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

NCT04809818 | Completed Phase 1 Results FDA Drug

• 1 other identifier: LT3001-105
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  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.

  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.

Secondary Outcomes (17)

• Change From Baseline in Activated Partial Thromboplastin Time (APTT)

  16 days

• Number of Participants With Prolongation in Platelet Function Test

  16 days

• Plasma PK Parameters of LT3001 - Cmax

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

• Plasma PK Parameters of LT3001 - Tmax

  10 days

• Plasma PK Parameters of LT3001 - AUC

  10 days

Study Arms (6)

Part A - LT3001 Drug Product

EXPERIMENTAL

Multiple doses of LT3001 administered by intravenous infusion

Drug: LT3001 drug product

Part A - Placebo

PLACEBO COMPARATOR

Multiple doses of Placebo administered by intravenous infusion

Drug: Placebo

Part B - LT3001 and Aspirin

EXPERIMENTAL

Multiple doses of LT3001 and Aspirin administered

Drug: LT3001 drug product; Drug: Aspirin

Part B - LT3001 and Clopidogrel

EXPERIMENTAL

Multiple doses of LT3001 and Clopidogrel administered

Drug: LT3001 drug product; Drug: Clopidogrel

Part B - LT3001 and Apixaban

EXPERIMENTAL

Multiple doses of LT3001 and Apixaban administered

Drug: LT3001 drug product; Drug: Apixaban

Part B - LT3001 and Dabigatran

EXPERIMENTAL

Multiple doses of LT3001 and Dabigatran administered

Drug: LT3001 drug product; Drug: Dabigatran

Interventions

LT3001 drug product DRUG

Multiple doses of LT3001 drug product administered by intravenous infusion

Also known as: LT3001 injection

Part A - LT3001 Drug Product; Part B - LT3001 and Apixaban; Part B - LT3001 and Aspirin; Part B - LT3001 and Clopidogrel; Part B - LT3001 and Dabigatran

Placebo DRUG

Multiple doses of Placebo administered by intravenous infusion

Also known as: Placebo of LT3001 drug product

Part A - Placebo

Aspirin DRUG

Loading and maintenance doses of Aspirin administered by oral

Also known as: Aspirin tablet

Part B - LT3001 and Aspirin

Clopidogrel DRUG

Loading and maintenance doses of Clopidogrel administered by oral

Also known as: Clopidogrel tablet

Part B - LT3001 and Clopidogrel

Apixaban DRUG

Multiple doses of Apixaban administered by oral

Also known as: Eliquis®

Part B - LT3001 and Apixaban

Dabigatran DRUG

Multiple doses of Dabigatran administered by oral

Also known as: Pradaxa®

Part B - LT3001 and Dabigatran

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lumosa Therapeutics Co., Ltd.: lead

Study Sites (1)

Lumosa Phase 1 Unit

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Aspirin; Clopidogrel; apixaban; Dabigatran

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzimidazoles

Results Point of Contact

• Title: Contact of Clinical Trials
• Organization: Lumosa

kevin_hsiao@lumosa.com.tw

886-2-26557918

Study Officials

• Mimi Yeh, PhD

  Lumosa Phase 1 unit

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A: parallel Part B: single group

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 22, 2021
• Study Start: March 21, 2021
• Primary Completion: August 5, 2021
• Study Completion: August 5, 2021
• Last Updated: March 2, 2026
• Results First Posted: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)