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 and Multiple 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 and Multiple Oral Dose of LPX-TI641.

Clinical Trial Description

This is a first-in-human, multi center, randomized, double-blinded, single and multiple ascending doses (SAD and MAD) Phase I study in healthy adult volunteers (HV).

The SAD cohorts will consist of six cohorts of eight participants (6 randomized to treatment + 2 randomized to placebo) in each cohort (Total 48 HV). Additional cohorts may be added.

The MAD cohorts will consist of 3 cohorts of eight participants (6 randomized to treatment + 2 randomized to placebo) in each cohort (Total 24 HV). The subjects in MAD cohorts will be dosed once daily for 7 consecutive days. Additional cohorts may be added.

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: November 1, 2024