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

  • STATUS
    Recruiting
  • days left to enroll
    88
  • participants needed
    64
  • sponsor
    Lumosa Therapeutics Co., Ltd.
Updated on 28 March 2021

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.

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.

Details
Condition Acute Ischemic Stroke
Treatment Clopidogrel, Placebo, Aspirin, Apixaban, Dabigatran, LT3001 Drug Product
Clinical Study IdentifierNCT04809818
SponsorLumosa Therapeutics Co., Ltd.
Last Modified on28 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject's body weight is 50 kg and BMI is within the range of 18 to 32
Subject is a healthy volunteer
Subject's PT, aPTT, and TT are within the normal laboratory range
Subject is a nonsmoker

Exclusion Criteria

Subject has a current or recent history of regular alcohol consumption
Subjects who are enrolled in Part B and allergic to acetylsalicylic acid, other salicylates, clopidogrel, thienopyridines (eg, ticlopidine, prasugrel), apixaban or dabigatran
Part B Cohort 2 only: subjects who are poor metabolizers of clopidogrel (CYP2C19 _2/_ 2, _2/_ 3, or _3/_ 3 genotype)
Subject has a presence or history of coagulation abnormality
Subjects need to receive a surgery or clinical procedures associated with high bleeding risk
Subject has a history of minor bleeding episodes, eg, epistaxis, rectal bleeding, gingival bleeding
Subject has a history of peptic ulcer or gastrointestinal bleeding
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