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NCT07108153 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Cystic Fibrosis (CF), sponsored by Sionna Therapeutics.

Recruiting
Registry status
Phase 2
Development phase
16
Enrollment target
13
Study locations

NCT07108153 is a Phase 2 study of Cystic Fibrosis (CF) that is actively recruiting participants, run by Sionna Therapeutics. The registered enrollment target is 16 participants, below the 140-participant average among 14 other Cystic Fibrosis (CF) trials with a reported enrollment target (89% lower). The trial reports 13 study locations across 12 states.

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The verdict

NCT07108153, a Phase 2 study of Cystic Fibrosis (CF), is actively recruiting participants, sponsored by Sionna Therapeutics.

RECRUITING
Registry status
Phase 2
Development phase
16 participants
Enrollment target
13
Study locations

Study Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SION-719 when given to people with CF who are already taking Trikafta.

Conditions Studied

Interventions

  • DRUG SION-719
  • DRUG Placebo-to-match SION-719

Study Locations (13)

New York

  • New York Medical College - Hawthorne
  • Columbia University - New York

Colorado

  • National Jewish Health - Denver

Iowa

  • University of Iowa - Iowa City

Maryland

  • Johns Hopkins - Baltimore

Massachusetts

  • Boston Children's Hospital - Boston

Missouri

  • Washington University - St Louis

Ohio

  • University Hospital of Cleveland - Cleveland

South Carolina

  • Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2025-11-03
Est. Completion 2026-07
Phase Phase 2

Sponsor

Sionna Therapeutics

1 total trials

What the Registry Record Tells You About NCT07108153

The ClinicalTrials.gov registry entry for NCT07108153 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 140-participant average among 14 other Cystic Fibrosis (CF) trials with a reported enrollment target (89% lower). The listed sponsor is Sionna Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cystic Fibrosis (CF) appearing as the primary indexed condition, and to 2 interventions - of which SION-719 is the first listed.

NCT07108153 reports 13 study locations spanning 12 distinct geographic areas - top geographies include New York, Colorado, Iowa.

Frequently Asked Questions

What is clinical trial NCT07108153 about?

NCT07108153 is a clinical study titled "Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta". The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SION-719 when given to people with CF who are already taking Trikafta.

What is the current status of trial NCT07108153?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2025-11-03. Estimated completion is 2026-07.

What conditions does trial NCT07108153 study?

This clinical trial studies the following conditions: Cystic Fibrosis (CF).

What interventions are being tested in trial NCT07108153?

The interventions under investigation include: SION-719 (DRUG), Placebo-to-match SION-719 (DRUG).

Who is sponsoring clinical trial NCT07108153?

This trial is sponsored by Sionna Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07108153 being conducted?

This trial has 13 study locations across Colorado, Iowa, Maryland, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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