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Completed

NCT Number: NCT04809818

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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lumosa Phase 1 Unit

Cypress, California, 90630, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LT3001 Drug Product

Drug

Multiple doses of LT3001 drug product administered by intravenous infusion

Other names: LT3001 injection

Placebo

Drug

Multiple doses of Placebo administered by intravenous infusion

Other names: Placebo of LT3001 drug product

Aspirin

Drug

Loading and maintenance doses of Aspirin administered by oral

Other names: Aspirin tablet

clopidogrel

Drug

Loading and maintenance doses of Clopidogrel administered by oral

Other names: Clopidogrel tablet

Apixaban

Drug

Multiple doses of Apixaban administered by oral

Other names: Eliquis®

dabigatran

Drug

Multiple doses of Dabigatran administered by oral

Other names: Pradaxa®

Primary outcomes

  1. Number of Adverse Events

    Time frame: Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.

    To evaluate the safety and tolerability of LT3001 administered alone or in combination with aspirin, clopidogrel, apixaban, or dabigatran, as determined by the number and severity of adverse events collected from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.

Secondary outcomes

  1. Change From Baseline in Activated Partial Thromboplastin Time (APTT)

    Time frame: 16 days

    Change from baseline in activated partial thromboplastin time (APTT), measured in seconds, was assessed to evaluate the safety of LT3001 administered alone or in combination with aspirin, clopidogrel, apixaban, or dabigatran from baseline up to 16 days post-dose.

  2. Number of Participants With Prolongation in Platelet Function Test

    Time frame: 16 days

    The outcome measured the number of participants with prolongation in platelet function test results following administration of LT3001 alone or in combination with aspirin, clopidogrel, apixaban, or dabigatran.

    Platelet function was assessed using collagen/epinephrine and collagen/ADP assays. Results were evaluated from baseline up to 16 days post-dose.

    Participants in the Part A placebo group did not undergo platelet function testing and were therefore not included in this outcome analysis.

  3. Plasma PK Parameters of LT3001 - Cmax

    Time frame: Predose and post-dose time points up to 10 days after dosing

    Plasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.

  4. Plasma PK Parameters of LT3001 - Tmax

    Time frame: 10 days

    Plasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.

  5. Plasma PK Parameters of LT3001 - AUC

    Time frame: 10 days

    Plasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.

  6. Plasma PK Parameters of Aspirin - Cmax

    Time frame: 8 days

    Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin were administered.

  7. Plasma PK Parameters of Aspirin - Tmax

    Time frame: 8 days

    Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin were administered.

  8. Plasma PK Parameters of Aspirin - AUC

    Time frame: 8 days

    Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin were administered.

  9. Plasma PK Parameters of Clopidogrel - Cmax

    Time frame: 10 days

    Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel were administered.

  10. Plasma PK Parameters of Clopidogrel - Tmax

    Time frame: 10 days

    Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel administered (alone or with LT3001).

  11. Plasma PK Parameters of Clopidogrel - AUC

    Time frame: 10 days

    Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel were administered.

  12. Plasma PK Parameters of Apixaban - Cmax

    Time frame: 8 days

    Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban were administered.

  13. Plasma PK Parameters of Apixaban - Tmax

    Time frame: 8 days

    Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban were administered.

  14. Plasma PK Parameters of Apixaban - AUC

    Time frame: 8 days

    Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban were administered.

  15. Plasma PK Parameters of Dabigatran - Cmax

    Time frame: 8 days

    Plasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran were administered.

  16. Plasma PK Parameters of Dabigatran - Tmax

    Time frame: 8 days

    Plasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran administered (alone or with LT3001).

  17. Plasma PK Parameters of Dabigatran - AUC

    Time frame: 8 days

    Plasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran administered (alone or with LT3001).

Sponsors and collaborators

Lead sponsor

Lumosa Therapeutics Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2021
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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