Phase 2 Cystic Fibrosis Trial, Recruiting NCT06237335 Sponsor: ReCode Therapeutics Condition: Cystic Fibrosis
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Phase 2 Cystic Fibrosis Trial, Recruiting

NCT06237335
Recruiting Phase 2

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:

Part 1 (Healthy Volunteers):

  • You are a healthy adult (male or female) between 18 and 55 years old
  • You weigh at least 50 kg and your Body Mass Index (BMI) falls between 16 and 32
  • Your lung function test shows your lungs are working at least 80% as well as expected for someone your age and size
  • A doctor has reviewed your health history, blood tests, heart tracing, and physical exam and considers you to be in good general health
  • You understand and are willing to follow all study procedures as outlined in the consent form

Parts 2 & 3 (People with Cystic Fibrosis):

  • You have a confirmed diagnosis of Cystic Fibrosis (CF)
  • Your lung function is between 50% and 100% of what is expected for your age, sex, and height
  • You have CF gene mutations on both copies of the gene that do not respond to CFTR modulator treatments, OR you are eligible for CFTR modulator treatments but cannot take them due to side effects or medical reasons that prevent their use

Who may not be able to join:

Part 1 (Healthy Volunteers):

  • You have a significant medical, surgical, or mental health condition, either currently or in the past
  • Your blood pressure while lying down is higher than 150 (top number) or 90 (bottom number) after resting for at least 5 minutes
  • Your blood test results at the screening visit come back abnormal
  • You currently smoke, use nicotine products, or have done so in the past 6 weeks, or you are a former smoker with a long history of heavy smoking (more than 10 "pack years")

Parts 2 & 3 (People with Cystic Fibrosis):

  • You have serious liver disease with complications, or moderate to severe liver damage (confirm with trial site)
  • You have had a chest or airway infection, a worsening of your lung symptoms, or a change in your lung-related medicines (including antibiotics) in the 4 weeks before starting the study
  • You currently have a lung infection caused by certain bacteria known to cause faster lung decline (confirm with trial site)
  • The level of oxygen in your blood measured without any oxygen support is below 94% at your screening visit
  • You have taken a CF modulator medicine such as Kalydeco, Trikafta, Symdeko, Orkambi, or Alyftrek within the 12 weeks before your screening visit

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 27 July 2026
Phase 2: approximately ~30% 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: John Matthews, MBBS, MCRP, PhD, ReCode Therapeutics, Inc.

Phone: 650-629-7900

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 2
Sponsor
ReCode Therapeutics
Registry
ClinicalTrials.gov
Start date
1 February 2024
Est. completion
30 August 2026

Where this trial is recruiting

🇫🇷 France 🇳🇱 Netherlands 🇳🇿 New Zealand 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Part 1: The number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs).; Part 2: The number of participants with CF with AEs and SAEs.; Part 3: The number of participants with CF with AEs and SAEs.

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: 27 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