XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

XW004 is an acylated human glucagon-like peptide 1 (GLP-1) analogue and is being developed for type 2 diabetes mellitus (T2DM) and obesity management.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sciwind Biosciences APAC CO Pty. Ltd.
• Collaborator: Hangzhou Sciwind Biosciences Co., Ltd.

Criteria

Inclusion Criteria:

• Healthy male or female participants, aged 18 to 55 years (inclusive at the time of informed consenting);

• Participants must be in good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before administration of study drug;

• Stable body weight for at least 3 months prior to Screening (i.e., <5% change) by self-declaration;

Exclusion Criteria:

• 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 investigational product (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;