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First human tests begin for new drug DW4421

NCT ID NCT07691242

Knowledge-focused Sponsor: Daewon Pharmaceutical 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This early-stage trial evaluates the safety of multiple doses of an investigational drug called DW4421 in healthy adults aged 19 to 50. Researchers will measure how the drug moves through the body and how it is processed. The study aims to gather essential safety and dosing information before testing in patients.

What this could mean

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

Active substance
DW4421
What this could lead to
If safe, this could pave the way for future studies of DW4421 as a potential treatment.
What could go wrong
This is an early phase 1 trial in a small number of healthy people, so it cannot prove effectiveness and may reveal unexpected side effects.
Why investors are watching

Daewon Pharmaceutical is running a phase 1 trial of DW4421, a drug given multiple times to healthy volunteers, to test its safety and how the body processes it. For a small publicly traded company, this early readout matters because it is the first signal of whether the drug is safe enough to keep developing, and a clear result can shape the company's pipeline value.

If it works: If the trial shows DW4421 is safe and well tolerated, Daewon can move the drug into later-stage testing, which may strengthen its development pipeline. A positive safety readout could also draw more attention from partners or investors.

If it fails: Phase 1 trials often fail because the drug causes unexpected side effects or behaves poorly in the body. If DW4421 fails or the trial is delayed, Daewon may have to pause or abandon this program, which could hurt its pipeline and share price.

AI-written from the trial record. Speculative, and not investment advice.

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

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

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

19 to 50 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 adult aged 19 to 50 (inclusive) years, at the time of screening. * Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit. Exclusion Criteria: * Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history.

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As listed by the trial registrant

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

Healthy adult volunteers

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, South Korea

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