NCT05441904

Study to Assess the Safety, Tolerability, and Pharmacokinetics of PXL770 in Healthy Subjects.

A Phase I, Two-part, Single and Optional Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of 500 and 750 mg PXL770 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Poxel SA · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study was planned in 2 parts: Parts A and B. In Part A, we tested 2 single doses of the study medicine in healthy volunteers: 500 mg and 750 mg. Part B was an optional part to test once-daily doses of the study medicine in healthy volunteers. We aimed to assess the safety, tolerability find out the side effects and blood levels of the PXL770.

Conditions

• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	PXL770	A single dose of 500 and 750 mg was administered to each subject.

Timeline

• Start date: 2021-03-08
• Primary completion: 2021-03-29
• Completion: 2021-03-29
• First posted: 2022-07-01
• Last updated: 2022-07-01

Locations

1 site across 1 country: United Kingdom