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

Lumosa Therapeutics

Status and phase: Completed; Phase 1

Conditions: Acute Ischemic Stroke

Treatments: Drug: LT3001 drug product; Drug: Apixaban; Drug: Clopidogrel; Drug: Aspirin; Drug: Placebo; Drug: Dabigatran

Study type: Interventional

Funder types: Industry

Identifiers

NCT04809818

LT3001-105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 6 patient groups, including a placebo group

Part A - LT3001 Drug Product

Experimental group

Description:

Multiple doses of LT3001 administered by intravenous infusion

Treatment:

Drug: LT3001 drug product

Part A - Placebo

Placebo Comparator group

Description:

Multiple doses of Placebo administered by intravenous infusion

Treatment:

Drug: Placebo

Part B - LT3001 and Aspirin

Experimental group

Description:

Multiple doses of LT3001 and Aspirin administered

Treatment:

Drug: Aspirin

Drug: LT3001 drug product

Part B - LT3001 and Clopidogrel

Experimental group

Description:

Multiple doses of LT3001 and Clopidogrel administered

Treatment:

Drug: Clopidogrel

Drug: LT3001 drug product

Part B - LT3001 and Apixaban

Experimental group

Description:

Multiple doses of LT3001 and Apixaban administered

Treatment:

Drug: Apixaban

Drug: LT3001 drug product

Part B - LT3001 and Dabigatran

Experimental group

Description:

Multiple doses of LT3001 and Dabigatran administered

Treatment:

Drug: Dabigatran

Drug: LT3001 drug product