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NOT YET RECRUITING
NCT07518121
PHASE1

A Bridging Study of Efsubaglutide Alfa in Healthy Adults in Brazil

Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-Blind, Placebo-Controlled Bridging Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of Efsubaglutide Alfa in Healthy Adult Participants in Brazil

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-06-01

Completion Date

2026-10-31

Last Updated

2026-04-08

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Efsubaglutide Alfa Injection

Efsubaglutide alfa will be administered as a single subcutaneous injection at a dose of 1 mg or 3 mg on Day 1 in healthy adult participants. The study drug will be administered in the abdomen using a prefilled auto-injector.

DRUG

Placebo

Matching placebo will be administered as a single subcutaneous injection on Day 1 in healthy adult participants. Placebo is identical in appearance and presentation to efsubaglutide alfa and will be administered in the abdomen using a matching prefilled auto-injector.

Locations (1)

A2Z Clinical Centro Avançado de Pesquisa Clínica LTDA

Valinhos, São Paulo, Brazil