Actively Recruiting
Safety, Tolerability, and Pharmacokinetics of Multiple Dose Combinations of SION-451 and Complementary Modulators SION-2222 and SION-109 in Healthy Participants.
Led by Sionna Therapeutics Inc. · Updated on 2025-09-03
144
Participants Needed
2
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety, Tolerability, and Pharmacokinetics of Multiple Dose Combinations of SION-451 and Complementary Modulators SION-2222 and SION-109 in Healthy Participants.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female adults aged 18 to 55 years
- Weight at least 45 kg with body mass index between 18.0 and 32.0
- Willingness to abstain from alcohol, caffeine, smoking, nicotine products for 72 hours before Day -1 and during study
- Willingness to avoid cruciferous vegetables, charcoal-grilled meats, and poppy seeds for 48 hours before dosing and during study
- Ability and willingness to comply with study procedures and restrictions
- Provided written informed consent
You will not qualify if you...
- Clinically significant current or recurrent illnesses affecting safety or lab evaluations
- History of cancer except basal or squamous skin carcinomas resected with no recurrence for at least 1 year
- Significant abnormalities on ECG, physical exam, or vital signs at screening or Day -1
- Any QTcF reading >470 ms (females) or >450 ms (males) at screening or Day -1
- Chronic or habitual alcohol use (>10 drinks/week), tobacco use (>10 cigarettes/week), or recreational drug use (>1 use/month) unless excluded by investigator discretion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Nucleus Network
Brisbane, Queensland, Australia, 4006
Actively Recruiting
2
Nucleus Network
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
C
Cecile LeCamus
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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