Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients With Cystic Fibrosis

ClinicalTrials.gov ID: NCT06429176

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Official title

A Phase 2a, Randomized, Placebo-Controlled, Double Blind Multiple Ascending Dose Study in Patients With Cystic Fibrosis Carrying the 3849 +10 Kb C->T Mutation to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 (3849 +10kb C--\>T). The purpose of this research study is to test the safety and effectiveness of multiple doses of the study drug, SPL84. 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. In cohorts 1-3, SPL84 will be tested as a monotherapy, and in Cohort 4, SPL84 will be tested in participants who are already stable on CFTR modulator therapy. Participants will take drug SPL84 or a placebo by inhalation every week for 9 weeks (cohorts 1-3) or 12 weeks (cohort 4) and visit the clinic approximately weekly for checkups and tests.

Study identification

NCT ID: NCT06429176
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: SpliSense Ltd.; Industry
Enrollment: 64 participants

Conditions and interventions

Conditions

Cystic Fibrosis

Interventions

SPL84 Drug
Placebo Other

Drug · Other

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 24, 2024 (Actual)
Primary completion: Oct 1, 2027 (Estimated)
Completion: Dec 31, 2027 (Estimated)
Last update posted: Nov 10, 2026

2024 – 2027

United States locations

U.S. sites: 16
U.S. states: 12
U.S. cities: 15

Facility	City	State	ZIP	Site status
Memorial Care Long Beach Medical Center	Long Beach	California	90806	Recruiting
University of Southern California	Los Angeles	California	90033	Recruiting
University of California, San Francisco	San Francisco	California	94143	Recruiting
University of California Los Angeles	Santa Monica	California	90404	Not yet recruiting
National Jewish Health	Denver	Colorado	80206	Recruiting
Joe DiMaggio Children's Hospital	Hollywood	Florida	33021	Not yet recruiting
Northwestern University	Chicago	Illinois	60611	Not yet recruiting
Boston Children'S Hospital	Boston	Massachusetts	02115	Recruiting
University of Minnesota	Minneapolis	Minnesota	55455	Not yet recruiting
Lenox Hill Cystic Fibrosis Center	New York	New York	10028	Recruiting
Columbia University Cystic Fibrosis Program	New York	New York	10032	Not yet recruiting
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	27514	Not yet recruiting
University of Pennsylvania	Philadelphia	Pennsylvania	19104	Not yet recruiting
University of Utah	Salt Lake City	Utah	84132	Not yet recruiting
Inova Fairfax Hospital	Falls Church	Virginia	22042	Not yet recruiting
University of Washington Medical Center	Seattle	Washington	98195	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06429176, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 10, 2026 · Synced Nov 15, 2026