1 Only), Auckland

RECRUITING

University Hospitals Birmingham, Birmingham

RECRUITING

Royal Papworth Hospital, Cambridge

RECRUITING

Leeds Teaching Hospitals, Leeds

RECRUITING

King's College Hospital, London

RECRUITING

Nottingham University Hospitals, Nottingham

RECRUITING

University Hospital Southampton, Southampton

Sponsors
All Listed Sponsors
lead

ReCode Therapeutics

INDUSTRY

NCT06237335 - A Phase 1 Study Evaluating Safety and Tolerability of RCT2100 (in CF mRNA) in Healthy Participants and in Participants With CF | Biotech Hunter | Biotech Hunter