NCT04809818

A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects

Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of LT3001 Drug Product and Drug-Drug Interaction in Healthy Adult Subjects

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

Summary

This Phase 1 study is planned to establish the clinical safety and pharmacokinetics profile of multiple dose of LT3001 drug product and to investigate drug interactions of LT3001 with potential concomitant medications in healthy subjects.

Detailed description

This study is a two-part study. Part A is double-blind, placebo-controlled, and will examine the safety and PK profiles of multiple doses of LT3001 drug product in healthy subjects. Part B is open-label and will assess the safety and PK of LT3001 when coadministered with aspirin, clopidogrel, apixaban or dabigatran.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	LT3001 drug product	Multiple doses of LT3001 drug product administered by intravenous infusion
DRUG	Placebo	Multiple doses of Placebo administered by intravenous infusion
DRUG	Aspirin	Loading and maintenance doses of Aspirin administered by oral
DRUG	Clopidogrel	Loading and maintenance doses of Clopidogrel administered by oral
DRUG	Apixaban	Multiple doses of Apixaban administered by oral
DRUG	Dabigatran	Multiple doses of Dabigatran administered by oral

Timeline

• Start date: 2021-03-21
• Primary completion: 2021-08-05
• Completion: 2021-08-05
• First posted: 2021-03-22
• Last updated: 2026-03-02
• Results posted: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study