NCT04966832

Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults

A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: XWPharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of XW10508 in healthy volunteers.

Detailed description

This is a first-in-human single and multiple ascending oral dose pharmacokinetic and safety study where participants will receive either XW10508 or placebo. Both immediate release and modified release formulations will be assessed. Timed blood samples will be collected to assess the pharmacokinetics after the study drug is ingested by the participants.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	XW10508	XW10508 capsules or tablets
OTHER	Placebo	Placebo capsules or tablets

Timeline

• Start date: 2021-07-13
• Primary completion: 2022-06-13
• Completion: 2022-06-13
• First posted: 2021-07-19
• Last updated: 2022-11-04

Locations

1 site across 1 country: Australia