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.

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.

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.