NCT06526923

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

A Single Ascending Dose, Phase 1/2 Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of SP-101 Via Nebulizer for the Treatment of Cystic Fibrosis (CF)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Spirovant Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This multi-center study is a first-in-human, single ascending dose, Phase 1/2 trial to evaluate the safety, pharmacokinetics, and pharmacodynamics of various dose levels in people with CF who are ineligible or intolerant to CFTR modulator therapy.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	SP-101 and doxorubicin Cohort 1	Single inhaled dose of SP-101 and doxorubicin Dose 1
COMBINATION_PRODUCT	SP-101 and doxorubicin Cohort 2	Single inhaled dose of SP-101 and doxorubicin Dose 2

Timeline

• Start date: 2024-09-16
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-07-30
• Last updated: 2024-11-25

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study