Acute Ischemic StrokePhase 1NCT04809818
A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects
A Phase 1 study testing LT3001 drug product, Aspirin and Clopidogrel in people with Acute Ischemic Stroke, run by Lumosa Therapeutics Co., Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- LT3001 drug product, Aspirin and Clopidogrel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2021to 5 Aug 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- LT3001 drug product, Placebo, Aspirin, Clopidogrel, Apixaban
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LT3001 drug productDrug
Also called LT3001 injection
Multiple doses of LT3001 drug product administered by intravenous infusion
PlaceboDrug
Also called Placebo of LT3001 drug product
Multiple doses of Placebo administered by intravenous infusion
AspirinDrug
Also called Aspirin tablet
Loading and maintenance doses of Aspirin administered by oral
ClopidogrelDrug
Also called Clopidogrel tablet
Loading and maintenance doses of Clopidogrel administered by oral
ApixabanDrug
Also called Eliquis®
Multiple doses of Apixaban administered by oral
DabigatranDrug
Also called Pradaxa®
Multiple doses of Dabigatran administered by oral
| Study group | Role | What they receive |
|---|---|---|
| Part A - LT3001 Drug Product | Experimental | Multiple doses of LT3001 administered by intravenous infusion Receives: Drug: LT3001 drug product |
| Part A - Placebo | Placebo comparator | Multiple doses of Placebo administered by intravenous infusion Receives: Drug: Placebo |
| Part B - LT3001 and Aspirin | Experimental | Multiple doses of LT3001 and Aspirin administered Receives: Drug: LT3001 drug product; Drug: Aspirin |
| Part B - LT3001 and Clopidogrel | Experimental | Multiple doses of LT3001 and Clopidogrel administered Receives: Drug: LT3001 drug product; Drug: Clopidogrel |
| Part B - LT3001 and Apixaban | Experimental | Multiple doses of LT3001 and Apixaban administered Receives: Drug: LT3001 drug product; Drug: Apixaban |
| Part B - LT3001 and Dabigatran | Experimental | Multiple doses of LT3001 and Dabigatran administered Receives: Drug: LT3001 drug product; Drug: Dabigatran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
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.
Measured: 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.
Secondary outcomes (17)
Change From Baseline in Activated Partial Thromboplastin Time (APTT)
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.
Measured: 16 days
Number of Participants With Prolongation in Platelet Function Test
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.
Measured: 16 days
Plasma PK Parameters of LT3001 - Cmax
Plasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.
Measured: Predose and post-dose time points up to 10 days after dosing
Plasma PK Parameters of LT3001 - Tmax
Plasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.
Measured: 10 days
Plasma PK Parameters of LT3001 - AUC
Plasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.
Measured: 10 days
Plasma PK Parameters of Aspirin - Cmax
Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin were administered.
Measured: 8 days
Plasma PK Parameters of Aspirin - Tmax
Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin were administered.
Measured: 8 days
Plasma PK Parameters of Aspirin - AUC
Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin were administered.
Measured: 8 days
Plasma PK Parameters of Clopidogrel - Cmax
Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel were administered.
Measured: 10 days
Plasma PK Parameters of Clopidogrel - Tmax
Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel administered (alone or with LT3001).
Measured: 10 days
Plasma PK Parameters of Clopidogrel - AUC
Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel were administered.
Measured: 10 days
Plasma PK Parameters of Apixaban - Cmax
Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban were administered.
Measured: 8 days
Plasma PK Parameters of Apixaban - Tmax
Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban were administered.
Measured: 8 days
Plasma PK Parameters of Apixaban - AUC
Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban were administered.
Measured: 8 days
Plasma PK Parameters of Dabigatran - Cmax
Plasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran were administered.
Measured: 8 days
Plasma PK Parameters of Dabigatran - Tmax
Plasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran administered (alone or with LT3001).
Measured: 8 days
Plasma PK Parameters of Dabigatran - AUC
Plasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran administered (alone or with LT3001).
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start21 Mar 2021
- Primary completion5 Aug 2021
- Study completion5 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part A: parallel Part B: single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumosa Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mimi Yeh, PhD, Study director, Lumosa Phase 1 unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809818
- Sponsor's protocol ID
- LT3001-105
- Status last verified
- Feb 2026
- First submitted
- 5 Mar 2021
- Last updated
- 2 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04809818
- Acronym / sponsor ID
- LT3001-105
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Lumosa Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2021 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Posted 6 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Part A: parallel Part B: single group
| Arm | Type | Receives |
|---|---|---|
| Part A - LT3001 Drug Product | Experimental | Drug: LT3001 drug productMultiple doses of LT3001 administered by intravenous infusion |
| Part A - Placebo | Placebo comparator | Drug: PlaceboMultiple doses of Placebo administered by intravenous infusion |
| Part B - LT3001 and Aspirin | Experimental | Drug: LT3001 drug product, Drug: AspirinMultiple doses of LT3001 and Aspirin administered |
| Part B - LT3001 and Clopidogrel | Experimental | Drug: LT3001 drug product, Drug: ClopidogrelMultiple doses of LT3001 and Clopidogrel administered |
| Part B - LT3001 and Apixaban | Experimental | Drug: LT3001 drug product, Drug: ApixabanMultiple doses of LT3001 and Apixaban administered |
| Part B - LT3001 and Dabigatran | Experimental | Drug: LT3001 drug product, Drug: DabigatranMultiple doses of LT3001 and Dabigatran administered |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LT3001 drug productAlso: LT3001 injectionMultiple doses of LT3001 drug product administered by intravenous infusion | Drug | Part A - LT3001 Drug Product, Part B - LT3001 and Apixaban, Part B - LT3001 and Aspirin, Part B - LT3001 and Clopidogrel, Part B - LT3001 and Dabigatran |
| PlaceboAlso: Placebo of LT3001 drug productMultiple doses of Placebo administered by intravenous infusion | Drug | Part A - Placebo |
| AspirinAlso: Aspirin tabletLoading and maintenance doses of Aspirin administered by oral | Drug | Part B - LT3001 and Aspirin |
| ClopidogrelAlso: Clopidogrel tabletLoading and maintenance doses of Clopidogrel administered by oral | Drug | Part B - LT3001 and Clopidogrel |
| ApixabanAlso: Eliquis®Multiple doses of Apixaban administered by oral | Drug | Part B - LT3001 and Apixaban |
| DabigatranAlso: Pradaxa®Multiple doses of Dabigatran administered by oral | Drug | Part B - LT3001 and Dabigatran |
Primary outcome
Number of Adverse Events
Time frame: 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.
17 secondary outcomes
Change From Baseline in Activated Partial Thromboplastin Time (APTT)
Time frame: 16 days
Number of Participants With Prolongation in Platelet Function Test
Time frame: 16 days
Plasma PK Parameters of LT3001 - Cmax
Time frame: Predose and post-dose time points up to 10 days after dosing
Plasma PK Parameters of LT3001 - Tmax
Time frame: 10 days
Plasma PK Parameters of LT3001 - AUC
Time frame: 10 days
Plasma PK Parameters of Aspirin - Cmax
Time frame: 8 days
Plasma PK Parameters of Aspirin - Tmax
Time frame: 8 days
Plasma PK Parameters of Aspirin - AUC
Time frame: 8 days
Plasma PK Parameters of Clopidogrel - Cmax
Time frame: 10 days
Plasma PK Parameters of Clopidogrel - Tmax
Time frame: 10 days
Plasma PK Parameters of Clopidogrel - AUC
Time frame: 10 days
Plasma PK Parameters of Apixaban - Cmax
Time frame: 8 days
Plasma PK Parameters of Apixaban - Tmax
Time frame: 8 days
Plasma PK Parameters of Apixaban - AUC
Time frame: 8 days
Plasma PK Parameters of Dabigatran - Cmax
Time frame: 8 days
Plasma PK Parameters of Dabigatran - Tmax
Time frame: 8 days
Plasma PK Parameters of Dabigatran - AUC
Time frame: 8 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mimi Yeh, PhD study director
Lumosa Phase 1 unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LT3001 drug product, Aspirin and Clopidogrel in people with Acute Ischemic Stroke, run by Lumosa Therapeutics Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.