HealthyPhase 1NCT04883333

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

A Phase 1 study testing LEO 153339 in people with Healthy, run by LEO Pharma at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LEO 153339
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 108 participants
Where: 1 siteNetherlands
Study dates: 17 May 2021to 18 Jul 2022
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

LEO Pharma Investigational Site
Groningen, NZ, 9728

Other trials in Netherlands

About this study

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

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.

Conditions: Healthy
Being tested: LEO 153339, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LEO 153339Drug
LEO 153339
PlaceboDrug
Placebo

Study groups in NCT04883333
Study group	Role	What they receive
Cohort A1 LEO 153339	Experimental	Single ascending dose (Part 1) Receives: Drug: LEO 153339
Cohort A2 LEO 153339	Experimental	Single ascending dose (Part 1) Receives: Drug: LEO 153339
Cohort A3 LEO 153339	Experimental	Single ascending dose (Part 1) Receives: Drug: LEO 153339
Cohort A4 LEO 153339	Experimental	Single ascending dose (Part 1) Receives: Drug: LEO 153339
Cohort A5 LEO 153339	Experimental	Single ascending dose (Part 1) Receives: Drug: LEO 153339
Cohort A6 LEO 153339	Experimental	Single ascending dose (Part 1) Receives: Drug: LEO 153339
Cohort A7 LEO 153339	Experimental	Single ascending dose (Part 1) Receives: Drug: LEO 153339
Cohort B1 LEO 153339	Experimental	Single ascending dose (Part 1) Receives: Drug: LEO 153339
All SAD cohorts placebo	Placebo comparator	Single ascending dose (Part 1), all participants receiving placebo in Cohorts A1-A7 and B1 Receives: Drug: Placebo
Cohort C1 LEO 153339	Experimental	Multiple ascending doses (Part 2) Receives: Drug: LEO 153339
Cohort C2 LEO 153339	Experimental	Multiple ascending doses (Part 2) Receives: Drug: LEO 153339
Cohort C3 LEO 153339	Experimental	Multiple ascending doses (Part 2) Receives: Drug: LEO 153339
Cohort C4 LEO 153339	Experimental	Multiple ascending doses (Part 2) Receives: Drug: LEO 153339
Cohort C5 LEO 153339	Experimental	Multiple ascending doses (Part 2) Receives: Drug: LEO 153339
Cohort C6 LEO 153339	Experimental	Multiple ascending doses (Part 2) Receives: Drug: LEO 153339
All MAD cohorts placebo	Placebo comparator	Multiple ascending doses (Part 2, all participants receiving placebo in Cohorts C1-C6) Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of treatment-emergent adverse events per subject.
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.
Measured: 4 days per subject (Part 1); 10 days per subject (Part 2)

Secondary outcomes (2)

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.
The pharmacokinetics of LEO 153339 and LEO 159074 will be evaluated in plasma.
Measured: 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.
The pharmacokinetics (PK) of LEO 153339 and LEO 159074 will be evaluated in plasma.
Measured: 10 days per subject

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 May 202118 Jul 2022

First posted12 May 2021
Study start17 May 2021
Primary completion18 Jul 2022
Study completion18 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04883333
Sponsor's protocol ID: LP0200-1495
Other IDs: 2020-005748-51, U1111-1283-2001
Status last verified: Apr 2023
First submitted: 11 May 2021
Last updated: 28 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of LEO 153339 in Healthy Subjects
ClinicalTrials.gov ID: NCT04883333
Acronym / sponsor ID: LP0200-1495
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Collaborators: ICON plc
Study start: 17 May 2021 (actual)
Primary completion: 18 Jul 2022 (actual)
Study completion: 18 Jul 2022 (actual)
First posted: 12 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 16

Arm	Type	Receives
Cohort A1 LEO 153339	Experimental	Drug: LEO 153339Single ascending dose (Part 1)
Cohort A2 LEO 153339	Experimental	Drug: LEO 153339Single ascending dose (Part 1)
Cohort A3 LEO 153339	Experimental	Drug: LEO 153339Single ascending dose (Part 1)
Cohort A4 LEO 153339	Experimental	Drug: LEO 153339Single ascending dose (Part 1)
Cohort A5 LEO 153339	Experimental	Drug: LEO 153339Single ascending dose (Part 1)
Cohort A6 LEO 153339	Experimental	Drug: LEO 153339Single ascending dose (Part 1)
Cohort A7 LEO 153339	Experimental	Drug: LEO 153339Single ascending dose (Part 1)
Cohort B1 LEO 153339	Experimental	Drug: LEO 153339Single ascending dose (Part 1)
All SAD cohorts placebo	Placebo comparator	Drug: PlaceboSingle ascending dose (Part 1), all participants receiving placebo in Cohorts A1-A7 and B1
Cohort C1 LEO 153339	Experimental	Drug: LEO 153339Multiple ascending doses (Part 2)
Cohort C2 LEO 153339	Experimental	Drug: LEO 153339Multiple ascending doses (Part 2)
Cohort C3 LEO 153339	Experimental	Drug: LEO 153339Multiple ascending doses (Part 2)
Cohort C4 LEO 153339	Experimental	Drug: LEO 153339Multiple ascending doses (Part 2)
Cohort C5 LEO 153339	Experimental	Drug: LEO 153339Multiple ascending doses (Part 2)
Cohort C6 LEO 153339	Experimental	Drug: LEO 153339Multiple ascending doses (Part 2)
All MAD cohorts placebo	Placebo comparator	Drug: PlaceboMultiple ascending doses (Part 2, all participants receiving placebo in Cohorts C1-C6)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LEO 153339LEO 153339	Drug	Cohort A1 LEO 153339, Cohort A2 LEO 153339, Cohort A3 LEO 153339, Cohort A4 LEO 153339, Cohort A5 LEO 153339, Cohort A6 LEO 153339, Cohort A7 LEO 153339, Cohort B1 LEO 153339, Cohort C1 LEO 153339, Cohort C2 LEO 153339, Cohort C3 LEO 153339, Cohort C4 LEO 153339, Cohort C5 LEO 153339, Cohort C6 LEO 153339
PlaceboPlacebo	Drug	All MAD cohorts placebo, All SAD cohorts placebo

Primary outcome

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.

2 secondary outcomes

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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Expert study director

LEO Pharma

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LEO 153339 in people with Healthy, run by LEO Pharma at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of treatment-emergent adverse events per subject. (time frame: 4 days per subject (Part 1); 10 days per subject (Part 2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04883333.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.