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NCT06429176 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients with Cystic Fibrosis
A Phase 2 study of Cystic Fibrosis, sponsored by SpliSense.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT06429176: Recruiting Phase 2 study of Cystic Fibrosis, sponsored by SpliSense.
NCT06429176 is a Phase 2 study of Cystic Fibrosis that is actively recruiting participants, run by SpliSense. The registered enrollment target is 24 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06429176, a Phase 2 study of Cystic Fibrosis, is actively recruiting participants, sponsored by SpliSense.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this clinical trial is to learn if drug SPL84 is safe for adult patients with cystic fibrosis (CF). It will also learn if the drug works to treat works to treat CF with a specific mutation. The purpose of this research study is to: * test the safety and effectiveness of multiple doses of the study drug, SPL84 * test how multiple doses of the drug are processed by the body Researchers will compare drug SPL84 to a placebo (a look-alike substance that contains no drug) to see if drug SPL84 is safe and if it works to treat CF. Participants will: Take drug SPL84 or a placebo by inhalation every week for 9 weeks months Visit the clinic approximately 14 times over 17.5 weeks for checkups and tests
Primary Outcome
Incidence, nature, and severity of AEs and SAEs
Conditions Studied
Interventions
- OTHER Placebo
- DRUG SPL84
Study Locations (2)
Massachusetts
- Boston Children'S Hospital - Boston
Ohio
- Nationwide Children'S Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-06-24 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What NCT06429176 shows while recruiting
NCT06429176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06429176 reports a single indexed study location in Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT06429176 about?
NCT06429176 is a clinical study titled "Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients with Cystic Fibrosis". The goal of this clinical trial is to learn if drug SPL84 is safe for adult patients with cystic fibrosis (CF). It will also learn if the drug works to treat works to treat CF with a specific mutation. The purpose of this research study is to: * test the safety and effectiveness of multiple doses ...
What is the current status of trial NCT06429176?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2024-06-24. Estimated completion is 2025-12-31.
What conditions does trial NCT06429176 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT06429176?
The interventions under investigation include: Placebo (OTHER), SPL84 (DRUG).
Who is sponsoring clinical trial NCT06429176?
This trial is sponsored by SpliSense, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06429176 being conducted?
This trial has 2 study locations across Massachusetts, Ohio. 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 NCT06429176's enrollment target sits among peer trials
24 123rd of 169 higher than 45 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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