NCT07272629CompletedPhase 1
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.
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Change from baseline in the QT interval corrected using the Fridericia formula (QTcF) centrally assessed using a semi-automatic reading
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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 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
- •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/
- •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.
Arms & Interventions
Moxifloxacin Treatment C
Active Comparator
Participants will receive a single oral dose of moxifloxacin.
Intervention: Placebo (Drug)
Moxifloxacin Treatment C
Active Comparator
Participants will receive a single oral dose of moxifloxacin.
Intervention: Moxifloxacin (Drug)
Placebo Treatment D
Placebo Comparator
Participants will receive a single oral dose of balinatunfib matching placebo and moxifloxacin matching placebo.
Intervention: Placebo (Drug)
Balinatunfib Treatment A
Experimental
Participants will receive a single oral dose of balinatunfib.
Intervention: Placebo (Drug)
Balinatunfib Treatment B
Experimental
Participants will receive a single oral dose of balinatunfib.
Intervention: Placebo (Drug)
Balinatunfib Treatment A
Experimental
Participants will receive a single oral dose of balinatunfib.
Intervention: Balinatunfib (Drug)
Balinatunfib Treatment B
Experimental
Participants will receive a single oral dose of balinatunfib.
Intervention: Balinatunfib (Drug)
Outcomes
Primary Outcomes
Change from baseline in the QT interval corrected using the Fridericia formula (QTcF) centrally assessed using a semi-automatic reading
Time Frame: Baseline to day 2
Secondary Outcomes
- Change from baseline in QT interval corrected using the Bazett formula (QTcB)(Baseline to day 2 of each period)
- Change from baseline in population specific QT correction (QTcN) interval(Baseline to day 2 of each period)
- Change from baseline in QRS interval(Baseline to day 2 of each period)
- Change from baseline in PR interval(Baseline to day 2 of each period)
- Safety for electrocardiogram (ECG) parameters(Baseline to day 83)
- Change from baseline in heart rate (HR)(Day 1 to Day 2)
- Change from baseline in QT interval(Baseline to day 2 of each period)
- Maximum plasma concentration (Cmax) for balinatunfib(Baseline to day 6 of each period)
- Time to reach the maximum concentration (tmax) for balinatunfib(Baseline to day 6 of each period)
- Area under the curve (AUC) for balinatunfib(Baseline to day 6 of each period)
- Maximum plasma concentration (Cmax) for balinatunfib metabolite M8(Baseline to day 6 of each period)
- Time to reach the maximum concentration (tmax) for balinatunfib metabolite M8(Baseline to day 6 of each period)
- Area under the curve (AUC) for balinatunfib metabolite M8(Baseline to day 6 of each period)
- Number of participants experiencing treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESIs) and serious adverse events (SAEs)(Baseline to Day 83)
- Number of participants with clinical laboratory and vital signs abnormalities (potentially clinically significant abnormality)(Baseline to Day 83)
Investigators
Study Sites (2)
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