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New drug candidate LEO 158968 put to the test in healthy volunteers

NCT ID NCT05682352

Knowledge-focused Sponsor: LEO Pharma 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new compound called LEO 158968 in 120 healthy adults aged 18 to 60. The main goal was to check for side effects and see how well the drug is tolerated, as well as how it moves through and leaves the body. Participants received either the drug or a placebo in increasing doses. This study does not aim to treat any disease, but to gather important safety information for future research.

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

120 people

The number who actually took part.

Started

Feb 2023

Finished

Aug 2024

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 60 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: 1. Age: 18 to 60 years, inclusive, at screening 2. Sex: Male or female 3. Body mass index: 18.0 kg/m\^2 to 32.0 kg/m\^2, inclusive, at screening 4. Health status: In good health as judged by the Investigator based on medical history, physical examination, electrocardiogram (ECG), hematology, biochemistry, and urinalysis. Exclusion Criteria: A participant who meets any of the following exclusion criteria will not be eligible for inclusion in the study: 1. Male participants sexually active with a woman of childbearing potential who are not willing to use a barrier method of contraception (eg, condom) from the time of first dose of investigational medicinal product (IMP) until 16 weeks after the last dose, in conjunction with this female partner using a highly effective form of contraception. 2. Female participants who are pregnant, lactating, or planning to become pregnant during the time of the trial. 3. Participants with any surgical or medical condition which might significantly alter the distribution, metabolism, or excretion of any drug. 4. Positive polymerase chain reaction (PCR) test for coronavirus disease-19 (COVID-19) on Day -1, or contact with COVID-19 positive (or suspected) persons within 14 days prior to first dose. 5. ECG with QT-interval corrected for heart rate (QTc) using Fridericia's formula (QTcF) \>450 msec for men, \>460 msec for women, confirmed by repeat measurement at screening. 6. Treatment with any prescribed or nonprescribed systemic or topical medication within 7 days prior to the first dose of IMP (excluding paracetamol; including herbal remedies), unless, in the opinion of the Investigator and the Sponsor, the medication will not interfere with the trial procedures or compromise safety.

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As listed by the trial registrant

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

Healthy

Contacts and locations

Locations

  • LEO Pharma Investigational Site

    Groningen, 9728, Netherlands

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