Obesity Clinical Trial
Official title:
A Phase 1, Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of XW003 Injection in Healthy Adult Participants
XW003 is an acylated human GLP-1 analogue and is being development for diabetes mellitus, obesity and nonalcoholic steatohepatitis (NASH) management. This is a first-in-human (FIH), single-centre, double blind, randomised, SAD and MAD study of XW003 conducted in healthy adult participants. The study is designed to evaluate the safety, tolerability, PK, and PD of XW003 in healthy adult participants.
Participants will undergo a Screening period beginning up to 28 days prior to randomisation/dose administration. Participants will undergo pre-dose assessments, post-dose assessments, and will complete an EOS follow-up visit or early termination (ET) visit. Up to 42 participants will be enrolled into one of up to six (6) sequential cohorts (Cohorts A1 to A6). Participants in each cohort will be randomised to receive a single subcutaneous (SC) dose of either XW003 or matching placebo on Day 1 following an overnight fast. Two sentinel participants will receive a single SC dose of XW003 initially. If dosing of these sentinel participants proceeds without clinically significant safety signals in the first 48 hours post-dose, the remaining participants will receive a single dose of XW003 or placebo according to the randomisation schedule. Participants in Cohorts B1 to B3 (n=10 per cohort) will be randomized to receive a single SC dose of either XW003 (n=8) or matching placebo (n=2) once weekly for 6 weeks. Doses will be administered following an overnight fast of at least 10 hours. ;
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