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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.

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
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
View Details
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