Status:
COMPLETED
A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects
Lead Sponsor:
Lumosa Therapeutics Co., Ltd.
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 concom...
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-lab...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2021
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04809818
Start Date
March 21 2021
End Date
August 5 2021
Last Update
December 10 2025
Active Locations (1)
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1
Lumosa Phase 1 Unit
Cypress, California, United States, 90630