Acute Ischemic Stroke
Conditions
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.
Interventions
Multiple doses of LT3001 drug product administered by intravenous infusion
DRUGPlacebo
Multiple doses of Placebo administered by intravenous infusion
DRUGAspirin
Loading and maintenance doses of Aspirin administered by oral
DRUGClopidogrel
Loading and maintenance doses of Clopidogrel administered by oral
DRUGApixaban
Multiple doses of Apixaban administered by oral
DRUGDabigatran
Multiple doses of Dabigatran administered by oral
Sponsors
Lumosa Therapeutics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Part A: parallel Part B: single group
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Activated Partial Thromboplastin Time (APTT) | 16 days | Change from baseline in activated partial thromboplastin time (APTT), measured in seconds, was assessed to evaluate the safety of LT3001 administered alone or in combination with aspirin, clopidogrel, apixaban, or dabigatran from baseline up to 16 days post-dose. |
| Number of Participants With Prolongation in Platelet Function Test | 16 days | The outcome measured the number of participants with prolongation in platelet function test results following administration of LT3001 alone or in combination with aspirin, clopidogrel, apixaban, or dabigatran. Platelet function was assessed using collagen/epinephrine and collagen/ADP assays. Results were evaluated from baseline up to 16 days post-dose. Participants in the Part A placebo group did not undergo platelet function testing and were therefore not included in this outcome analysis. |
| Plasma PK Parameters of LT3001 - Cmax | Predose and post-dose time points up to 10 days after dosing | 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 were administered. |
| 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 were administered. |
| 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 were administered. |
| 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 were administered. |
| 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 Clopidogrel - AUC | 10 days | Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel were administered. |
| 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 were administered. |
| 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 were administered. |
| 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 were administered. |
| 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 were administered. |
| 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). |
Countries
United States
Contacts
STUDY_DIRECTORMimi Yeh, PhD
Lumosa Phase 1 unit
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants |
| Age, Continuous | 42 year |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 4 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 3 / 12 | 0 / 4 | 2 / 12 | 2 / 12 | 2 / 12 | 1 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 4 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
None listed