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Heart safety check for new drug balinatunfib

NCT ID NCT07272629

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 study tested whether a single dose of balinatunfib affects the heart's electrical activity in 48 healthy adults aged 18 to 55. Participants received balinatunfib, a placebo, and an active control (moxifloxacin) in a crossover design. The main goal was to measure changes in the QT interval, a key heart rhythm safety marker.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
balinatunfib (also known as SAR441566)
What this could lead to
If successful, this study could show that balinatunfib is safe for the heart, supporting further development as a treatment.
What could go wrong
This is an early Phase 1 safety study in healthy volunteers, not patients. It only looks at heart rhythm effects and does not test if the drug works for any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

48 people

The number who actually took part.

Started

Dec 2025

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Fortrea Clinical Research Unit- Site Number : 8400002

    Dallas, Texas, 75247, United States

  • Labcorp Clinical Research- Site Number : 8400001

    Madison, Wisconsin, 53704, United States

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