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

NCT07272629 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: TES18591U1111-1316-0289
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cardiac Repolarization; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

Study Arms (4)

Balinatunfib Treatment A

EXPERIMENTAL

Participants will receive a single oral dose of balinatunfib.

Drug: Balinatunfib; Drug: Placebo

Balinatunfib Treatment B

EXPERIMENTAL

Participants will receive a single oral dose of balinatunfib.

Drug: Balinatunfib; Drug: Placebo

Moxifloxacin Treatment C

ACTIVE COMPARATOR

Participants will receive a single oral dose of moxifloxacin.

Drug: Moxifloxacin; Drug: Placebo

Placebo Treatment D

PLACEBO COMPARATOR

Participants will receive a single oral dose of balinatunfib matching placebo and moxifloxacin matching placebo.

Drug: Placebo

Interventions

Balinatunfib DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Also known as: SAR441566

Balinatunfib Treatment A; Balinatunfib Treatment B

Moxifloxacin DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Moxifloxacin Treatment C

Placebo DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Balinatunfib Treatment A; Balinatunfib Treatment B; Moxifloxacin Treatment C; Placebo Treatment D

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Both males and females aged 18-55 years are eligible, with at least 30% representation from each gender.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

FORTREA CLINICAL RESEARCH UNIT INC- Site Number : 8400002

Dallas, Texas, 75247, United States

RECRUITING

FORTREA CLINICAL RESEARCH UNIT INC- Site Number : 8400001

Madison, Wisconsin, 53704, United States

RECRUITING

Related Links

• TES18591 Plain Language Results Summary

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Williams design

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: December 4, 2025
• Primary Completion: April 27, 2026
• Study Completion: April 27, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (2)