A Single and Multiple Ascending-dose Trial of LEO 153339 in Healthy Adults

April 23, 2026 updated by: LEO Pharma

A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of LEO 153339 in Healthy Subjects

This is a first-in-human study in adult healthy participants consisting of two parts. In Part 1, participants will receive one dose of study drug (LEO 153339) or placebo; in Part 2, participants will receive multiple doses of study drug or placebo.

The participants will stay in the clinic for 6 days (Part 1) or for 12 days (Part 2) to have the study doctor assess their safety and to investigate how quickly and to what extent LEO 153339 (and the breakdown product) is absorbed, transported, and eliminated from the body.

The purpose is to assess the safety and tolerability of LEO 153339 when compared to a placebo with no active ingredient.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • NZ
      • Groningen, NZ, Netherlands, 9728
        • LEO Pharma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Main Inclusion Criteria:

  • Healthy adult males and females.
  • Age between 18 and 65 years (both inclusive) at screening.
  • A body mass index (BMI) between 18.0 and 32.0 kg/m² (both inclusive).
  • In good health at screening and/or check-in (Day -2 and Day -1) as judged by the investigator based on medical history, physical examination, vital signs, 12 lead electrocardiogram (ECG), and clinical laboratory evaluations.

Main Exclusion Criteria:

  • Male participants sexually active with a woman of childbearing potential who are not willing to use a barrier method of contraception (e.g. condom) from the time of first dose of investigational medicinal product (IMP) until 3 months after the last dose, in conjunction with this female partner using a highly effective form of contraception. For vasectomised male participants, male participants with a female partner with bilateral tubal occlusion or ligation, and heterosexually abstinent male participants (when this is in line with the preferred and usual life style of the participant and not just being without a current partner), no additional contraception is required.
  • Female participants who are pregnant, lactating, or of childbearing potential.
  • Any surgical or medical condition or cholecystectomy which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
  • Positive polymerase chain reaction (PCR) test for coronavirus disease 2019 (COVID-19) at Day -2 or Day -1 or within 8 weeks prior to screening or check-in, or contact with COVID-19 positive (or suspected) persons within 14 days prior to first dose.
  • Treatment with any prescribed or non-prescribed 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.
  • Treatment with any non-marketed drug substance (that is, an agent which has not yet been made available for clinical use following registration) within 3 months prior to the first dose of IMP.
  • ECG with QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 msec confirmed by repeat measurement at screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort A1 LEO 153339
Single ascending dose (Part 1)
Drug: LEO 153339
LEO 153339
Experimental: Cohort A2 LEO 153339
Single ascending dose (Part 1)
Drug: LEO 153339
LEO 153339
Experimental: Cohort A3 LEO 153339
Single ascending dose (Part 1)
Drug: LEO 153339
LEO 153339
Experimental: Cohort A4 LEO 153339
Single ascending dose (Part 1)
Drug: LEO 153339
LEO 153339
Experimental: Cohort A5 LEO 153339
Single ascending dose (Part 1)
Drug: LEO 153339
LEO 153339
Experimental: Cohort A6 LEO 153339
Single ascending dose (Part 1)
Drug: LEO 153339
LEO 153339
Experimental: Cohort A7 LEO 153339
Single ascending dose (Part 1)
Drug: LEO 153339
LEO 153339
Experimental: Cohort B1 LEO 153339
Single ascending dose (Part 1)
Drug: LEO 153339
LEO 153339
Placebo Comparator: All SAD cohorts placebo
Single ascending dose (Part 1), all participants receiving placebo in Cohorts A1-A7 and B1
Drug: Placebo
Placebo
Experimental: Cohort C1 LEO 153339
Multiple ascending doses (Part 2)
Drug: LEO 153339
LEO 153339
Experimental: Cohort C2 LEO 153339
Multiple ascending doses (Part 2)
Drug: LEO 153339
LEO 153339
Experimental: Cohort C3 LEO 153339
Multiple ascending doses (Part 2)
Drug: LEO 153339
LEO 153339
Experimental: Cohort C4 LEO 153339
Multiple ascending doses (Part 2)
Drug: LEO 153339
LEO 153339
Experimental: Cohort C5 LEO 153339
Multiple ascending doses (Part 2)
Drug: LEO 153339
LEO 153339
Experimental: Cohort C6 LEO 153339
Multiple ascending doses (Part 2)
Drug: LEO 153339
LEO 153339
Placebo Comparator: All MAD cohorts placebo
Multiple ascending doses (Part 2, all participants receiving placebo in Cohorts C1-C6)
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of treatment-emergent adverse events per subject.
Time Frame: 4 days per subject (Part 1); 10 days per subject (Part 2)
An adverse event will be considered treatment emergent if started after the first dose of investigational medicinal product (IMP) or if started before the first dose of IMP and worsened in severity after first dose of IMP.
4 days per subject (Part 1); 10 days per subject (Part 2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma concentration of LEO 153339 and LEO 159074 obtained from 0 to 72 hours post-dose in subjects from the single ascending-dose (SAD) cohorts.
Time Frame: 72 hours per subject
The pharmacokinetics of LEO 153339 and LEO 159074 will be evaluated in plasma.
72 hours per subject
Plasma concentration of LEO 153339 and LEO 159074 obtained from Day 1 to Day 7 post-dose with PK profiles on Day 1, Day 5, and Day 7 in subjects from the multiple ascending-dose (MAD) cohorts.
Time Frame: 10 days per subject
The pharmacokinetics (PK) of LEO 153339 and LEO 159074 will be evaluated in plasma.
10 days per subject

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LEO Pharma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ICON plc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Expert, LEO Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LP0200-1495
  • 2020-005748-51 (EudraCT Number)
  • U1111-1283-2001 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

IPD Sharing Time Frame

Data is available to request after results of the trial are available on leopharmatrials.com

IPD Sharing Access Criteria

Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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