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New prostate drug candidate put to the test in healthy volunteers

NCT ID NCT07643233

Disease control Sponsor: AJU Pharm 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial will compare a new drug called AJU-G721 to an existing reference drug, G721R, in 36 healthy adult men. The goal is to see if the two drugs produce similar levels in the blood and have comparable safety. Both drugs contain tamsulosin, which is used to treat symptoms of an enlarged prostate.

What this could mean

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

Active substance
Tamsulosin (in AJU-G721 and G721R)
What this could lead to
If successful, this could confirm that AJU-G721 works the same as the reference drug, potentially offering a new treatment option for enlarged prostate.
What could go wrong
This is an early Phase 1 study in only 36 healthy men, not patients. It only checks drug levels and safety, not whether it actually helps BPH symptoms.

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 36 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Aug 2026

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 54 years

Sex

Male participants only

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 adults aged ≥19 years and \<55 years at screening. * Body weight ≥ 50 kg and body mass index (BMI) between 18 and 30 kg/m². * Clinically healthy based on medical history, physical examination, ECG, and laboratory test results, as determined by the investigator. * Willing and able to provide written informed consent. * Agrees to use medically acceptable contraception during the required study period. Exclusion Criteria: * Use of medications known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or other medications that may interfere with the study within 10 days prior to dosing. * Participation in another clinical trial involving an investigational product within 6 months prior to the first dose. * Whole blood donation within 8 weeks or component blood donation within 2 weeks prior to the first dose. * History of gastrointestinal resection that may affect drug absorption. * Known hypersensitivity to dutasteride, tamsulosin, or any component of the investigational product. * History of psychiatric illness, or any condition considered unsuitable for study participation by the investigator.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia

As listed by the trial registrant

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

Moderate-to-severe benign prostatic hyperplasia (BPH)

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Bumin Hospital

    Seoul, South Korea

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