Phase 1/2 Trial of SP-101 for Cystic Fibrosis
This study is testing an investigational gene therapy called SP-101, given along with doxorubicin, for adults with Cystic Fibrosis (CF). This is a Phase 1/2 trial, meaning it's an early-stage study to see how safe the treatment is and how your body handles it. You might be able to join if you are between 18 and 65 years old, have CF, and cannot take or tolerate other CFTR modulator therapies. The study will look at any side effects you might have over 52 weeks to understand the safety of SP-101 and doxorubicin.
- Study design
- This is a Phase 1/2, open-label study, meaning you and your doctors will know what treatment you are receiving. It plans to enroll 15 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for 52 weeks after receiving the treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF)
At a glance
Conditions
Where it's being run
4 sites across 4 statesStudy leadership
- Jessica Lee, MPH · STUDY_DIRECTOR · Spirovant Sciences
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Incidence and severity of adverse events52 weeks
Safety and tolerability of SP-101 following a single inhalation dose, as assessed by incidence and severity of treatment emergent adverse events, serious adverse events, and dose limiting toxicities, including clinically significant changes from baseline to scheduled time points in safety parameters.