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RECRUITING
NCT07035990
PHASE1

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

Sponsor: Sionna Therapeutics Inc.

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2025-07-23

Completion Date

2026-06

Last Updated

2025-09-03

Healthy Volunteers

Yes

Interventions

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

Locations (2)

Nucleus Network

Brisbane, Queensland, Australia

Nucleus Network

Melbourne, Victoria, Australia