RecruitingPhase 1Phase 2NCT06526923

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)


Sponsor

Spirovant Sciences, Inc.

Enrollment

15 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying SP-101 and doxorubicin Cohort 1 and SP-101 and doxorubicin Cohort 2 for people with cystic fibrosis. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTSP-101 and doxorubicin Cohort 1

Single inhaled dose of SP-101 and doxorubicin Dose 1

COMBINATION_PRODUCTSP-101 and doxorubicin Cohort 2

Single inhaled dose of SP-101 and doxorubicin Dose 2


Locations(4)

University of Kansas Medical Center

Kansas City, Kansas, United States

Boston Children's Hospital, Brigham & Women's Hospital

Boston, Massachusetts, United States

Columbia University

New York, New York, United States

Hospital at University of Pennsylvania

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06526923


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