A Phase 1 Randomized, Placebo-Controlled, Single & Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of GLY-200 in Healthy Adult Subjects

Glyscend Pty Ltd0 sites64 target enrollmentJune 24, 2021

ConditionsType 2 Diabetes Metabolic and Endocrine - Diabetes

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Type 2 Diabetes
Sponsor: Glyscend Pty Ltd
Enrollment: 64
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 24, 2021

End Date

March 28, 2022

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Glyscend Pty Ltd

Eligibility Criteria

Inclusion Criteria

•1\.Male or female, greater than or equal to 18 and less than or equal to 65 years old at the time of screening, with BMI greater than and equal to 18\.0 and less than 32kg/m2
•2\.Subjects must be in good general health, with no significant medical history, have no clinically significant abnormalities in general physical examination, vital signs, laboratory tests (haematology, urinalysis, blood chemistry, coagulation function), and 12\-lead ECG as judged by the investigator at screening and baseline. If necessary, one repeat may be performed at the discretion of the investigator and the reason for repeat must be documented clearly.
•3\.Use of less than 5 tobacco or nicotine\-containing products daily for 1 month prior to screening and able to abstain from smoking during the trial.
•4\.Healthy as defined by:
•a.the absence of clinically significant illness and surgery within 12 weeks prior to administration. Subjects experiencing nausea within 24 hours pre\-administration will be carefully evaluated for upcoming illness/disease. Inclusion pre\-administration is at the discretion of the investigator.
•b.the absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, haematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease, including, but not limited to pancreatitis, hepatitis B or C, HIV, swallowing disorders, and gastroesophageal reflux disease (at least 1 episode per week).
•c.the absence of clinically significant history of gastric or peptic ulcer, small bowel resection (except if related to appendectomy), intestinal stricture (e.g., Crohn's disease), intestinal obstruction or high risk of intestinal obstruction including suspected small bowel adhesions and prior history of major abdominal surgeries.
•d.the absence of clinically significant history or known presence of oesophageal anatomic abnormalities (e.g., webs, diverticula, rings), dysphagia, gastroparesis, and malabsorption.
•e.the absence of history of gastric bypass, any other gastric surgery and intragastric balloon.
•f.the absence of history of angina, coronary bypass, and myocardial infarction within 6 months prior to administration.

Exclusion Criteria

•1\.History of clinically significant endocrine, neurological, cardiovascular, haematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
•2\.Mentally or legally incapacitated, has significant emotional problems at the time of Screening Visit or expected during the conduct of the study, or has severe, active psychiatric conditions that require ongoing treatment, or that would impact the subject’s ability to participate in the trial in the opinion of the Investigator.
•3\.Severe infections, injuries or major surgeries and prior history of major abdominal surgeries (as determined by the investigator) within 4 weeks prior to screening or intend to undergo any surgery during the trial.
•4\.Use of a live vaccine within 30 days prior to screening or anticipated need for a live vaccine during the study or for 30 days following the last dose of study drug.
•6\.History of bleeding associated with procedures such as endoscopy or phlebotomy; or use of medications such as nonsteroidal anti\-inflammatory drugs (NSAIDS) or aspirin within 28 days prior to screening or planned use during the study.
•7\.Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
•8\.Any history of gastrointestinal disease including inflammatory bowel disease, toxic megacolon, dysphagia, gastroesophageal reflux disease (GERD), colon cancer, intestinal stenosis, or fistula.
•9\.Any GI symptoms occurring greater than or equal to 1 day per week (including gastroesophageal reflux) as per the Digestive health and wellbeing survey questionnaire will be exclusionary. The final decision will be at the discretion of the PI in consultation with the MM if there are any borderline cases or some uncertainty exists during screening.
•10\.Subjects with a history of severe allergy to any drug, food, toxin or other exposure.
•11\.Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities