A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in H… (NCT07272629) | Clinical Trial Compass
RecruitingPhase 1
A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.
United States44 participantsStarted 2025-12-04
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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 w…
What they're measuring
1
Change from baseline in the QT interval corrected using the Fridericia formula (QTcF) centrally assessed using a semi-automatic reading
Timeframe: Baseline to day 2
Trial details
NCT IDNCT07272629
SponsorSanofi
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2026-04-27
Contact for this trial
Trial Transparency email recommended (Toll free for US & Canada)