Single oral dose of balinatunfib and its effect on heart electrical recovery in healthy adults

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 study will test whether a single oral dose of balinatunfib changes the heart's electrical recovery (cardiac repolarization) in healthy adults aged 18 to 55.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Sanofi (Industry-sponsored)
• Locations: 2 sites (Dallas, Texas and 1 other locations)
• Trial ID: NCT07272629 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, multicenter, randomized, double-blind, double-dummy, single-dose, placebo- and positive-controlled, 4-sequence, 4-period crossover trial in healthy volunteers. Participants will receive single doses of balinatunfib, moxifloxacin (positive control), and placebo across different periods with washouts between treatments. Serial ECGs and safety labs will be collected to measure effects on cardiac repolarization (including QT interval) and to monitor adverse events. The crossover design and moxifloxacin control are used to confirm the study can detect small changes in cardiac repolarization and to compare balinatunfib's effect against known standards.

Who should consider this trial

Good fit: Healthy men and women aged 18–55 with normal exams, ECGs and labs, within specified weight and BMI ranges, not pregnant or breastfeeding and using effective contraception as required are eligible.

Not a fit: People with known heart disease, abnormal ECGs, significant systemic illness, recent blood donation, frequent migraines, drug hypersensitivity, or those outside the weight/BMI or age ranges are unlikely to benefit from participation.

Why it matters

Potential benefit: If results show balinatunfib does not adversely affect cardiac repolarization, it would support safer progression to later clinical testing.

How similar studies have performed: Thorough QT-style single-dose crossover studies using moxifloxacin as a positive control are a standard, validated approach and have reliably characterized QT effects for many drugs.

Eligibility criteria

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.

Where this trial is running

Dallas, Texas and 1 other locations

• FORTREA CLINICAL RESEARCH UNIT INC- Site Number : 8400002 — Dallas, Texas, United States (Recruiting)
• FORTREA CLINICAL RESEARCH UNIT INC- Site Number : 8400001 — Madison, Wisconsin, United States (Recruiting)

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)

Conditions Cardiac Repolarization; Healthy Volunteers