Cardiac RepolarizationPhase 1NCT07272629
A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.
A Phase 1 study testing Balinatunfib and Moxifloxacin in people with Cardiac Repolarization and Healthy Volunteers, run by Sanofi at 2 sites in United States.
Trial summary
This is a Phase 1, multicenter, randomized, double-blind, double-dummy, single dose, placebo- and positive-controlled, 4-sequence, 4-treatment, 4-period crossover study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Repolarization, Healthy Volunteers
- What is being tested?
- Balinatunfib and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Dec 2025to 8 Jun 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
- Age: Healthy males and/or females aged 18 to 55 (inclusive) at consent signing.
- Certified healthy based on history, physical exam, vitals, ECG, and labs with no abnormalities.
- Weight: 50-100 kg (male), 40-90 kg (female); BMI 18-30 kg/m² inclusive.
- Sex-based eligibility: All males must use effective contraception or remain abstinent and avoid sperm donation for 3 months post-dose. Females must use highly effective contraception, not be pregnant or breastfeeding, and test negative for pregnancy before treatment.
Who cannot join
- History of significant systemic diseases (hematologic, renal, endocrine, pulmonary, GI, cardiac, hepatic, psychiatric, neurologic, infectious, allergic; except mild seasonal allergies).
- Clinically significant ECG abnormalities.
- Frequent headaches or migraines, and recurrent nausea or vomiting (over twice monthly).
- Blood donation within 2 months.
- Symptomatic or significant postural hypotension.
- Drug hypersensitivity or significant allergies, including to study drugs.
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- History of drug/alcohol abuse.
- Tobacco use within 3 months prior to Day 1.
- History of Hepatitis B/C, TB, or invasive opportunistic infections.
- Malignancy within 5 years (except treated non-metastatic skin cancer).
- Adverse reaction to balinatunfib, moxifloxacin, or quinolones.
- Any medication (except hormonal contraception/HRT) within 14 days or 5× half-life.
- Biologics within 4 months prior.
- Vaccines: non-live within 4 weeks, live within 3 months before or during study.
- Current or recent participation in another interventional study within 30 days.
- Positive for HBsAg, anti-HBc, anti-HCV, anti-HIV1/2.
- Positive urine drug screen.
- Positive alcohol breath test.
- Positive urine cotinine test.
- History of long QT syndrome.
- Risk factors for TdP.
- Moxifloxacin contraindications.
- Low potassium (<3.5 mmol/L).
- Low magnesium (<0.7 mmol/L).
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fortrea Clinical Research Unit- Site Number : 8400002
Dallas, Texas, 75247
Labcorp Clinical Research- Site Number : 8400001
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Multicenter, Randomized, Double-blind, Double-dummy, Placebo- and Positive-controlled, 4-period Crossover Study to Evaluate the Effect of a Single Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.
This is a Phase 1, multicenter, randomized, double-blind, double-dummy, single dose, placebo- and positive-controlled, 4-sequence, 4-treatment, 4-period crossover study.
- Conditions
- Cardiac Repolarization, Healthy Volunteers
- Being tested
- Balinatunfib, Moxifloxacin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BalinatunfibDrug
Also called SAR441566
Pharmaceutical form: Tablet Route of administration: Oral
MoxifloxacinDrug
Pharmaceutical form: Tablet Route of administration: Oral
PlaceboDrug
Pharmaceutical form: Tablet Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Balinatunfib Treatment A | Experimental | Participants will receive a single oral dose of balinatunfib. Receives: Drug: Balinatunfib; Drug: Placebo |
| Balinatunfib Treatment B | Experimental | Participants will receive a single oral dose of balinatunfib. Receives: Drug: Balinatunfib; Drug: Placebo |
| Moxifloxacin Treatment C | Active comparator | Participants will receive a single oral dose of moxifloxacin. Receives: Drug: Moxifloxacin; Drug: Placebo |
| Placebo Treatment D | Placebo comparator | Participants will receive a single oral dose of balinatunfib matching placebo and moxifloxacin matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the QT interval corrected using the Fridericia formula (QTcF) centrally assessed using a semi-automatic reading
Measured: Baseline to day 2
Secondary outcomes (15)
Change from baseline in heart rate (HR)
Measured: Day 1 to Day 2
Change from baseline in QT interval
Measured: Baseline to day 2 of each period
Change from baseline in QT interval corrected using the Bazett formula (QTcB)
Measured: Baseline to day 2 of each period
Change from baseline in population specific QT correction (QTcN) interval
Measured: Baseline to day 2 of each period
Change from baseline in QRS interval
Measured: Baseline to day 2 of each period
Change from baseline in PR interval
Measured: Baseline to day 2 of each period
Safety for electrocardiogram (ECG) parameters
Measured: Baseline to day 83
Maximum plasma concentration (Cmax) for balinatunfib
Measured: Baseline to day 6 of each period
Time to reach the maximum concentration (tmax) for balinatunfib
Measured: Baseline to day 6 of each period
Area under the curve (AUC) for balinatunfib
Measured: Baseline to day 6 of each period
Maximum plasma concentration (Cmax) for balinatunfib metabolite M8
Measured: Baseline to day 6 of each period
Time to reach the maximum concentration (tmax) for balinatunfib metabolite M8
Measured: Baseline to day 6 of each period
Area under the curve (AUC) for balinatunfib metabolite M8
Measured: Baseline to day 6 of each period
Number of participants experiencing treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESIs) and serious adverse events (SAEs)
Measured: Baseline to Day 83
Number of participants with clinical laboratory and vital signs abnormalities (potentially clinically significant abnormality)
Measured: Baseline to Day 83
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start4 Dec 2025
- Primary completion28 May 2026
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RepolarizationStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Williams design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272629
- Sponsor's protocol ID
- TES18591
- Other IDs
- U1111-1316-0289
- Status last verified
- Jun 2026
- First submitted
- 26 Nov 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Randomized, Double-blind, Double-dummy, Placebo- and Positive-controlled, 4-period Crossover Study to Evaluate the Effect of a Single Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.
- ClinicalTrials.gov ID
- NCT07272629
- Acronym / sponsor ID
- TES18591
- Conditions
- Cardiac Repolarization, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 9 Dec 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.
This is a Phase 1, multicenter, randomized, double-blind, double-dummy, single dose, placebo- and positive-controlled, 4-sequence, 4-treatment, 4-period crossover study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Williams design
| Arm | Type | Receives |
|---|---|---|
| Balinatunfib Treatment A | Experimental | Drug: Balinatunfib, Drug: PlaceboParticipants will receive a single oral dose of balinatunfib. |
| Balinatunfib Treatment B | Experimental | Drug: Balinatunfib, Drug: PlaceboParticipants will receive a single oral dose of balinatunfib. |
| Moxifloxacin Treatment C | Active comparator | Drug: Moxifloxacin, Drug: PlaceboParticipants will receive a single oral dose of moxifloxacin. |
| Placebo Treatment D | Placebo comparator | Drug: PlaceboParticipants will receive a single oral dose of balinatunfib matching placebo and moxifloxacin matching placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: Healthy males and/or females aged 18 to 55 (inclusive) at consent signing.
- Certified healthy based on history, physical exam, vitals, ECG, and labs with no abnormalities.
- Weight: 50-100 kg (male), 40-90 kg (female); BMI 18-30 kg/m² inclusive.
- Sex-based eligibility: All males must use effective contraception or remain abstinent and avoid sperm donation for 3 months post-dose. Females must use highly effective contraception, not be pregnant or breastfeeding, and test negative for pregnancy before treatment.
Key exclusion criteria (25 listed)
- History of significant systemic diseases (hematologic, renal, endocrine, pulmonary, GI, cardiac, hepatic, psychiatric, neurologic, infectious, allergic; except mild seasonal allergies).
- Clinically significant ECG abnormalities.
- Frequent headaches or migraines, and recurrent nausea or vomiting (over twice monthly).
- Blood donation within 2 months.
- Symptomatic or significant postural hypotension.
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 |
|---|---|---|
| BalinatunfibAlso: SAR441566Pharmaceutical form: Tablet Route of administration: Oral | Drug | Balinatunfib Treatment A, Balinatunfib Treatment B |
| MoxifloxacinPharmaceutical form: Tablet Route of administration: Oral | Drug | Moxifloxacin Treatment C |
| PlaceboPharmaceutical form: Tablet Route of administration: Oral | Drug | Balinatunfib Treatment A, Balinatunfib Treatment B, Moxifloxacin Treatment C, Placebo Treatment D |
Primary outcome
Change from baseline in the QT interval corrected using the Fridericia formula (QTcF) centrally assessed using a semi-automatic reading
Time frame: Baseline to day 2
15 secondary outcomes
Change from baseline in heart rate (HR)
Time frame: Day 1 to Day 2
Change from baseline in QT interval
Time frame: Baseline to day 2 of each period
Change from baseline in QT interval corrected using the Bazett formula (QTcB)
Time frame: Baseline to day 2 of each period
Change from baseline in population specific QT correction (QTcN) interval
Time frame: Baseline to day 2 of each period
Change from baseline in QRS interval
Time frame: Baseline to day 2 of each period
Change from baseline in PR interval
Time frame: Baseline to day 2 of each period
Safety for electrocardiogram (ECG) parameters
Time frame: Baseline to day 83
Maximum plasma concentration (Cmax) for balinatunfib
Time frame: Baseline to day 6 of each period
Time to reach the maximum concentration (tmax) for balinatunfib
Time frame: Baseline to day 6 of each period
Area under the curve (AUC) for balinatunfib
Time frame: Baseline to day 6 of each period
Maximum plasma concentration (Cmax) for balinatunfib metabolite M8
Time frame: Baseline to day 6 of each period
Time to reach the maximum concentration (tmax) for balinatunfib metabolite M8
Time frame: Baseline to day 6 of each period
Area under the curve (AUC) for balinatunfib metabolite M8
Time frame: Baseline to day 6 of each period
Number of participants experiencing treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESIs) and serious adverse events (SAEs)
Time frame: Baseline to Day 83
Number of participants with clinical laboratory and vital signs abnormalities (potentially clinically significant abnormality)
Time frame: Baseline to Day 83
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 23 Jun 2026.
- TES18591 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Balinatunfib and Moxifloxacin in people with Cardiac Repolarization and Healthy Volunteers, run by Sanofi at 2 sites in United States.
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 4 inclusion and 25 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 23 Jun 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 United States. 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?
Change from baseline in the QT interval corrected using the Fridericia formula (QTcF) centrally assessed using a semi-automatic reading (time frame: Baseline to day 2). 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 23 Jun 2026.