A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.
NCT ID: NCT07272629
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
44 participants
INTERVENTIONAL
2025-12-04
2026-04-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Balinatunfib Treatment A
Participants will receive a single oral dose of balinatunfib.
Balinatunfib
Pharmaceutical form: Tablet Route of administration: Oral
Placebo
Pharmaceutical form: Tablet Route of administration: Oral
Balinatunfib Treatment B
Participants will receive a single oral dose of balinatunfib.
Balinatunfib
Pharmaceutical form: Tablet Route of administration: Oral
Placebo
Pharmaceutical form: Tablet Route of administration: Oral
Moxifloxacin Treatment C
Participants will receive a single oral dose of moxifloxacin.
Moxifloxacin
Pharmaceutical form: Tablet Route of administration: Oral
Placebo
Pharmaceutical form: Tablet Route of administration: Oral
Placebo Treatment D
Participants will receive a single oral dose of balinatunfib matching placebo and moxifloxacin matching placebo.
Placebo
Pharmaceutical form: Tablet Route of administration: Oral
Interventions
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Balinatunfib
Pharmaceutical form: Tablet Route of administration: Oral
Moxifloxacin
Pharmaceutical form: Tablet Route of administration: Oral
Placebo
Pharmaceutical form: Tablet Route of administration: Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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FORTREA CLINICAL RESEARCH UNIT INC- Site Number : 8400002
Dallas, Texas, United States
FORTREA CLINICAL RESEARCH UNIT INC- Site Number : 8400001
Madison, Wisconsin, United States
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
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TES18591 Plain Language Results Summary
Other Identifiers
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U1111-1316-0289
Identifier Type: OTHER
Identifier Source: secondary_id
TES18591
Identifier Type: -
Identifier Source: org_study_id
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