A Randomized, Double-blind, Placebo- controlled, Single Ascending Dose (SAD) Study of XW003 Injection in Healthy Adult Participants
- Conditions
- Type 2 Diabetes MellitusNonalcoholic SteatohepatitisMetabolic and Endocrine - DiabetesMetabolic and Endocrine - Other metabolic disorders
- Registration Number
- ACTRN12620000344998
- Lead Sponsor
- Sciwind Biosciences APAC CO Pty. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 50
To be eligible for this study, a participant has to meet all of the following inclusion criteria:
1.Healthy male or female participants, aged 18 to 55 years (inclusive at the time of informed consent);
2.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;
3.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;
4.Stable body weight for at least three (3) months prior to Screening (i.e., <5% change);
5.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;
6.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;
7.Participants must agree to abstain from alcohol intake from 48 hours prior to admission and during the confinement period;
8. 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.
9.Males must not donate sperm for at least 90 days after the last dose of study drug;
10. Participants must have the ability and willingness to attend the necessary visits to the CRU;
11. 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.
1.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;
2.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;
3.Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2;
4.History of acute or chronic pancreatitis;
5.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);
6.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);
7.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);
8.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);
9.History of cerebral stroke (including but not limited to cerebral infarction/haemorrhage) within 12 months prior to Screening;
10.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;
11. 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
12. 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;
13.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;
14.Fever (body temperat
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method