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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.

NCT07035990 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-09-03

No results posted yet for this study

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.

Conditions

  • Cystic Fibrosis (CF)

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

Sponsors & Collaborators

  • Sionna Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Philip Ryan, MBBS, BMedSc, PhD, DPM, FFPM · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-23
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07035990 on ClinicalTrials.gov