Clinical Trial

A Bridging Study of Efsubaglutide Alfa in Healthy Adults in Brazil

Study acronym: BRIDGE-BR
Not Yet Recruiting Phase 1
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Record status
This record was last updated April 8, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a Phase I, randomized, double-blind, placebo-controlled, single-dose study in healthy adult participants in Brazil to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of YN-011. Participants will be randomized to receive a single subcutaneous dose of YN-011 1 mg, YN-011 3 mg, or matching placebo. The study includes screening, approximately 2 days of study-site confinement from the day before dosing to 24 hours after dosing, and outpatient follow-up for 4 weeks. Assessments include safety monitoring, PK blood sampling, PD evaluations, and immunogenicity testing.
Trial Details
NCT Number NCT07518121
Lead Sponsor Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Conditions Diabete Type 2
Enrollment 48 participants
Start Date 2026-06-01
Primary Completion 2026-08-01 (estimated)
Study Completion 2026-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-08