NCT07035990

Safety, Tolerability, and Pharmacokinetics of Multiple Dose Combinations of SION-451 and Complementary Modulators SION-2222 and SION-109 in Healthy Participants.

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: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Sionna Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of Parts D and E of this Phase 1 study are to evaluate the safety, tolerability, and pharmacokinetics of multiple dose combinations of SION-451 and complementary modulators SION-2222 and SION-109 in healthy participants.

Detailed description

This is a Phase 1 randomized, double-blind, placebo-controlled study. Parts D and E will evaluate the safety, tolerability, and pharmacokinetics of multiple dose combinations of SION-451 and complementary modulators SION-2222 and SION-109 in healthy participants. Parts A, B, and C of this study have completed dosing. Part D will involve multiple dosing of SION-451 and SION-2222 in combination. Part E will involve multiple dosing of SION-451 and SION-109 in combination.

Conditions

• Cystic Fibrosis (CF)

Interventions

Type	Name	Description
DRUG	SION-451	* Pharmaceutical form: tablet * Route of administration: oral
DRUG	SION-2222	* Pharmaceutical form: capsule * Route of administration: oral
DRUG	SION-109	* Pharmaceutical form: tablet * Route of administration: oral
DRUG	Placebo SION-451	Placebo matched to SION-451
DRUG	Placebo SION-2222	Placebo matched to SION-2222
DRUG	Placebo SION-109	Placebo matched to SION-109

Timeline

• Start date: 2025-07-23
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-06-25
• Last updated: 2025-09-03

Locations

2 sites across 1 country: Australia