First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug; LPX-TI641

Multiple Sclerosis Clinical Trial

Official title: A Phase I First in Human, Randomized, Double-blind, Placebo- Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability and Pharmacokinetics of LPX-TI641 After Single Oral Doses.

Status Recruiting

Clinical Trial Summary

A Phase I First-in-Human, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability, and Pharmacokinetics after Single Oral Dose of LPX-TI641.

Clinical Trial Description

This is a first-in-human, multi center, randomized, double-blinded, single ascending doses (SAD) Phase I study in healthy adult volunteers (HV). The study will consist of six cohorts (Cohorts 1 to 6) of eight HV subjects administered study drug (LPX-TI641/treatment or placebo oral solution) randomized in a 3:1 ratio (6 treatment + 2 placebo) in each cohort (Total 48 HV). Additional cohorts may be enrolled if deemed appropriate by the Sponsor to repeat a dose level or study another dose level based on the observed safety and PK data from the previous cohorts. Each entire cohort of 8 HV subjects will be enrolled at the same site. ;

Related Conditions & MeSH terms

• Autoimmune Diseases
• Multiple Sclerosis

• NCT number: NCT05853835
• Study type: Interventional
• Source: LAPIX Therapeutics Inc.
• Contact: LAPIX Therapeutics Inc.
• Phone: 6172035516
• Email: lpx641-101@lapixtherapeutics.com
• Status: Recruiting
• Phase: Phase 1
• Start date: October 30, 2023
• Completion date: August 1, 2024