NCT07272629

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiac Repolarization
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Balinatunfib	Pharmaceutical form: Tablet Route of administration: Oral
DRUG	Moxifloxacin	Pharmaceutical form: Tablet Route of administration: Oral
DRUG	Placebo	Pharmaceutical form: Tablet Route of administration: Oral

Timeline

• Start date: 2025-12-04
• Primary completion: 2026-04-27
• Completion: 2026-04-27
• First posted: 2025-12-09
• Last updated: 2026-01-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study