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.
Sanofi
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
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DrugBalinatunfib
Pharmaceutical form: Tablet Route of administration: Oral
- DrugMoxifloxacin
Pharmaceutical form: Tablet Route of administration: Oral
- DrugPlacebo
Pharmaceutical form: Tablet Route of administration: Oral
Locations (2)
- FORTREA CLINICAL RESEARCH UNIT INC- Site Number : 8400002Dallas, Texas
- FORTREA CLINICAL RESEARCH UNIT INC- Site Number : 8400001Madison, Wisconsin