Safety, Tolerability, and Pharmacokinetics of Multiple Dose Combinations of SION-451 and Complementary Modulators SION-2222 and SION-109 in Healthy Participants.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SION-451, SION-2222, SION-109, Placebo SION-451.
- Who it may be relevant to
- Registry conditions: Cystic Fibrosis (CF). Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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.
Detailed description
This is a Phase 1 randomized, double-blind, placebo-controlled study. Parts D and E will evaluate the safety, tolerability, and pharmacokinetics of multiple dose combinations of SION-451 and complementary modulators SION-2222 and SION-109 in healthy participants. Parts A, B, and C of this study have completed dosing.
Part D will involve multiple dosing of SION-451 and SION-2222 in combination. Part E will involve multiple dosing of SION-451 and SION-109 in combination.
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
Primary outcome measures
- To evaluate the incidence of treatment emergent adverse events [Safety and Tolerability] of SION-451 and SION-109 when administered in combination to healthy participants [Time frame: From Day 1 through day 21]
- To evaluate the incidence of treatment emergent adverse events [Safety and Tolerability] of SION-451 and SION-2222 when administered in combination to healthy participants [Time frame: From Day 1 through day 21]
Secondary outcome measures (12)
- Cmax of SION-451 and SION-2222 in plasma when administered in combination to healthy participants [Time frame: From Day 1 through day 17]
- Tmax of SION-451 and SION-2222 in plasma when administered in combination to healthy participants [Time frame: From Day 1 through day 17]
- AUC of SION-451 and SION-2222 in plasma when administered in combination to healthy participants [Time frame: From Day 1 through day 17]
- t1/2 of SION-451 and SION-2222 in plasma when administered in combination to healthy participants [Time frame: From Day 1 through day 17]
- Volume of distribution of SION-451 and SION-2222 in plasma when administered in combination to healthy participants [Time frame: From Day 1 through day 17]
- Apparent total clearance of SION-451 and SION-2222 in plasma when administered in combination to healthy participants [Time frame: From Day 1 through day 17]
- Cmax of SION-451 and SION-109 in plasma when administered in combination to healthy participants [Time frame: From Day 1 through day 17]
- Tmax of SION-451 and SION-109 in plasma when administered in combination to healthy participants [Time frame: From Day 1 through day 17]
- AUC of SION-451 and SION-109 in plasma when administered in combination to healthy participants [Time frame: From Day 1 through day 17]
- t1/2 of SION-451 and SION-109 in plasma when administered in combination to healthy participants [Time frame: From Day 1 through day 17]
- Volume of distribution of SION-451 and SION-109 in plasma when administered in combination to healthy participants [Time frame: From Day 1 through day 17]
- Apparent total clearance of SION-451 and SION-109 in plasma when administered in combination to healthy participants [Time frame: From Day 1 through day 17]
Eligibility criteria
Inclusion criteria
- Healthy male or female adult participants aged 18 to 55 years, inclusive, at the time of consent.
- Weight of at least 45 kg and body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
- Participant is willing to abstain from alcohol, caffeine, smoking and nicotine-containing products for 72 hours prior to Day -1 through the duration of the study. Participant is willing to abstain from eating cruciferous vegetables, charcoal-grilled meats, and poppy seeds for 48 hours prior to dosing throughout the duration of the study.
- Participant has read, understood, and voluntarily provided written informed consent
- Participant has an understanding, ability, and willingness to fully comply with study procedures and restrictions.
Exclusion criteria
- Participant has clinically significant, in the opinion of the investigator, current or recurrent illness, such as cardiovascular (including but not limited to known structural cardiac abnormalities, family history of long QT syndrome, or cardiac syncope or recurrent, idiopathic syncope), neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine, or psychiatric disease or disorder, or other abnormality which may affect safety or clinical laboratory evaluations.
- Participant has a history of malignancy, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of recurrence for at least 1 year.
- Participant has clinically significant abnormalities, in the opinion of the investigator, on ECG, physical examination, or vital sign assessment at Screening or Day -1.
- Participant has any single reading of QTcF >470 ms (females) or >450 ms (males) at Screening or Day -1.
- Chronic or habitual alcohol (>10 standard drinks per week) or tobacco (>10 cigarettes per week) use or use of recreational drugs (>1 use per month). The Investigator may exclude a participant with lower levels of alcohol, tobacco, or recreational drug use based on discretion and the pattern or history of use.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Australia · 2 centers
- Nucleus Network — Brisbane
- Nucleus Network — Melbourne
Identifiers
NCT: NCT07035990 · SION-451-101 · ACTRN12624000849895 · ACTRN12624000848505