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

NCT04809818 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-03-02

Study results available
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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.

Conditions

  • Acute Ischemic Stroke

Interventions

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

Sponsors & Collaborators

  • Lumosa Therapeutics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Mimi Yeh, PhD · Lumosa Phase 1 unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-21
Primary Completion
2021-08-05
Completion
2021-08-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04809818 on ClinicalTrials.gov