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Heart safety check for new drug balinatunfib
NCT ID NCT07272629
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 Hide 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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