Actively Recruiting

Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
NCT07272629

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

Led by Sanofi · Updated on 2026-01-13

44

Participants Needed

2

Research Sites

20 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy males and females aged 18 to 55 years at consent signing
  • Certified healthy by medical history, physical exam, vital signs, ECG, and laboratory tests with no abnormalities
  • Weight between 50-100 kg for males and 40-90 kg for females
  • Body mass index (BMI) between 18 and 30 kg/m8
  • Males must use effective contraception or abstain from sperm donation for 3 months after dosing
  • Females must use highly effective contraception, not be pregnant or breastfeeding, and test negative for pregnancy before treatment
Not Eligible

You will not qualify if you...

  • History of significant systemic diseases including hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiac, hepatic, psychiatric, neurologic, infectious, or allergic conditions except mild seasonal allergies
  • Clinically significant ECG abnormalities
  • Frequent headaches, migraines, or recurrent nausea/vomiting more than twice monthly
  • Blood donation within 2 months prior to study
  • Symptomatic or significant postural hypotension
  • Known drug hypersensitivity or significant allergies, including to study drugs
  • History of drug or alcohol abuse
  • Tobacco use within 3 months before Day 1
  • History of Hepatitis B or C, tuberculosis, or invasive opportunistic infections
  • Malignancy within 5 years except treated non-metastatic skin cancer
  • Adverse reaction to balinatunfib, moxifloxacin, or quinolones
  • Use of any medication (except hormonal contraception or hormone replacement therapy) within 14 days or five half-lives before dosing
  • Use of biologics within 4 months prior
  • Vaccinations: non-live within 4 weeks, live within 3 months before or during study
  • Participation in another interventional study within 30 days
  • Positive tests for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, HIV 1/2 antibodies
  • Positive urine drug screen
  • Positive alcohol breath test
  • Positive urine cotinine test
  • History of long QT syndrome or risk factors for torsades de pointes
  • Contraindications to moxifloxacin
  • Low potassium (less than 3.5 mmol/L) or low magnesium (less than 0.7 mmol/L) levels

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

FORTREA CLINICAL RESEARCH UNIT INC- Site Number : 8400002

Dallas, Texas, United States, 75247

Actively Recruiting

2

FORTREA CLINICAL RESEARCH UNIT INC- Site Number : 8400001

Madison, Wisconsin, United States, 53704

Actively Recruiting

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Research Team

T

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

4

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