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A Bridging Study of Efsubaglutide Alfa in Healthy Adults in Brazil

NCT07518121 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

  • Diabete Type 2

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.

Sponsors & Collaborators

  • Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-08-01
Completion
2026-10-31

Countries

  • Brazil

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07518121 on ClinicalTrials.gov