Cystic Fibrosis (CF)Phase 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 study testing SION-451, SION-2222 and SION-109 in people with Cystic Fibrosis (CF), run by Sionna Therapeutics Inc. at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis (CF)
- What is being tested?
- SION-451, SION-2222 and SION-109
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesAustralia
- Study dates
- 23 Jul 2025to 23 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Nucleus Network
Brisbane, Queensland, 4006
Nucleus Network
Melbourne, Victoria, 3004
About this study
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.
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.
Read the 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.
- Conditions
- Cystic Fibrosis (CF)
- Being tested
- SION-451, SION-2222, SION-109, Placebo SION-451, Placebo SION-2222
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SION-451Drug
- Pharmaceutical form: tablet
- Route of administration: oral
SION-2222Drug
- Pharmaceutical form: capsule
- Route of administration: oral
SION-109Drug
- Pharmaceutical form: tablet
- Route of administration: oral
Placebo SION-451Drug
Placebo matched to SION-451
Placebo SION-2222Drug
Placebo matched to SION-2222
Placebo SION-109Drug
Placebo matched to SION-109
| Study group | Role | What they receive |
|---|---|---|
| SION-451 + SION-2222 | Experimental | All participants who receive SION-451 in combination with SION-2222 Receives: Drug: SION-451; Drug: SION-2222 |
| Placebo matched to SION-451 and SION-2222 | Placebo comparator | Not described Receives: Drug: Placebo SION-451; Drug: Placebo SION-2222 |
| SION 451 + SION 109 | Experimental | All participants who receive SION-451 in combination with SION-109 Receives: Drug: SION-451; Drug: SION-109 |
| Placebo matched to SION-451 and SION-109 | Placebo comparator | Not described Receives: Drug: Placebo SION-451; Drug: Placebo SION-109 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Adverse reactions to the study drug combination SION-451 and SION-109 will be measured.
Measured: 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
Adverse events to the study drug combination SION-451 and SION-2222 will be measured
Measured: From Day 1 through day 21
Secondary outcomes (12)
Cmax of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
Measured: From Day 1 through day 17
Tmax of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
Measured: From Day 1 through day 17
AUC of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
Measured: From Day 1 through day 17
t1/2 of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
Measured: From Day 1 through day 17
Volume of distribution of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
Measured: From Day 1 through day 17
Apparent total clearance of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
Measured: From Day 1 through day 17
Cmax of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Measured: From Day 1 through day 17
Tmax of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Measured: From Day 1 through day 17
AUC of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Measured: From Day 1 through day 17
t1/2 of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Measured: From Day 1 through day 17
Volume of distribution of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Measured: From Day 1 through day 17
Apparent total clearance of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Measured: From Day 1 through day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start23 Jul 2025
- Primary completion23 Mar 2026
- Study completion23 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sionna Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Ryan, MBBS, BMedSc, PhD, DPM, FFPM, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035990
- Sponsor's protocol ID
- SION-451-101
- Other IDs
- ACTRN12624000849895, ACTRN12624000848505
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07035990
- Acronym / sponsor ID
- SION-451-101
- Conditions
- Cystic Fibrosis (CF)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sionna Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SION-451 + SION-2222 | Experimental | Drug: SION-451, Drug: SION-2222All participants who receive SION-451 in combination with SION-2222 |
| Placebo matched to SION-451 and SION-2222 | Placebo comparator | Drug: Placebo SION-451, Drug: Placebo SION-2222 |
| SION 451 + SION 109 | Experimental | Drug: SION-451, Drug: SION-109All participants who receive SION-451 in combination with SION-109 |
| Placebo matched to SION-451 and SION-109 | Placebo comparator | Drug: Placebo SION-451, Drug: Placebo SION-109 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SION-451* Pharmaceutical form: tablet * Route of administration: oral | Drug | SION 451 + SION 109, SION-451 + SION-2222 |
| SION-2222* Pharmaceutical form: capsule * Route of administration: oral | Drug | SION-451 + SION-2222 |
| SION-109* Pharmaceutical form: tablet * Route of administration: oral | Drug | SION 451 + SION 109 |
| Placebo SION-451Placebo matched to SION-451 | Drug | Placebo matched to SION-451 and SION-109, Placebo matched to SION-451 and SION-2222 |
| Placebo SION-2222Placebo matched to SION-2222 | Drug | Placebo matched to SION-451 and SION-2222 |
| Placebo SION-109Placebo matched to SION-109 | Drug | Placebo matched to SION-451 and SION-109 |
Primary outcome
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
Adverse reactions to the study drug combination SION-451 and SION-109 will be measured.
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
Adverse events to the study drug combination SION-451 and SION-2222 will be measured
12 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Ryan, MBBS, BMedSc, PhD, DPM, FFPM principal investigator
Nucleus Network
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SION-451, SION-2222 and SION-109 in people with Cystic Fibrosis (CF), run by Sionna Therapeutics Inc. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.