Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Cystic Fibrosis (CF)
Interventions
DRUG

SION-719

All participants receive SION-719, as specified by their treatment sequence assignment

DRUG

Placebo-to-match SION-719

All participants receive placebo to match SION-719, as specified by their treatment sequence assignment

Trial Locations (13)

2050

Royal Prince Alfred Hospital, Camperdown

3004

Monash University, Melbourne

4215

Gold Coast University Hospital, Southport

10032

Columbia University, New York

10532

New York Medical College, Hawthorne

21205

Johns Hopkins, Baltimore

29425

Medical University of South Carolina, Charleston

44106

University Hospital of Cleveland, Cleveland

52242

University of Iowa, Iowa City

63110

Washington University, St Louis

80206

National Jewish Health, Denver

98195

University of Washington, Seattle

02115

Boston Children's Hospital, Boston

All Listed Sponsors
lead

Sionna Therapeutics Inc.

INDUSTRY

NCT07108153 - Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta | Biotech Hunter | Biotech Hunter