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New stroke drug LT3001 passes first safety check in healthy volunteers

NCT ID NCT04809818

Knowledge-focused Sponsor: Lumosa Therapeutics Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 1 trial tested the safety of LT3001, a potential clot-busting drug for acute ischemic stroke, in 65 healthy adults. Participants received multiple doses of LT3001 alone or with common stroke medications like aspirin and clopidogrel. The goal was to check for side effects and how the drug interacts with other treatments, not to measure effectiveness against stroke.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LT3001 injection
What this could lead to
If successful, this could pave the way for a new stroke treatment that dissolves clots and may be safer when used with other medications.
What could go wrong
This is an early Phase 1 study in healthy volunteers, not stroke patients. It only tests safety and drug interactions, not whether LT3001 actually treats strokes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

65 people

The number who actually took part.

Started

Mar 2021

Finished

Aug 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke

Contacts and locations

Locations

  • Lumosa Phase 1 Unit

    Cypress, California, 90630, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.