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

Part of paid clinical trials in Los Angeles, California.

Sponsor
SpliSense Ltd.
Study ID
NCT06429176
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SPL84 — DRUG
    SPL84 solution for nebulization
  • Placebo — OTHER
    Placebo solution for nebulization

Study Details

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.

Key Dates

Start date
Jun 24, 2024
Status verified
May 2026
Primary completion
Oct 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: SPL84
  • Placebo Comparator: Placebo

Primary Outcome Measure

Safety and Tolerability of SPL84 as evaluated by number of subjects with at least one treatment-related adverse event (AE) or serious adverse event (SAEs) [ Time Frame: Day 1 through Day 87 (Cohort 1-3) or 108 (Cohort 4) ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033
Study Coordinator
[email protected]
+1 323 409 5383
National Jewish HealthDenverColorado80206
Site Manager
[email protected]
303-270-2517
Boston Children'S HospitalBostonMassachusetts02115
Julia Giancola
[email protected]
617-355-4171

Find similar trials in Los Angeles, CA

By research site
University of Southern California· Los Angeles, CANational Jewish Health· Denver, COBoston Children'S Hospital· Boston, MA

Related Studies