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
Latest Information Update: 17 Dec 2024
At a glance
- Drugs SPL 84 (Primary)
- Indications Cystic fibrosis
- Focus Proof of concept; Therapeutic Use
- Sponsors SpliSense
Most Recent Events
- 29 May 2024 According to a SpliSense media release, recent IND clearance received from the FDA together with this Fast Track designation for SPL84, currently being evaluated in this global Phase 2 study, will allow to expedite the development of a potentially life-changing treatment for people with CF carrying the 3849+10 Kb C->T mutation.
- 20 May 2024 Status changed to recruiting.
- 05 Apr 2024 New trial record