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New drug GEn-1124 tested in just 6 men – first look at how body handles it

NCT ID NCT07185113

Knowledge-focused Sponsor: GEn1E Lifesciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase study tested a single oral dose of GEn-1124 in 6 healthy adult men. Researchers measured how the drug moves through the body and checked for any side effects. Participants stayed in the clinic for 2 days and received follow-up phone calls. The goal was to gather basic safety and processing information, not to treat any disease.

What this could mean

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

Active substance
GEn-1124 (oral capsule)
What could go wrong
This is a very early, small study in just 6 healthy men. It only looks at how the drug moves through the body and basic safety, not whether it treats any disease. Many early-stage drugs never advance.

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

6 people

The number who actually took part.

Started

Oct 2025

Finished

Nov 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

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: 1. Healthy male subjects; 2. Between 18 and 55 years of age; 3. Provide a signed EC-approved consent form; 4. Generally healthy, in the opinion of the Investigator; 5. Body Mass Index (BMI) 18 to 32 kg/m\^2; 6. Creatinine clearance with in specific parameter; 7. Using method of contraception; 8. Willing and able to comply with protocol requirements for the duration of the study. Exclusion Criteria: 1. Subjects taking prohibited medication; 2. Subjects with a history or presence of clinically significant medical or psychiatric disease; 3. Subjects who have regularly used nicotine-containing products ; 4. Subjects who have used caffeine-containing products; 5. Subjects who are unable to comply with eating a standardized meal during the study; 6. Subjects with a hospital admission or major surgery within 30 days prior to Screening; 7. Subjects with a plasma donation within 7 days prior to Screening; 8. Subjects who have not abstained from alcoholic beverages/alcohol-containing products at least 72 hours prior to first dose, or plan to consume them at any time through completion of the Follow-up Visit; 9. Subjects who cannot refrain from strenuous exercise from 72 hours prior to dose administration through completion of the Follow-up Visit; 10. Subjects who have participated (taken investigative drug and/or device) in another clinical trial within 90 days prior to Screening; 11. Subjects who are employees of the study unit or their family members, students who are working in the study unit, or family members of the Investigator or Sponsor.

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As listed by the trial registrant

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

Healthy adult male

Contacts and locations

Locations

  • New Zealand Clinical Research (NZCR)

    Christchurch, 8011, New Zealand

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