A Bridging Study of Efsubaglutide Alfa in Healthy Adults in Brazil

NCT07518121 | Not Yet Recruiting Phase 1

• 1 other identifier: YN011-I-102-BR
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Efsubaglutide Alfa; Phase 1; Healthy Volunteers; Pharmacokinetics; Brazil; Bridging Study; GLP-1 Receptor Agonist

Outcome Measures

Primary Outcomes (5)

• Maximum Observed Plasma Concentration (Cmax) of YN-011

  Predose through Day 29

• Time to Maximum Observed Plasma Concentration (Tmax) of YN-011

  Predose through Day 29

• Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of YN-011

  Predose through Day 29

• Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of YN-011

  Predose through Day 29

• Terminal Elimination Half-Life (t1/2) of YN-011

  Predose through Day 29

Secondary Outcomes (10)

• Incidence and severity of adverse events

  From informed consent through Day 29

• Clinically significant changes in vital signs, clinical laboratory tests, and 12-lead electrocardiograms

  Baseline through Day 29

• Change from baseline in fasting plasma glucose

  Baseline through Day 29

• Change From Baseline in Body Weight

  Baseline through Day 29

• Incidence of anti-drug antibodies and neutralizing antibodies

  Baseline through Day 29

Study Arms (3)

YN-011 1mg

EXPERIMENTAL

Drug: Efsubaglutide Alfa Injection

YN-011 3mg

EXPERIMENTAL

Drug: Efsubaglutide Alfa Injection

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Efsubaglutide Alfa Injection DRUG

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.

YN-011 1mg; YN-011 3mg

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• Be able to maintain good communication with the investigators and comply with all requirements of protocol to complete all trial procedures.

You may not qualify if:

• 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.
• Previously or currently diagnosed diabetes mellitus (T1D or T2D) or prediabetes, according to the diagnostic criteria of the Brazilian Diabetes Society (SBD) guideline, defined by any of the following laboratory findings:
• 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;
• HbA1c 5.7-6.4% or 39-47 mmol/mol (prediabetes).
• History of clinically significant endocrine disorders that may affect glucose metabolism, body weight, or drug PK, including but not limited to Cushing's syndrome; acromegaly; pheochromocytoma; untreated or uncontrolled thyroid disorders (hyperthyroidism or hypothyroidism); polycystic ovary syndrome (PCOS) with metabolic abnormalities; adrenal insufficiency or other adrenal disorders; pituitary disorders affecting hormonal regulation.
• History of acute or chronic pancreatitis, symptomatic gallbladder disease (those who have recovered from cholecystectomy and have no sequelae after treatment are allowable to be enrolled), pancreatic injury or other high-risk factors that may lead to pancreatitis, or screening serum amylase or lipase \>2X upper limit of normal (ULN).
• History of significant gastrointestinal (GI) disorders (e.g., gastroparesis, active ulcers within 6 months, or long-term use of medications that directly affect GI motility, or GI surgery within 6 months prior to screening.
• History or presence of hepatic, renal, cardiovascular, neurological, psychiatric, psychological or immunological disorders.
• Clinically significant abnormalities in physical examination, vital signs, laboratory tests, or 12-lead ECG at screening, and investigators consider that these abnormalities may affect participant's safety or study results. ECG abnormalities including but not limited to: second- or third-degree atrioventricular block; long QT syndrome or QTcF \> 450 ms (males) or \> 470 ms (females). (If the QTcF \> 450 ms (males) or \> 470 ms (females), two additional ECG measurements should be repeated, and the mean of the three values should be used to determine the participant's eligibility.); left bundle branch block;Wolff-Parkinson-White syndrome; Or other clinically significant 12-lead ECG abnormalities requiring treatment.
• Use of any prescription or over-the-counter (OTC) medications, traditional Chinese medicine within 12 months prior to screening that may confound PK, PD, or safety assessments.
• Personal or family history of thyroid C-cell tumors including medullary thyroid carcinoma (MTC), or multiple endocrine neoplasia type 2 (MEN2), or presence of hyperthyroidism or hypothyroidism that has not been controlled with a stable medication dose (defined as a stable dose for at least 3 months or longer).
• Positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBSAg) and HBV-deoxyribonucleric adic (DNA) ≥ lab-specific ULN (for those with positive result on HBsAg, HBV-DNA test will be performed), hepatitis C antibody (HCV-Ab) and HCV-ribonucleric acid (RNA), participant can be eligible at the discretion of the investigator if HCV-Ab positive and HCV RNA negative, or Treponema pallidum antibody (TP-Ab).
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

A2Z Clinical Centro Avançado de Pesquisa Clínica LTDA

Valinhos, São Paulo, 13271-130, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Allen Guo

CONTACT

+86-13913843023; Yinghao.guo@innogenpharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)