Clinical Trials/NCT07272629

NCT07272629

Recruiting

Phase 1

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.

Sanofi2 sites in 1 country44 target enrollmentDecember 4, 2025

InterventionsBalinatunfib Placebo Moxifloxacin

Overview

Phase: Phase 1
Intervention: Balinatunfib
Conditions: Not specified
Sponsor: Sanofi
Enrollment: 44
Locations: 2
Primary Endpoint: Change from baseline in the QT interval corrected using the Fridericia formula (QTcF) centrally assessed using a semi-automatic reading
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 4, 2025

End Date

April 27, 2026

Last Updated

3 months ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Sanofi

Responsible Party

Sponsor

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
•History of Hepatitis B/C, TB, or invasive opportunistic infections.
•Malignancy within 5 years (except treated non-metastatic skin cancer).

Arms & Interventions

Balinatunfib Treatment A

Participants will receive a single oral dose of balinatunfib.

Intervention: Balinatunfib

Balinatunfib Treatment A

Participants will receive a single oral dose of balinatunfib.

Intervention: Placebo

Balinatunfib Treatment B

Participants will receive a single oral dose of balinatunfib.

Intervention: Balinatunfib

Balinatunfib Treatment B

Participants will receive a single oral dose of balinatunfib.

Intervention: Placebo

Moxifloxacin Treatment C

Participants will receive a single oral dose of moxifloxacin.

Intervention: Moxifloxacin

Moxifloxacin Treatment C

Participants will receive a single oral dose of moxifloxacin.

Intervention: Placebo

Placebo Treatment D

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

Intervention: Placebo

Outcomes

Primary Outcomes

Change from baseline in the QT interval corrected using the Fridericia formula (QTcF) centrally assessed using a semi-automatic reading

Time Frame: Baseline to day 2

Secondary Outcomes

Change from baseline in QT interval corrected using the Bazett formula (QTcB)(Baseline to day 2 of each period)
Change from baseline in population specific QT correction (QTcN) interval(Baseline to day 2 of each period)
Change from baseline in QRS interval(Baseline to day 2 of each period)
Change from baseline in PR interval(Baseline to day 2 of each period)
Safety for electrocardiogram (ECG) parameters(Baseline to day 83)
Change from baseline in heart rate (HR)(Day 1 to Day 2)
Change from baseline in QT interval(Baseline to day 2 of each period)
Maximum plasma concentration (Cmax) for balinatunfib(Baseline to day 6 of each period)
Time to reach the maximum concentration (tmax) for balinatunfib(Baseline to day 6 of each period)
Area under the curve (AUC) for balinatunfib(Baseline to day 6 of each period)
Maximum plasma concentration (Cmax) for balinatunfib metabolite M8(Baseline to day 6 of each period)
Time to reach the maximum concentration (tmax) for balinatunfib metabolite M8(Baseline to day 6 of each period)
Area under the curve (AUC) for balinatunfib metabolite M8(Baseline to day 6 of each period)
Number of participants experiencing treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESIs) and serious adverse events (SAEs)(Baseline to Day 83)
Number of participants with clinical laboratory and vital signs abnormalities (potentially clinically significant abnormality)(Baseline to Day 83)