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

NCT07272629

CompletedPhase 1

Sponsor: Sanofi

Conditions: Cardiac Repolarization, Healthy Volunteers

Interventions: Balinatunfib, Moxifloxacin, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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 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.

Locations (2)

Dallas, Texas, United States
Madison, Wisconsin, United States