NCT07518121

A Bridging Study of Efsubaglutide Alfa in Healthy Adults in Brazil

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase I, randomized, double-blind, placebo-controlled, single-dose, parallel-group study in healthy adult participants in Brazil to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of YN-011 following subcutaneous administration. The study will be conducted at a single clinical study site in Brazil and will enroll approximately 48 healthy adult participants. Participants will be randomized into 2 dose cohorts, a 1 mg cohort and a 3 mg cohort. Within each cohort, participants will be randomized in a 5:1 ratio to receive a single subcutaneous dose of YN-011 or matching placebo. Overall, the study will include 3 treatment groups: YN-011 1 mg, YN-011 3 mg, and placebo. The placebo will be matched in appearance and administered using the same device format in order to maintain blinding. The main objectives of the study are to assess the safety and tolerability of YN-011 after single-dose administration in healthy adult participants, to characterize its PK profile, to evaluate selected PD effects, and to assess immunogenicity. Safety evaluations will include adverse events, clinical laboratory tests, vital signs, electrocardiograms, physical examinations, and other appropriate clinical assessments. PK assessments will characterize the concentration-time profile of YN-011 after dosing. PD assessments will evaluate the biologic effects of YN-011 after administration. Immunogenicity assessments will evaluate whether participants develop an immune response to YN-011. The study includes a screening period of up to 4 weeks, a study-site confinement period of approximately 2 days, and an outpatient follow-up period of 4 weeks, for a maximum total study duration of approximately 8 weeks per participant. Participants will be admitted to the clinical study site on the day before dosing and will undergo pre-dose assessments to confirm continued eligibility. On Day 1, participants will receive a single subcutaneous injection of YN-011 1 mg, YN-011 3 mg, or matching placebo in the abdomen using a prefilled auto-injector. During the confinement period, participants will remain under close clinical observation and will receive a controlled diet with specified fasting and fluid intake restrictions around dosing. After completion of the post-dose confinement period, participants will be discharged from the clinical study site and will return for scheduled outpatient follow-up visits for PK blood sampling, safety monitoring, PD evaluations, and immunogenicity assessments. The results of this study are expected to provide clinical information on the safety, PK, PD, and immunogenicity profile of single-dose YN-011 in healthy adult participants in Brazil.

Conditions

• Diabete Type 2

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2026-08-01
• Completion: 2026-10-31
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

1 site across 1 country: Brazil