A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.
NCT07272629 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2026-05-15
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.
Conditions
- Cardiac Repolarization
- Healthy Volunteers
Interventions
- DRUG
-
Balinatunfib
Pharmaceutical form: Tablet Route of administration: Oral
- DRUG
-
Pharmaceutical form: Tablet Route of administration: Oral
- DRUG
-
Pharmaceutical form: Tablet Route of administration: Oral
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-12-04
- Primary Completion
- 2026-05-28
- Completion
- 2026-06-08
- FDA Drug
- Yes
Countries
- United States
Study Locations
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