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

Sponsor

Lumosa Therapeutics Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04809818

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

9.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Drug: LT3001 drug product Drug: Placebo Drug: Aspirin Drug: Clopidogrel Drug: Apixaban Drug: Dabigatran	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Part A: parallel Part B: single groupPart A: parallel Part B: single group

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Mar 21, 2021

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Oct 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A - LT3001 Drug Product Multiple doses of LT3001 administered by intravenous infusion	Drug: LT3001 drug product Multiple doses of LT3001 drug product administered by intravenous infusion Other Names: LT3001 injection
Placebo Comparator: Part A - Placebo Multiple doses of Placebo administered by intravenous infusion	Drug: Placebo Multiple doses of Placebo administered by intravenous infusion Other Names: Placebo of LT3001 drug product
Experimental: Part B - LT3001 and Aspirin Multiple doses of LT3001 and Aspirin administered	Drug: LT3001 drug product Multiple doses of LT3001 drug product administered by intravenous infusion Other Names: LT3001 injection Drug: Aspirin Loading and maintenance doses of Aspirin administered by oral Other Names: Aspirin tablet
Experimental: Part B - LT3001 and Clopidogrel Multiple doses of LT3001 and Clopidogrel administered	Drug: LT3001 drug product Multiple doses of LT3001 drug product administered by intravenous infusion Other Names: LT3001 injection Drug: Clopidogrel Loading and maintenance doses of Clopidogrel administered by oral Other Names: Clopidogrel tablet
Experimental: Part B - LT3001 and Apixaban Multiple doses of LT3001 and Apixaban administered	Drug: LT3001 drug product Multiple doses of LT3001 drug product administered by intravenous infusion Other Names: LT3001 injection Drug: Apixaban Multiple doses of Apixaban administered by oral Other Names: Eliquis®
Experimental: Part B - LT3001 and Dabigatran Multiple doses of LT3001 and Dabigatran administered	Drug: LT3001 drug product Multiple doses of LT3001 drug product administered by intravenous infusion Other Names: LT3001 injection Drug: Dabigatran Multiple doses of Dabigatran administered by oral Other Names: Pradaxa®

Outcome Measures

Primary Outcome Measures

Number of adverse events [16 days]
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 [16 days]
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 [16 days]
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 [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.
Plasma PK parameters of LT3001 - Tmax [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.
Plasma PK parameters of LT3001 - AUC [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.
Plasma PK parameters of Aspirin - Cmax [8 days]
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 [8 days]
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 [8 days]
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 [10 days]
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 [10 days]
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 [10 days]
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 [8 days]
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 [8 days]
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 [8 days]
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 [8 days]
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 [8 days]
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 [8 days]
Plasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran administered (alone or with LT3001).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lumosa Phase 1 Unit	Cypress	California	United States	90630

Sponsors and Collaborators

Lumosa Therapeutics Co., Ltd.

Investigators

Study Director: Mimi Yeh, PhD, Lumosa Phase 1 unit

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lumosa Therapeutics Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04809818

Other Study ID Numbers:

LT3001-105

First Posted:

Mar 22, 2021

Last Update Posted:

Mar 22, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2021