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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07035990




Registration number
NCT07035990
Ethics application status
Date submitted
4/06/2025
Date registered
25/06/2025
Date last updated
25/06/2025

Titles & IDs
Public title
Safety, Tolerability, and Pharmacokinetics of Multiple Dose Combinations of SION-451 and Complementary Modulators SION-2222 and SION-109 in Healthy Participants.
Scientific 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.
Secondary ID [1] 0 0
ACTRN12624000849895
Secondary ID [2] 0 0
SION-451-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis (CF) 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SION-451
Treatment: Drugs - SION-2222
Treatment: Drugs - SION-109
Treatment: Drugs - Placebo SION-451
Treatment: Drugs - Placebo SION-2222
Treatment: Drugs - Placebo SION-109

Experimental: SION-451 + SION-2222 - All participants who receive SION-451 in combination with SION-2222

Placebo comparator: Placebo matched to SION-451 and SION-2222 -

Experimental: SION 451 + SION 109 - All participants who receive SION-451 in combination with SION-109

Placebo comparator: Placebo matched to SION-451 and SION-109 -


Treatment: Drugs: SION-451
* Pharmaceutical form: tablet
* Route of administration: oral

Treatment: Drugs: SION-2222
* Pharmaceutical form: capsule
* Route of administration: oral

Treatment: Drugs: SION-109
* Pharmaceutical form: tablet
* Route of administration: oral

Treatment: Drugs: Placebo SION-451
Placebo matched to SION-451

Treatment: Drugs: Placebo SION-2222
Placebo matched to SION-2222

Treatment: Drugs: Placebo SION-109
Placebo matched to SION-109
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From Day 1 through day 21
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
From Day 1 through day 21
Secondary outcome [1] 0 0
Cmax of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
Timepoint [1] 0 0
From Day 1 through day 17
Secondary outcome [2] 0 0
Tmax of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
Timepoint [2] 0 0
From Day 1 through day 17
Secondary outcome [3] 0 0
AUC of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
Timepoint [3] 0 0
From Day 1 through day 17
Secondary outcome [4] 0 0
t1/2 of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
Timepoint [4] 0 0
From Day 1 through day 17
Secondary outcome [5] 0 0
Volume of distribution of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
Timepoint [5] 0 0
From Day 1 through day 17
Secondary outcome [6] 0 0
Apparent total clearance of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
Timepoint [6] 0 0
From Day 1 through day 17
Secondary outcome [7] 0 0
Cmax of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Timepoint [7] 0 0
From Day 1 through day 17
Secondary outcome [8] 0 0
Tmax of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Timepoint [8] 0 0
From Day 1 through day 17
Secondary outcome [9] 0 0
AUC of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Timepoint [9] 0 0
From Day 1 through day 17
Secondary outcome [10] 0 0
t1/2 of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Timepoint [10] 0 0
From Day 1 through day 17
Secondary outcome [11] 0 0
Volume of distribution of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Timepoint [11] 0 0
From Day 1 through day 17
Secondary outcome [12] 0 0
Apparent total clearance of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Timepoint [12] 0 0
From Day 1 through day 17

Eligibility
Key inclusion criteria
1. Healthy male or female adult participants aged 18 to 55 years, inclusive, at the time of consent.
2. Weight of at least 45 kg and body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
3. 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.
4. Participant has read, understood, and voluntarily provided written informed consent
5. Participant has an understanding, ability, and willingness to fully comply with study procedures and restrictions.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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.
2. 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.
3. Participant has clinically significant abnormalities, in the opinion of the investigator, on ECG, physical examination, or vital sign assessment at Screening or Day -1.
4. Participant has any single reading of QTcF >470 ms (females) or >450 ms (males) at Screening or Day -1.
5. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
144
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Nucleus Network - Brisbane
Recruitment hospital [2] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
4006 - Brisbane
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sionna Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philip Ryan, MBBS, BMedSc, PhD, DPM, FFPM
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Arun K Senapati, MS, MBA
Address 0 0
Country 0 0
Phone 0 0
817-715-1020
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07035990