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Completed

NCT Number: NCT07272629

A Study to Evaluate the Effect of Single Oral 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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit- Site Number : 8400002, Dallas, Texas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

balinatunfib

Drug

Pharmaceutical form: Tablet Route of administration: Oral

Other names: SAR441566

moxifloxacin

Drug

Pharmaceutical form: Tablet Route of administration: Oral

Placebo

Drug

Pharmaceutical form: Tablet Route of administration: Oral

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from baseline in heart rate (HR)

    Time frame: Day 1 to Day 2

  2. Change from baseline in QT interval

    Time frame: Baseline to day 2 of each period

  3. Change from baseline in QT interval corrected using the Bazett formula (QTcB)

    Time frame: Baseline to day 2 of each period

  4. Change from baseline in population specific QT correction (QTcN) interval

    Time frame: Baseline to day 2 of each period

  5. Change from baseline in QRS interval

    Time frame: Baseline to day 2 of each period

  6. Change from baseline in PR interval

    Time frame: Baseline to day 2 of each period

  7. Safety for electrocardiogram (ECG) parameters

    Time frame: Baseline to day 83

  8. Maximum plasma concentration (Cmax) for balinatunfib

    Time frame: Baseline to day 6 of each period

  9. Time to reach the maximum concentration (tmax) for balinatunfib

    Time frame: Baseline to day 6 of each period

  10. Area under the curve (AUC) for balinatunfib

    Time frame: Baseline to day 6 of each period

  11. Maximum plasma concentration (Cmax) for balinatunfib metabolite M8

    Time frame: Baseline to day 6 of each period

  12. Time to reach the maximum concentration (tmax) for balinatunfib metabolite M8

    Time frame: Baseline to day 6 of each period

  13. Area under the curve (AUC) for balinatunfib metabolite M8

    Time frame: Baseline to day 6 of each period

  14. 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

  15. Number of participants with clinical laboratory and vital signs abnormalities (potentially clinically significant abnormality)

    Time frame: Baseline to Day 83

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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