A Bridging Study of Efsubaglutide Alfa in Healthy Adults in Brazil (NCT07518121) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Bridging Study of Efsubaglutide Alfa in Healthy Adults in Brazil
Brazil48 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Maximum Observed Plasma Concentration (Cmax) of YN-011
Timeframe: Predose through Day 29
2
Time to Maximum Observed Plasma Concentration (Tmax) of YN-011
Timeframe: Predose through Day 29
3
Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of YN-011
Timeframe: Predose through Day 29
4
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of YN-011
. 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:
✕. 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.