A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects
- Conditions
- Acute Ischemic Stroke
- Interventions
- Registration Number
- NCT04809818
- Lead Sponsor
- Lumosa Therapeutics Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 64
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A - LT3001 Drug Product LT3001 drug product Multiple doses of LT3001 administered by intravenous infusion Part A - Placebo Placebo Multiple doses of Placebo administered by intravenous infusion Part B - LT3001 and Aspirin LT3001 drug product Multiple doses of LT3001 and Aspirin administered Part B - LT3001 and Clopidogrel LT3001 drug product Multiple doses of LT3001 and Clopidogrel administered Part B - LT3001 and Apixaban LT3001 drug product Multiple doses of LT3001 and Apixaban administered Part B - LT3001 and Dabigatran LT3001 drug product Multiple doses of LT3001 and Dabigatran administered Part B - LT3001 and Dabigatran Dabigatran Multiple doses of LT3001 and Dabigatran administered Part B - LT3001 and Aspirin Aspirin Multiple doses of LT3001 and Aspirin administered Part B - LT3001 and Clopidogrel Clopidogrel Multiple doses of LT3001 and Clopidogrel administered Part B - LT3001 and Apixaban Apixaban Multiple doses of LT3001 and Apixaban administered
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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).
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.
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 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 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).
Trial Locations
- Locations (1)
Lumosa Phase 1 Unit
🇺🇸Cypress, California, United States