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.
Healthy male or female adults, aged 18-45 years (both inclusive) at the time of signing the informed consent form (ICF).
Body mass index (BMI) between 18-28 kg/m2 (both inclusive). Male participants must weigh no less than 50 kg, and female participants must weigh no less than 45 kg.
Voluntary participation in this study, as documented by the written signature of two copies of the ICF.
Negative serum pregnancy test for women of childbearing potential (WOCBP) during screening period. WOCBP and fertile male participants with WOCBP partners must use highly effective contraception methods without planning to become pregnant or to donate sperm or eggs throughout this study (from signing the ICF to at least 3 months after completion of this study).
Known or suspected allergy to the investigational medicinal product, its components or drugs of the same class, or a clinically significant drug allergy, or a history of atopic allergic disease.
FPG ≥126 mg/dL or ≥7.0 mmol/L ;
FPG 100-125 mg/dL or 5.6 -6.9 mmol/L (prediabetes);
HbA1c ≥ 6.5% or ≥48 mmol/mol;
Parallel
Efsubaglutide Alfa Injection
DrugEfsubaglutide 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.
Placebo
DrugMatching 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.
Maximum Observed Plasma Concentration (Cmax) of YN-011
Time to Maximum Observed Plasma Concentration (Tmax) of YN-011
Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of YN-011
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of YN-011
Incidence and severity of adverse events
Incidence and severity of adverse events, including treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Clinically significant changes in vital signs, clinical laboratory tests, and 12-lead electrocardiograms
Clinically significant changes in vital signs, clinical laboratory tests, including hematology, biochemistry, amylase, lipase, and urinalysis, and 12-lead electrocardiograms.
Change from baseline in fasting plasma glucose
Change From Baseline in Body Weight
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