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

NCT06526923 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-11-25

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Spirovant Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Jessica Lee, MPH · Spirovant Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-16
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06526923 on ClinicalTrials.gov