Phase 1 Cystic Fibrosis Trial, Recruiting NCT07709494 Sponsor: Revagenix, Inc. Condition: Cystic Fibrosis
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Phase 1 Cystic Fibrosis Trial, Recruiting

NCT07709494
Recruiting Phase 1

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:

For healthy participants:

  • Men and women between 18 and 55 years old who are in good general health
  • People with a body mass index (a measure of body weight relative to height) between 18 and 32
  • People whose lungs are working at 80% or more of the expected level, based on a breathing test
  • People whose kidneys are filtering at a normal rate (90 mL/min or above)
  • People whose blood tests and physical check-up results are normal, or only slightly outside the normal range in a way that is not medically concerning

For patients with a lung condition called non-cystic fibrosis bronchiectasis (NCFB) and a specific bacterial infection:

  • Men and women between 18 and 80 years old with a confirmed diagnosis of bronchiectasis (a condition where the airways are permanently widened and damaged)
  • People whose bronchiectasis has been confirmed by a CT scan
  • People with a long-term infection caused by a bacterium called Pseudomonas aeruginosa, shown by two or more positive test results in the past 12 months
  • People whose sputum (mucus coughed up from the lungs) tests positive for Pseudomonas aeruginosa at a certain level at the screening stage
  • People whose lungs are working at 50% or more of the expected level after using a breathing-opening medication

Who may not be able to join:

For healthy participants:

  • People with a significant medical history of illness or health conditions
  • People who have had an acute (sudden) illness in the 4 weeks before screening
  • People who currently smoke or use nicotine products
  • People with a history of alcohol or drug misuse in the past 12 months

For patients with NCFB and Pseudomonas aeruginosa infection:

  • People whose primary lung condition is asthma, chronic obstructive pulmonary disease (COPD), or cystic fibrosis
  • People who have needed intravenous (IV) antibiotics for more than two lung flare-ups in the past 12 months
  • People who have taken antibiotics (other than a specific type called macrolides) in the 30 days before screening
  • People who have had significant coughing up of blood that required medical treatment in the 30 days before screening
  • People currently receiving treatment for a separate lung infection caused by certain bacteria (called nontuberculous mycobacteria) or a fungal infection

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

Phone: 619-512-3538

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

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Revagenix, Inc.
Registry
ClinicalTrials.gov
Start date
13 July 2026
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence and severity of treatment-emergent adverse events (AEs); Number of participants with clinically significant abnormalities in lab parameters, vital signs, respiratory function, and ECG parameters graded by FDA Toxicity Grading Scale (for healthy participants) and DAIDS Toxicity Tables (for NCFB patients)

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