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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: LT3001 drug product; Drug: Placebo; Drug: Aspirin; Drug: Clopidogrel; Drug: Apixaban; Drug: Dabigatran

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 Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kevin Hsiao; Phone Number: 5707 +886226557918; Email: kevin_hsiao@lumosa.com.tw

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • Recruiting
      • Lumosa Phase 1 Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 days
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.	16 days
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.	10 days
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.	10 days
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.	10 days
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).	8 days
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).	8 days
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).	8 days
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).	10 days
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).	10 days
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).	10 days
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).	8 days
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).	8 days
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).	8 days
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).	8 days
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).	8 days
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).	8 days

Collaborators and Investigators

• Sponsor: Lumosa Therapeutics Co., Ltd.
• Investigators: Study Director: Mimi Yeh, PhD, Lumosa Phase 1 Unit

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 21, 2021
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): October 19, 2021

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (ACTUAL): March 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Aspirin; Clopidogrel; Dabigatran; Apixaban
• Other Study ID Numbers: LT3001-105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No