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

Sanofi

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers; Cardiac Repolarization

Treatments: Drug: Balinatunfib; Drug: Moxifloxacin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07272629

TES18591

U1111-1316-0289 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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44 participants in 4 patient groups, including a placebo group

Balinatunfib Treatment A

Experimental group

Description:

Participants will receive a single oral dose of balinatunfib.

Treatment:

Drug: Placebo

Drug: Balinatunfib

Balinatunfib Treatment B

Experimental group

Description:

Participants will receive a single oral dose of balinatunfib.

Treatment:

Drug: Placebo

Drug: Balinatunfib

Moxifloxacin Treatment C

Active Comparator group

Description:

Participants will receive a single oral dose of moxifloxacin.

Treatment:

Drug: Placebo

Drug: Moxifloxacin

Placebo Treatment D

Placebo Comparator group

Description:

Participants will receive a single oral dose of balinatunfib matching placebo and moxifloxacin matching placebo.

Treatment:

Drug: Placebo