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
Location: See all (4) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
United States
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Boston Children's Hospital, Brigham & Women's Hospital
RECRUITING
Boston
New York
Columbia University
RECRUITING
New York
Pennsylvania
Hospital at University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Spirovant.ClinicalTrials
clinicaltrials@spirovant.com
(267) 805-6747
Time Frame
Start Date: 2024-09-16
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 15
Treatments
Experimental: Cohort 1
Single inhalational administration of SP-101 and doxorubicin Dose 1
Experimental: Cohort 2
Single inhalational administration of SP-101 and doxorubicin Dose 2
Experimental: Dose Expansion
Single inhalational administration of SP-101 and doxorubicin Selected Dose
Related Therapeutic Areas
Sponsors
Leads: Spirovant Sciences, Inc.