Overview
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
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.