RecruitingCystic Fibrosis
A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF)
Eligible age
18–65 yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
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About this study
This is a Phase 1/2 multicenter, open-label, single dose trial of SP-101 investigational gene therapy in adults with CF who are ineligible for or intolerant to CFTR modulator therapy.
Sponsor: Spirovant Sciences, Inc.
You may qualify if…
- ✓ 1. Males or females, age 18 to 65 years at Screening Visit, inclusive
- ✓ 2. Diagnosis of CF
- ✓ 3. ppFEV1 value between 50-100% (inclusive)
- ✓ 4. Resting oxygen saturation ≥94% on room air by pulse oximetry 5 . Clinically stable CF disease as assessed by the Investigator and not requiring any new class of interventional treatment within the last 3 months prior to Screening
You may not qualify if…
- ✕ 1. Any change in established pulmonary treatment (including antibiotics) within 28 days prior to Screening Visit. However, inhaled beta-agonists can be included within 2 weeks prior to Screening Visit.
- ✕ 2. Clinically significant episode of hemoptysis (\>50 mL or ¼ cup or 10 teaspoons per day) within 12 weeks prior to dosing with study drug on Day 1
- ✕ 3. Lung infection with Mycobacterium abscessus associated with a more rapid decline in pulmonary status
- ✕ 4. Currently receiving treatment for active lung infection with Burkholderia cenocepacia or Burkholderia dolosa
- ✕ 5. History of solid organ or hematological transplantation
- ✕ 6. History of clinically significant cirrhosis with or without portal hypertension
- ✕ 7. History of pulmonary hypertension
- ✕ 8. History of cardiotoxicity, a history of known coronary artery disease, and/or existing cardiomyopathy
Where it's recruiting
Source: ClinicalTrials.gov · NCT06526923 · last updated 2024-11-25