A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Volunteers; Cardiac Repolarization
• Intervention / Treatment: Drug: Placebo; Drug: Balinatunfib; Drug: Moxifloxacin

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Fortrea Clinical Research Unit- Site Number : 8400002
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Labcorp Clinical Research- Site Number : 8400001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balinatunfib Treatment A; Participants will receive a single oral dose of balinatunfib.	Drug: Placebo; Pharmaceutical form: Tablet Route of administration: Oral; Drug: Balinatunfib; Pharmaceutical form: Tablet Route of administration: Oral; Other Names: SAR441566
Experimental: Balinatunfib Treatment B; Participants will receive a single oral dose of balinatunfib.	Drug: Placebo; Pharmaceutical form: Tablet Route of administration: Oral; Drug: Balinatunfib; Pharmaceutical form: Tablet Route of administration: Oral; Other Names: SAR441566
Active Comparator: Moxifloxacin Treatment C; Participants will receive a single oral dose of moxifloxacin.	Drug: Placebo; Pharmaceutical form: Tablet Route of administration: Oral; Drug: Moxifloxacin; Pharmaceutical form: Tablet Route of administration: Oral
Placebo Comparator: Placebo Treatment D; Participants will receive a single oral dose of balinatunfib matching placebo and moxifloxacin matching placebo.	Drug: Placebo; Pharmaceutical form: Tablet Route of administration: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the QT interval corrected using the Fridericia formula (QTcF) centrally assessed using a semi-automatic reading	Baseline to day 2

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in heart rate (HR)	Day 1 to Day 2
Change from baseline in QT interval	Baseline to day 2 of each period
Change from baseline in QT interval corrected using the Bazett formula (QTcB)	Baseline to day 2 of each period
Change from baseline in population specific QT correction (QTcN) interval	Baseline to day 2 of each period
Change from baseline in QRS interval	Baseline to day 2 of each period
Change from baseline in PR interval	Baseline to day 2 of each period
Safety for electrocardiogram (ECG) parameters	Baseline to day 83
Maximum plasma concentration (Cmax) for balinatunfib	Baseline to day 6 of each period
Time to reach the maximum concentration (tmax) for balinatunfib	Baseline to day 6 of each period
Area under the curve (AUC) for balinatunfib	Baseline to day 6 of each period
Maximum plasma concentration (Cmax) for balinatunfib metabolite M8	Baseline to day 6 of each period
Time to reach the maximum concentration (tmax) for balinatunfib metabolite M8	Baseline to day 6 of each period
Area under the curve (AUC) for balinatunfib metabolite M8	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)	Baseline to Day 83
Number of participants with clinical laboratory and vital signs abnormalities (potentially clinically significant abnormality)	Baseline to Day 83

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

Helpful Links

• TES18591 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2025
• Primary Completion (Actual): May 28, 2026
• Study Completion (Estimated): June 8, 2026

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 9, 2025

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Moxifloxacin
• Other Study ID Numbers: TES18591; U1111-1316-0289 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No