NCT04067947

Phase 1 Pharmacokinetics, Safety, and Tolerability Study

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Oral Dose Study of the Pharmacokinetics, Safety, and Tolerability of XG005 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Xgene Pharmaceutical Group · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Oral Dose Study of the Pharmacokinetics, Safety, and Tolerability of XG005 in Healthy Volunteers.

Detailed description

This is a randomized, double-blind, placebo-controlled study which will investigate the PK, safety, and tolerability of four ascending single and multiple oral doses of XG005 in healthy subjects. The trial consists of two parts: a single ascending dose (SAD) PK evaluation (Part 1) and a multiple ascending dose (MAD) PK evaluation (Part 2). Approximately 32 Subjects will be enrolled sequentially into a total of 4 ascending dose levels in each part.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	XG005	XG005 Tablet
DRUG	Placebos	Placebo Tablet

Timeline

• Start date: 2019-07-08
• Primary completion: 2019-12-03
• Completion: 2020-02-10
• First posted: 2019-08-28
• Last updated: 2020-02-20

Locations

1 site across 1 country: Australia