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New drug LW402 takes first step: safety check in 36 volunteers

NCT ID NCT07546149

Knowledge-focused Sponsor: Shanghai Longwood Biopharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tested the safety and tolerability of LW402 tablets in 36 healthy volunteers. Participants received either the drug or a placebo, and researchers monitored for side effects and how the drug moves through the body. Since this is a Phase 1 study, the main goal is to see if the drug is safe enough to test in larger trials.

What this could mean

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

Active substance
LW402 tablets
What this could lead to
If successful, this could pave the way for future studies of LW402 as a potential treatment for an unspecified condition.
What could go wrong
This is a very early Phase 1 trial with only 36 healthy volunteers, so it cannot prove the drug works for any disease. Side effects or lack of tolerability may stop further development.

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

36 people

The number who actually took part.

Started

Oct 2025

Finished

Dec 2025

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 55 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: * Healthy male and female subjects of non-child bearing potential as determined by medical history, physical exam and vial sign measurements * Body Mass Index of 18-26 kg/m2 inclusive with body weight males ≥ 50 kg, females ≥ 45 kg Exclusion Criteria: * Clinically significant disease that requires a physician's care and/or would interfere with study evaluations * History of drug or alcohol abuse, consumption of alcohol within 48 hours prior to randomization, or a positive test for alcohol or drugs with a high potential for abuse prior to randomization * Other exclusion criteria apply

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As listed by the trial registrant

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

Safety evaluation of escalating doses

Contacts and locations

Locations

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shangdong, China

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