Healthy male or female participants, aged 18 to 55 years (inclusive at the time of informed consent)
Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and/or before administration of study drug
Participants must have a BMI greater than or equal to 20.0 kg/m2 and less than or equal to 35.0 kg/m2 and weigh greater than or equal to 50 kg but less than or equal to 90 kg at Screening
Stable body weight for at least three (3) months prior to Screening (i.e., <5% change)
Participants must have A1c below 6.4%, FPG: 3.9 ~ 6.1 mmol/L (both inclusive) or 70~110 mg/dL (both inclusive). All other clinical laboratory values must be within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or delegate
Non-smoker and/or casual smoker who uses no more than 10 cigarettes (or equivalent quantity of any other nicotine containing products e.g., cigars, chewing tobacco, snuff, etc.) per week. Participants must abstain from smoking 5 days prior to admission and throughout the confinement period, and test negative on Day -1 for urine cotinine test. Participants must also abstain from smoking 72 hours prior to each outpatient visit
Participants must agree to abstain from alcohol intake from 48 hours prior to admission and during the confinement period
Women of childbearing potential (WOCBP) must be non-pregnant and must use an acceptable, highly effective double contraception from Screening until study completion, including the follow up period
Males must not donate sperm for at least 90 days after the last dose of study drug
Participants must have the ability and willingness to attend the necessary visits to the CRU
Participants must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures
Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, may require treatment or render the participant unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures or interfere with study assessments
Confirmed diagnosis of diabetes mellitus type 1, type 2, or of any other forms at any time, and/or occurrence of documented or suspected hypoglycaemic episodes within 12 months prior to Screening
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
History of acute or chronic pancreatitis
Participants must be willing not to undertake any strenuous exercise, including but not limited to weightlifting (greater than 5 times per week) within 5 days prior to first study drug administration and for the duration of the study (including the follow-up period)
Participants must not start or having started participation in any medical (e.g., assisted by a clinical dietician or nutritionist) or non-medical (e.g., by a gym coach) diet and/or exercise programme within 3 months prior to Screening and for the duration of the study (including the follow-up period)
Use and/or planned use of any approved or unapproved weight-lowering medication(s) (including but not limited to orlistat, sibutramine, rimonabant, phentermine, or liraglutide) and/or medical device(s) within 3 months prior to Screening and for the duration of the study (including the follow-up period)
Previous history of any major gastrointestinal (including hepatobiliary and/or pancreatic) surgeries, including but not limited to sleeve, subtotal, or total gastrectomy, gastrojejunostomy, gastroduodenectomy, gastroduodenostomy, jejunectomy, ileectomy (proto)colectomy, hepatectomy, and pancreatectomy (except for appendectomy or cholecystectomy) and planned performance of one or more of the above mentioned for the duration of the study (including the follow-up period)
Yes for Previous history of any major gastrointestinal (including hepatobiliary and/or pancreatic) surgeries, including but not limited to sleeve, subtotal, or total gastrectomy, gastrojejunostomy, gastroduodenectomy, gastroduodenostomy, jejunectomy, ileectomy (proto)colectomy, hepatectomy, and pancreatectomy (except for appendectomy or cholecystectomy) and planned performance of one or more of the above mentioned for the duration of the study (including the follow-up period) exclusion criteria 8
No for Previous history of any major gastrointestinal (including hepatobiliary and/or pancreatic) surgeries, including but not limited to sleeve, subtotal, or total gastrectomy, gastrojejunostomy, gastroduodenectomy, gastroduodenostomy, jejunectomy, ileectomy (proto)colectomy, hepatectomy, and pancreatectomy (except for appendectomy or cholecystectomy) and planned performance of one or more of the above mentioned for the duration of the study (including the follow-up period) exclusion criteria 8
Not sure for Previous history of any major gastrointestinal (including hepatobiliary and/or pancreatic) surgeries, including but not limited to sleeve, subtotal, or total gastrectomy, gastrojejunostomy, gastroduodenectomy, gastroduodenostomy, jejunectomy, ileectomy (proto)colectomy, hepatectomy, and pancreatectomy (except for appendectomy or cholecystectomy) and planned performance of one or more of the above mentioned for the duration of the study (including the follow-up period) exclusion criteria 8
History of cerebral stroke (including but not limited to cerebral infarction/haemorrhage) within 12 months prior to Screening
History of acute coronary syndrome (angina pectoris/myocardial infarction) and any other major cardiac conditions (including but not limited to myocarditis, cardiac insufficiency/failure, and any clinically significant arrythmia[s]) within 12 months prior to Screening
Systolic blood pressure (BP) greater than 140 mmHg and/or less than 90 mmHg and/or diastolic BP greater than 90 mmHg and/or less than 40 mmHg and/or pulse rate greater 100 bpm and/or less than 40 bpm at Screening with one repeat allowed per by the Investigator or delegate at Screening and/or on Admission
Any clinically significant arrhythmia(s) at Screening ECG; specifically, the participant's corrected QT interval (QTcF) (Fridericia's correction) is greater than 450 ms at Screening and on Day -1. An out-of-range or abnormal ECG may be repeated during Screening. On admission, three ECGs should be recorded consecutively, and the Investigator must evaluate the triplicate ECG. If the participant's QTcF is greater than 450 ms on at least two ECGs, the participant must be excluded
Any medically uncontrolled respiratory disease(s) and/or condition(s), including but not limited to severe current asthma, chronic obstructive pulmonary disease, and obstructive sleep apnoea syndrome
Fever (body temperature greater than 38C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening
Clinically significant gastrointestinal disease(s), including but not limited to inflammatory bowel disease, irritable bowel syndrome, celiac disease, dyspepsia, apparent diabetic gastroparesis, and diabetic diarrhoea
With alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or alkaline phosphatase (ALP) greater than 1.5 upper limit of normal (ULN) at Screening. Repeat testing at Screening is acceptable for out of range values following approval by the Investigator or delegate
With a confirmed creatinine clearance (CLcr) using the Cockcroft-Gault equation below 90 mL/min. Repeat testing at Screening is acceptable for out of range values following approval by the Investigator or delegate
History of clinically significant endocrine condition(s), including but not limited to hyper/hypothyroidism and/or hyper/hypoadrenalism
History of primary or recurrent malignancy, except for non-melanoma skin cancer excised more than 2 years prior to Screening and/or cervical intraepithelial neoplasia having been successfully cured more than 5 years prior to Screening
With clinically significant haematologic abnormalities, including but not limited to haemoglobin above 180 g/L and/or below 110 g/L, white blood cell count (WBC) above 10.510^9/L and/or below 3.510^9/L, absolute neutrophil count above 7.010^9/L and/or below 2.010^9/L, and/or platelet count above 30010^9/L and/or below 13010^9/L. Repeat testing at Screening is acceptable for out of range values following approval by the Investigator or delegate
With any other clinically significant laboratory abnormalities in clinical biochemistry, coagulation function, and/or urinalysis. Repeat testing at Screening is acceptable for out of range values following approval by the Investigator or delegate
With positive test result(s) for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening
History of life-threatening infection (e.g. meningitis) and/or any major infections requiring parental antimicrobials within 6 months prior to Screening
Regular alcohol consumption (by self-declaration) defined as greater than 21 alcohol units per week (where 1 unit = 284-mL of beer, 25-mL of 40% spirit or a 125-mL glass of wine). Participant is unwilling to abstain from alcohol beginning 48 hours prior to admission to the CRU and during the confinement period
With a history of substance abuse or dependency in the last 12 months, or a history of recreational intravenous drug use over the last 5 years (by self-declaration);with a positive toxicology screening panel (urine test including qualitative identification of barbiturates, tetrahydrocannabinol [THC], amphetamines, methamphetamines, methylenedioxy-methamphetamine [MDMA], phencyclidine, benzodiazepines, opiates and cocaine), or alcohol breath test
History of severe allergic or anaphylactic reactions
Known or suspected intolerance or hypersensitivity to the IP, close related compounds, or any of the stated ingredients
Blood donation or significant blood loss (greater than or equal to 400 mL) within 60 days prior to the first study drug administration
Plasma donation within 7 days prior to the first study drug administration
Being pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study and for at least 3 months after the last dose of study drug
Use of any IP or investigational medical device within 30 days prior to Screening, or 5 half lives of the product (whichever is the longest) or participation in more than four investigational drug studies within 1 year prior to Screening
Previous treatment with glucagon-like peptide 1 (GLP-1) agonists within the last 3 months
Use of any prescription drug(s) and medical device(s) (other than hormonal
contraception
OCPs, long-acting implantable hormones, injectable hormones, a vaginal ring
or an IUD) within 2 weeks prior to the first study drug dosing or use of any
over the-counter (OTC) medication, herbal remedies, supplements or vitamins
within 1 week prior to the first study drug dosing and during the course of
the study without prior approval of the Investigator and MM. Use of simple
analgesic(s) (e.g., paracetamol, a nonsteroidal anti-inflammatory drug
[NSAID]) may be permitted at the discretion of the Investigator
\. Present comedication with drugs known to interfere with glucose
metabolism, such as systemic corticosteroids, non-selective beta-blockers, and
monoamine oxidase inhibitors
\. Presence of any underlying physical and/or psychological medical
condition that, in the opinion of the Investigator, would make it unlikely
that the subject will comply with the protocol or complete the study per
protocol