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NCT06526923 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF)
A Phase 1 study of Cystic Fibrosis, sponsored by Spirovant Sciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 4
- Study locations
NCT06526923: Recruiting Phase 1 study of Cystic Fibrosis, sponsored by Spirovant Sciences.
NCT06526923 is a Phase 1 study of Cystic Fibrosis that is actively recruiting participants, run by Spirovant Sciences. The registered enrollment target is 15 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (92% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06526923, a Phase 1 study of Cystic Fibrosis, is actively recruiting participants, sponsored by Spirovant Sciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
Safety and tolerability of SP-101 following a single inhalation dose, as assessed by incidence and severity of treatment emergent adverse events, serious adverse events, and dose limiting toxicities, including clinically significant changes from baseline to scheduled time points in safety parameters.
Conditions Studied
Interventions
- COMBINATION_PRODUCT SP-101 and doxorubicin Cohort 1
- COMBINATION_PRODUCT SP-101 and doxorubicin Cohort 2
Study Locations (4)
Kansas
- University of Kansas Medical Center - Kansas City
Massachusetts
- Boston Children's Hospital, Brigham & Women's Hospital - Boston
New York
- Columbia University - New York
Pennsylvania
- Hospital at University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-09-16 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT06526923 shows while recruiting
NCT06526923 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which SP-101 and doxorubicin Cohort 1 is the first listed.
NCT06526923 reports a single indexed study location in Kansas, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT06526923 about?
NCT06526923 is a clinical study titled "A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF)". 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.
What is the current status of trial NCT06526923?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2024-09-16. Estimated completion is 2026-12-31.
What conditions does trial NCT06526923 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT06526923?
The interventions under investigation include: SP-101 and doxorubicin Cohort 1 (COMBINATION_PRODUCT), SP-101 and doxorubicin Cohort 2 (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06526923?
This trial is sponsored by Spirovant Sciences, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06526923 being conducted?
This trial has 4 study locations across Kansas, Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06526923's enrollment target sits among peer trials
15 145th of 169 higher than 22 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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