RecruitingPhase 1NCT07035990

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.


Sponsor

Sionna Therapeutics Inc.

Enrollment

144 participants

Start Date

Jul 23, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo SION-109, a drug called Placebo SION-2222, and others for people with cystic fibrosis (cf). The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSION-451

* Pharmaceutical form: tablet * Route of administration: oral

DRUGSION-2222

* Pharmaceutical form: capsule * Route of administration: oral

DRUGSION-109

* Pharmaceutical form: tablet * Route of administration: oral

DRUGPlacebo SION-451

Placebo matched to SION-451

DRUGPlacebo SION-2222

Placebo matched to SION-2222

DRUGPlacebo SION-109

Placebo matched to SION-109


Locations(2)

Nucleus Network

Brisbane, Queensland, Australia

Nucleus Network

Melbourne, Victoria, Australia

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NCT07035990


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