NCT04695041

A Healthy Volunteer Study of PBI-4050

A Phase 1, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of PBI-4050 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Liminal BioSciences Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the study drug PBI-4050 to determine the safety, tolerability and concentration profile in the blood when the drug is given to healthy volunteers as multiple doses and different dosing regimens over a period of 14 days.

Conditions

• Fibrosis
• Inflammation

Interventions

Type	Name	Description
DRUG	PBI-4050/ Placebo	Participants receive either 800mg PBI-4050 capsules or placebo, twice a day for 14 days
DRUG	PBI-4050/ Placebo	Participants receive either 1200mg PBI-4050 capsules or placebo, once a day for 14 days
DRUG	PBI-4050/ Placebo	Participants receive either 1000 mg PBI-4050 capsules or placebo, twice a day for 14 days
DRUG	PBI-4050/ Placebo	Participants receive either 1200 mg PBI-4050 capsules or placebo, twice a day for 14 days
DRUG	PBI-4050/ Placebo	Participants receive either 800 mg PBI-4050 capsules or placebo, three times a day for 14 days

Timeline

• Start date: 2020-12-09
• Primary completion: 2021-10-05
• Completion: 2021-10-05
• First posted: 2021-01-05
• Last updated: 2021-11-30

Locations

1 site across 1 country: United Kingdom