NCT05053165

A Study to Assess the Safety and Tolerability of LB-P6 and LB-P8 in Healthy Participants

A Phase 1, Randomised, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of LB-P6 or LB-P8 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: LISCure Biosciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study is designed to assess the safety and tolerability of multiple ascending doses of LB-P6 or LB-P8 in healthy participants.

Detailed description

This is randomised, double-blind, placebo-controlled, single centre study to assess the safety and tolerability of multiple ascending doses of LB-P6 or LB-P8 in healthy participants. A total of up to 30 healthy participants will be enrolled in 2 cohorts.

Conditions

• Rheumatoid Arthritis
• Non-Alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	LB-P6	Healthy subjects will be randomized to receive LB-P6 once daily orally
DRUG	LB-P8	Healthy subjects will be randomized to receive LB-P8 once daily orally
DRUG	Placebo	Healthy subjects will be randomized to receive placebo once daily orally

Timeline

• Start date: 2022-01-04
• Primary completion: 2022-04-01
• Completion: 2022-06-29
• First posted: 2021-09-22
• Last updated: 2022-09-06

Locations

1 site across 1 country: Australia