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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

Primary Purpose

Acute Ischemic Stroke

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LT3001 drug product
Placebo
Aspirin
Clopidogrel
Apixaban
Dabigatran
Sponsored by
Lumosa Therapeutics Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Lumosa Phase 1 UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Part A - LT3001 Drug Product

Part A - Placebo

Part B - LT3001 and Aspirin

Part B - LT3001 and Clopidogrel

Part B - LT3001 and Apixaban

Part B - LT3001 and Dabigatran

Arm Description

Multiple doses of LT3001 administered by intravenous infusion

Multiple doses of Placebo administered by intravenous infusion

Multiple doses of LT3001 and Aspirin administered

Multiple doses of LT3001 and Clopidogrel administered

Multiple doses of LT3001 and Apixaban administered

Multiple doses of LT3001 and Dabigatran administered

Outcomes

Primary Outcome Measures

Number of adverse events
To evaluate the safety and tolerability of LT3001 administered alone or with Aspirin, Clopidogrel, Apixaban, Dabigatran determined by number and severity of adverse events from the time of dosing up to 16 days post-dose.

Secondary Outcome Measures

Changes from baseline in coagulation
To evaluate the safety of LT3001 administered alone or with Aspirin, Clopidogrel, Apixaban, Dabigatran determined by coagulation test from baseline up to 16 days post-dose.
Changes from baseline in platelet function test
To evaluate the safety of LT3001 administered alone or with Aspirin, Clopidogrel, Apixaban, Dabigatran determined by platelet function from baseline up to 16 days post-dose.
Plasma PK parameters of LT3001 - Cmax
Plasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.
Plasma PK parameters of LT3001 - Tmax
Plasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.
Plasma PK parameters of LT3001 - AUC
Plasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.
Plasma PK parameters of Aspirin - Cmax
Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin administered (alone or with LT3001).
Plasma PK parameters of Aspirin - Tmax
Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin administered (alone or with LT3001).
Plasma PK parameters of Aspirin - AUC
Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin administered (alone or with LT3001).
Plasma PK parameters of Clopidogrel - Cmax
Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel administered (alone or with LT3001).
Plasma PK parameters of Clopidogrel - Tmax
Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel administered (alone or with LT3001).
Plasma PK parameters of Clopidogrel - AUC
Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel administered (alone or with LT3001).
Plasma PK parameters of Apixaban - Cmax
Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban administered (alone or with LT3001).
Plasma PK parameters of Apixaban - Tmax
Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban administered (alone or with LT3001).
Plasma PK parameters of Apixaban - AUC
Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban administered (alone or with LT3001).
Plasma PK parameters of Dabigatran - Cmax
Plasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran administered (alone or with LT3001).
Plasma PK parameters of Dabigatran - Tmax
Plasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran administered (alone or with LT3001).
Plasma PK parameters of Dabigatran - AUC
Plasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran administered (alone or with LT3001).

Full Information

First Posted
March 5, 2021
Last Updated
March 17, 2021
Sponsor
Lumosa Therapeutics Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04809818
Brief Title
A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 21, 2021 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
October 19, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumosa Therapeutics Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Part A: parallel Part B: single group
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A - LT3001 Drug Product
Arm Type
Experimental
Arm Description
Multiple doses of LT3001 administered by intravenous infusion
Arm Title
Part A - Placebo
Arm Type
Placebo Comparator
Arm Description
Multiple doses of Placebo administered by intravenous infusion
Arm Title
Part B - LT3001 and Aspirin
Arm Type
Experimental
Arm Description
Multiple doses of LT3001 and Aspirin administered
Arm Title
Part B - LT3001 and Clopidogrel
Arm Type
Experimental
Arm Description
Multiple doses of LT3001 and Clopidogrel administered
Arm Title
Part B - LT3001 and Apixaban
Arm Type
Experimental
Arm Description
Multiple doses of LT3001 and Apixaban administered
Arm Title
Part B - LT3001 and Dabigatran
Arm Type
Experimental
Arm Description
Multiple doses of LT3001 and Dabigatran administered
Intervention Type
Drug
Intervention Name(s)
LT3001 drug product
Other Intervention Name(s)
LT3001 injection
Intervention Description
Multiple doses of LT3001 drug product administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo of LT3001 drug product
Intervention Description
Multiple doses of Placebo administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Aspirin tablet
Intervention Description
Loading and maintenance doses of Aspirin administered by oral
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Clopidogrel tablet
Intervention Description
Loading and maintenance doses of Clopidogrel administered by oral
Intervention Type
Drug
Intervention Name(s)
Apixaban
Other Intervention Name(s)
Eliquis®
Intervention Description
Multiple doses of Apixaban administered by oral
Intervention Type
Drug
Intervention Name(s)
Dabigatran
Other Intervention Name(s)
Pradaxa®
Intervention Description
Multiple doses of Dabigatran administered by oral
Primary Outcome Measure Information:
Title
Number of adverse events
Description
To evaluate the safety and tolerability of LT3001 administered alone or with Aspirin, Clopidogrel, Apixaban, Dabigatran determined by number and severity of adverse events from the time of dosing up to 16 days post-dose.
Time Frame
16 days
Secondary Outcome Measure Information:
Title
Changes from baseline in coagulation
Description
To evaluate the safety of LT3001 administered alone or with Aspirin, Clopidogrel, Apixaban, Dabigatran determined by coagulation test from baseline up to 16 days post-dose.
Time Frame
16 days
Title
Changes from baseline in platelet function test
Description
To evaluate the safety of LT3001 administered alone or with Aspirin, Clopidogrel, Apixaban, Dabigatran determined by platelet function from baseline up to 16 days post-dose.
Time Frame
16 days
Title
Plasma PK parameters of LT3001 - Cmax
Description
Plasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.
Time Frame
10 days
Title
Plasma PK parameters of LT3001 - Tmax
Description
Plasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.
Time Frame
10 days
Title
Plasma PK parameters of LT3001 - AUC
Description
Plasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.
Time Frame
10 days
Title
Plasma PK parameters of Aspirin - Cmax
Description
Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin administered (alone or with LT3001).
Time Frame
8 days
Title
Plasma PK parameters of Aspirin - Tmax
Description
Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin administered (alone or with LT3001).
Time Frame
8 days
Title
Plasma PK parameters of Aspirin - AUC
Description
Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin administered (alone or with LT3001).
Time Frame
8 days
Title
Plasma PK parameters of Clopidogrel - Cmax
Description
Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel administered (alone or with LT3001).
Time Frame
10 days
Title
Plasma PK parameters of Clopidogrel - Tmax
Description
Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel administered (alone or with LT3001).
Time Frame
10 days
Title
Plasma PK parameters of Clopidogrel - AUC
Description
Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel administered (alone or with LT3001).
Time Frame
10 days
Title
Plasma PK parameters of Apixaban - Cmax
Description
Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban administered (alone or with LT3001).
Time Frame
8 days
Title
Plasma PK parameters of Apixaban - Tmax
Description
Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban administered (alone or with LT3001).
Time Frame
8 days
Title
Plasma PK parameters of Apixaban - AUC
Description
Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban administered (alone or with LT3001).
Time Frame
8 days
Title
Plasma PK parameters of Dabigatran - Cmax
Description
Plasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran administered (alone or with LT3001).
Time Frame
8 days
Title
Plasma PK parameters of Dabigatran - Tmax
Description
Plasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran administered (alone or with LT3001).
Time Frame
8 days
Title
Plasma PK parameters of Dabigatran - AUC
Description
Plasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran administered (alone or with LT3001).
Time Frame
8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Hsiao
Phone
+886226557918
Ext
5707
Email
kevin_hsiao@lumosa.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mimi Yeh, PhD
Organizational Affiliation
Lumosa Phase 1 unit
Official's Role
Study Director
Facility Information:
Facility Name
Lumosa Phase 1 Unit
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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