A Bridging Study of Efsubaglutide Alfa in Healthy Adults in Brazil

Korábbi kezelés

• 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.
• 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.
• Donation or loss of ≥400 mL of blood within 3 months prior to screening.
• History of drug abuse within 1 year prior to screening, or positive drug abuse screening test (including amphetamines (AMP), cocaine (COC), tetrahydrocannabinol (THC), morphine (MOP), benzodiazepines (BZO), and methamphetamines (MET), any one or more of which tested positive).
• Consumption of more than 14 units of alcohol per week within 6 months prior to screening (1 unit of alcohol equivalent to 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine), or consumption of alcohol-containing products within 48 hours before administration, or positive breath alcohol test before administration.
• Participation in other clinical trials of vaccines, medical devices, or other drugs within 12 months prior to screening
• Major surgery within 4 weeks prior to screening, or planned major surgery during the study.

Más betegség

• 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.
• History or presence of hepatic, renal, cardiovascular, neurological, psychiatric, psychological or immunological disorders.
• 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).
• Participant with systolic blood pressure (SBP) < 90 mmHg or > 140 mmHg, or diastolic blood pressure (DBP) < 50 mmHg or > 90 mmHg after resting in a sitting position, or heart rate (HR) < 50 beats per minute (BPM) or > 100 bpm at rest in sitting position at the screening.

Laborértékek

• 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).
• 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.
• 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).

Egyéb

• Pregnant or breastfeeding women.
• Any other factors that may affect participation in this study at the discretion of the investigator.

• 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.