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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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 17 Dec 2024

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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

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