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A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of SION-451, and Multiple Dose Combinations of SION-451 and Complementary Modulators SION-2222 and SION-109 in Healthy Participants.

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Trial Profile

A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of SION-451, and Multiple Dose Combinations of SION-451 and Complementary Modulators SION-2222 and SION-109 in Healthy Participants.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 15 Sep 2026

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At a glance

  • Drugs Galicaftor (Primary) ; SION 109 (Primary) ; SION 451 (Primary)
  • Indications Cystic fibrosis
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors Sionna Therapeutics

Most Recent Events

  • 10 Sep 2026 Status changed from recruiting to completed.
  • 10 Aug 2026 According to a Sionna Therapeutics media release, Two participants discontinued due to elevated liver function tests and flu-like symptoms.
  • 10 Aug 2026 Topline results presented at Sionna Therapeutics, Inc. media release.

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