RecruitingPhase 1/2

A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF)

United States15 participantsStarted 2024-09-16

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Males or females, age 18 to 65 years at Screening Visit, inclusive
✓. Diagnosis of CF
✓. ppFEV1 value between 50-100% (inclusive)
✓. 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

Exclusion criteria

✕. 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.
✕. 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
✕. Lung infection with Mycobacterium abscessus associated with a more rapid decline in pulmonary status
✕. Currently receiving treatment for active lung infection with Burkholderia cenocepacia or Burkholderia dolosa
✕. History of solid organ or hematological transplantation
✕. History of clinically significant cirrhosis with or without portal hypertension
✕. History of pulmonary hypertension
✕. History of cardiotoxicity, a history of known coronary artery disease, and/or existing cardiomyopathy

What they're measuring

Incidence and severity of adverse events

Timeframe: 52 weeks

Trial details

NCT IDNCT06526923

SponsorSpirovant Sciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Spirovant.ClinicalTrials

(267) 805-6747 clinicaltrials@spirovant.com

View on ClinicalTrials.gov More Cystic Fibrosis trials