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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.
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
Conditions
Interventions
SION-451
* Pharmaceutical form: tablet * Route of administration: oral
SION-2222
* Pharmaceutical form: capsule * Route of administration: oral
SION-109
* Pharmaceutical form: tablet * Route of administration: oral
Placebo SION-451
Placebo matched to SION-451
Placebo SION-2222
Placebo matched to SION-2222
Placebo SION-109
Placebo matched to SION-109
Locations (2)
Nucleus Network
Brisbane, Queensland, Australia
Nucleus Network
Melbourne, Victoria, Australia