RecruitingPhase 1NCT07272629

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

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.

Sponsor

Sanofi

Enrollment

44 participants

Start Date

Dec 4, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteers Cardiac Repolarization

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria4

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 Criteria25

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.