Phase 1 Cystic Fibrosis Trial, Recruiting NCT07035990 Sponsor: Sionna Therapeutics Inc. Condition: Cystic Fibrosis
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Phase 1 Cystic Fibrosis Trial, Recruiting

NCT07035990
Recruiting Phase 1 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults between 18 and 55 years old (inclusive) at the time of giving consent, who are generally healthy
  • People who weigh at least 45 kg and have a body mass index (BMI) between 18.0 and 32.0 at the screening visit
  • People who are willing to avoid alcohol, caffeine, smoking, and nicotine products for 72 hours before the study period and throughout the study, and to avoid certain foods (cruciferous vegetables such as broccoli and cabbage, charcoal-grilled meats, and poppy seeds) for 48 hours before dosing and throughout the study
  • People who have read, understood, and voluntarily signed a written consent form
  • People who are able and willing to follow all study procedures and rules throughout the trial

Who may not be able to join:

  • People who have, or have had, a significant illness affecting the heart, nervous system, lungs, liver, kidneys, metabolism, digestive system, urinary system, immune system, hormones, or mental health — as assessed by the trial doctor
  • People with a history of cancer, except for certain types of skin cancer that were fully removed with no signs of return for at least one year
  • People who have abnormal results on a heart tracing (ECG), physical examination, or vital signs check at the screening or pre-study visit, as judged by the trial doctor
  • People whose heart rhythm measurement (called QTcF) is above a certain level on any single reading — above 470 ms for females or above 450 ms for males — at screening or the pre-study visit
  • People who regularly drink more than 10 standard alcoholic drinks per week, smoke more than 10 cigarettes per week, or use recreational drugs more than once a month (the trial doctor may also exclude people with lower levels of use depending on their history and pattern of use)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Philip Ryan, MBBS, BMedSc, PhD, DPM, FFPM, Nucleus Network

Phone: 617-819-1389

Australian sites

Nucleus Network, Brisbane, Queensland
+61 (07) 3707 2720
Nucleus Network, Melbourne, Victoria
+61 (03) 8593 9801

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Sionna Therapeutics Inc.
Registry
ClinicalTrials.gov
Start date
23 July 2025
Est. completion
1 June 2026

Where this trial is recruiting

🇦🇺 Australia

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

To evaluate the incidence of treatment emergent adverse events [Safety and Tolerability] of SION-451 and SION-109 when administered in combination to healthy participants; To evaluate the incidence of treatment emergent adverse events [Safety and Tolerability] of SION-451 and SION-2222 when administered in combination to healthy participants

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov