HealthyPhase 1NCT03995550

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Doses of LEO 142397 in Healthy People, Including Japanese

A Phase 1 study testing LEO 142397 in people with Healthy, run by LEO Pharma at 1 site in United Kingdom.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

This is the first clinical trial with LEO 142397. The purpose of the trial is to assess the safety and tolerability of LEO 142397, along with the pharmacokinetics (what the body does to the drug) and the pharmacodynamics (what the drug does to the body) in healthy people. 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 142397
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 1 siteUnited Kingdom
Study dates: 3 Jul 2019to 16 Jul 2020
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

Who may be able to join

Body mass index of 18.0-32.0 kg/m2, inclusive.
In good health at screening and check-in as judged by the investigator based on medical history, physical examination, vital signs assessment, 12-lead electrocardiogram, and clinical laboratory evaluations:
Aspartate aminotransferase and alanine aminotransferase values ≤1.5 times the upper limit of normal.
Congenital nonhaemolytic hyperbilirubinaemia (including suspicion of Gilbert's syndrome) is not acceptable.
Haemoglobin value, neutrophil count, and lymphocyte count ≥ the lower limit of normal.
Female subjects of childbearing potential must use a highly effective form of birth control, in conjunction with adequate barrier contraception, from randomisation until 90 days after the follow-up visit.
Male subjects with female partner of childbearing potential must use adequate male barrier contraception, in conjunction with a highly effective form of female contraception for the partner, from randomisation until 90 days after the follow-up visit.

Who cannot join

Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
Any medication, including St. John's wort, known to chronically alter drug absorption or elimination processes within 30 days prior to the first dose.
History of any significant infectious disease, as assessed by the investigator, within 2 weeks prior to the first dose.
Current active tuberculosis based on QuantiFERON-TB Gold test.
Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibodies at screening.
Electrocardiogram abnormalities at screening or check-in.
Smoking of >10 cigarettes per day, on average, within the last 3 months.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Covance Clinical Research Unit Ltd.
Leeds, LS2 9LH

Other trials in United Kingdom

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LEO 142397 in Healthy Subjects

The trial consists of 2 parts:

In Part 1, participants will receive a single dose of LEO 142397. There will be up to 8 different dose groups.
In Part 2, participants will receive a daily dose of LEO 142397 for 14 days. There will be up to 6 different dose groups.

Each participant will be enrolled into 1 dose group in either Part 1 or Part 2.

Conditions: Healthy
Being tested: LEO 142397, Placebo

What participants receive

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

LEO 142397Drug
A compound in development by LEO Pharma A/S
PlaceboDrug
Placebo

Study groups in NCT03995550
Study group	Role	What they receive
Single ascending dose Cohort A	Experimental	Single dose of LEO 142397 or placebo. Receives: Drug: LEO 142397; Drug: Placebo
Single ascending dose Cohort B	Experimental	Single dose of LEO 142397 or placebo. Receives: Drug: LEO 142397; Drug: Placebo
Single ascending dose Cohort C	Experimental	2 single doses, separated by a washout of ≥7 days. Receives: Drug: LEO 142397; Drug: Placebo
Single ascending dose Cohort D	Experimental	2 single doses, separated by a washout of ≥7 days. Receives: Drug: LEO 142397; Drug: Placebo
Single ascending dose Cohort E	Experimental	Single dose of LEO 142397 or placebo. Receives: Drug: LEO 142397; Drug: Placebo
Single ascending dose Cohort F	Experimental	Single dose of LEO 142397 or placebo. Receives: Drug: LEO 142397; Drug: Placebo
Single ascending dose Cohort G	Experimental	Single dose of LEO 142397 or placebo. Receives: Drug: LEO 142397; Drug: Placebo
Single ascending dose Cohort H	Experimental	Single dose of LEO 142397 or placebo - tentative, female-only cohort (to be included only if the number of women recruited in the remaining cohorts is insufficient to assess the pharmacokinetics of LEO 142397 in women). Dose level ≥ that in Cohort C and ≤ that in Cohort D. Receives: Drug: LEO 142397; Drug: Placebo
Multiple ascending dose Cohort K	Experimental	Multiple doses of LEO 142397 or placebo. Receives: Drug: LEO 142397; Drug: Placebo
Multiple ascending dose Cohort L	Experimental	Multiple doses of LEO 142397 or placebo. Receives: Drug: LEO 142397; Drug: Placebo
Multiple ascending dose Cohort M	Experimental	Multiple doses of LEO 142397 or placebo. Receives: Drug: LEO 142397; Drug: Placebo
Multiple ascending dose Cohort N	Experimental	Multiple doses of LEO 142397 or placebo. Receives: Drug: LEO 142397; Drug: Placebo
Multiple ascending dose Cohort O	Experimental	Multiple doses of LEO 142397 or placebo. Receives: Drug: LEO 142397; Drug: Placebo
Multiple ascending dose Cohort P	Experimental	Multiple doses of LEO 142397 or placebo in Japanese-only subjects. Same dose level as for Cohort M. Receives: Drug: LEO 142397; Drug: Placebo

What is being measured

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

Part 1. Number of treatment-emergent adverse events per subject
Measured: From Day 1 (postdose) up to Day 8
Part 1. Having clinically significant abnormalities in systolic blood pressure
Clinical significance (yes/no) of abnormal values as judged by the investigator
Measured: From Day 1 (postdose) up to Day 8
Part 1. Having clinically significant abnormalities in diastolic blood pressure
Clinical significance (yes/no) of abnormal values as judged by the investigator
Measured: From Day 1 (postdose) up to Day 8
Part 1. Having clinically significant abnormalities in heart rate
Clinical significance (yes/no) of abnormal values as judged by the investigator
Measured: From Day 1 (postdose) up to Day 8
Part 1. Having clinically significant abnormalities in oral body temperature
Clinical significance (yes/no) of abnormal values as judged by the investigator
Measured: From Day 1 (postdose) up to Day 8
Part 1. Having an abnormal ECG
ECG: electrocardiogram. Abnormal ECG (yes/no) defined as: QT interval corrected for heart rate using Fridericia's formula (QTcF) of >450 msec for males / >470 msec for females, or change from baseline of >30 msec
Measured: From Day 1 (postdose) up to Day 8
Part 2. Number of treatment-emergent adverse events per subject
Measured: From Day 1 (postdose) up to Day 21
Part 2. Having clinically significant abnormalities in systolic blood pressure
Clinical significance (yes/no) of abnormal values as judged by the investigator
Measured: From Day 1 (postdose) up to Day 21
Part 2. Having clinically significant abnormalities in diastolic blood pressure
Clinical significance (yes/no) of abnormal values as judged by the investigator
Measured: From Day 1 (postdose) up to Day 21
Part 2. Having clinically significant abnormalities in heart rate
Clinical significance (yes/no) of abnormal values as judged by the investigator
Measured: From Day 1 (postdose) up to Day 21
Part 2. Having clinically significant abnormalities in oral body temperature
Clinical significance (yes/no) of abnormal values as judged by the investigator
Measured: From Day 1 (postdose) up to Day 21
Part 2. Having an abnormal ECG
ECG: electrocardiogram. Abnormal ECG (yes/no) defined as: QT interval corrected for heart rate using Fridericia's formula (QTcF) of >450 msec for males / >470 msec for females, or maximum change from baseline of >30 msec
Measured: From Day 1 (postdose) up to Day 21

Secondary outcomes (5)

Part 1. AUC0-∞
AUC0-∞: area under the plasma concentration-time curve from time zero to infinity
Measured: Derived from plasma concentration-time profile from 0-48 hours postdose
Part 1. Cmax
Cmax: maximum plasma concentration
Measured: Derived from plasma concentration-time profile from 0-48 hours postdose
Part 2. Accumulation ratio
Measured: Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14
Part 2. AUC0-24
AUC0-24: area under the plasma concentration-time curve from time zero to 24 hours postdose
Measured: Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14
Part 2. Cmax
Cmax: maximum plasma concentration
Measured: Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14

Timeline

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

3 Jul 201916 Jul 2020

First posted24 Jun 2019
Study start3 Jul 2019
Primary completion27 Jan 2020
Study completion16 Jul 2020

Why it stopped: Portfolio proritisation

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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03995550
Sponsor's protocol ID: LP0184-1415
Other IDs: 2018-004470-10, 2018
Status last verified: Aug 2019
First submitted: 21 Jun 2019
Last updated: 1 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

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?

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LEO 142397 in Healthy Subjects
ClinicalTrials.gov ID: NCT03995550
Acronym / sponsor ID: LP0184-1415
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Portfolio proritisation
Enrolment: 0 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: 3 Jul 2019 (actual)
Primary completion: 27 Jan 2020 (actual)
Study completion: 16 Jul 2020 (actual)
First posted: 24 Jun 2019 (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 trial consists of 2 parts:

In Part 1, participants will receive a single dose of LEO 142397. There will be up to 8 different dose groups.
In Part 2, participants will receive a daily dose of LEO 142397 for 14 days. There will be up to 6 different dose groups.

Each participant will be enrolled into 1 dose group in either Part 1 or Part 2.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 14

Arm	Type	Receives
Single ascending dose Cohort A	Experimental	Drug: LEO 142397, Drug: PlaceboSingle dose of LEO 142397 or placebo.
Single ascending dose Cohort B	Experimental	Drug: LEO 142397, Drug: PlaceboSingle dose of LEO 142397 or placebo.
Single ascending dose Cohort C	Experimental	Drug: LEO 142397, Drug: Placebo2 single doses, separated by a washout of ≥7 days.
Single ascending dose Cohort D	Experimental	Drug: LEO 142397, Drug: Placebo2 single doses, separated by a washout of ≥7 days.
Single ascending dose Cohort E	Experimental	Drug: LEO 142397, Drug: PlaceboSingle dose of LEO 142397 or placebo.
Single ascending dose Cohort F	Experimental	Drug: LEO 142397, Drug: PlaceboSingle dose of LEO 142397 or placebo.
Single ascending dose Cohort G	Experimental	Drug: LEO 142397, Drug: PlaceboSingle dose of LEO 142397 or placebo.
Single ascending dose Cohort H	Experimental	Drug: LEO 142397, Drug: PlaceboSingle dose of LEO 142397 or placebo - tentative, female-only cohort (to be included only if the number of women recruited in the remaining cohorts is insufficient to assess the pharmacokinetics of LEO 142397 in women). Dose level ≥ that in Cohort C and ≤ that in Cohort D.
Multiple ascending dose Cohort K	Experimental	Drug: LEO 142397, Drug: PlaceboMultiple doses of LEO 142397 or placebo.
Multiple ascending dose Cohort L	Experimental	Drug: LEO 142397, Drug: PlaceboMultiple doses of LEO 142397 or placebo.
Multiple ascending dose Cohort M	Experimental	Drug: LEO 142397, Drug: PlaceboMultiple doses of LEO 142397 or placebo.
Multiple ascending dose Cohort N	Experimental	Drug: LEO 142397, Drug: PlaceboMultiple doses of LEO 142397 or placebo.
Multiple ascending dose Cohort O	Experimental	Drug: LEO 142397, Drug: PlaceboMultiple doses of LEO 142397 or placebo.
Multiple ascending dose Cohort P	Experimental	Drug: LEO 142397, Drug: PlaceboMultiple doses of LEO 142397 or placebo in Japanese-only subjects. Same dose level as for Cohort M.

Who may qualify

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

Key inclusion criteria (7 listed)

Body mass index of 18.0-32.0 kg/m2, inclusive.
In good health at screening and check-in as judged by the investigator based on medical history, physical examination, vital signs assessment, 12-lead electrocardiogram, and clinical laboratory evaluations:
Female subjects of childbearing potential must use a highly effective form of birth control, in conjunction with adequate barrier contraception, from randomisation until 90 days after the follow-up visit.
Male subjects with female partner of childbearing potential must use adequate male barrier contraception, in conjunction with a highly effective form of female contraception for the partner, from randomisation until 90 days after the follow-up visit.

Key exclusion criteria (7 listed)

Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
Any medication, including St. John's wort, known to chronically alter drug absorption or elimination processes within 30 days prior to the first dose.
History of any significant infectious disease, as assessed by the investigator, within 2 weeks prior to the first dose.
Current active tuberculosis based on QuantiFERON-TB Gold test.
Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibodies at screening.

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 142397A compound in development by LEO Pharma A/S	Drug	Multiple ascending dose Cohort K, Multiple ascending dose Cohort L, Multiple ascending dose Cohort M, Multiple ascending dose Cohort N, Multiple ascending dose Cohort O, Multiple ascending dose Cohort P, Single ascending dose Cohort A, Single ascending dose Cohort B, Single ascending dose Cohort C, Single ascending dose Cohort D, Single ascending dose Cohort E, Single ascending dose Cohort F, Single ascending dose Cohort G, Single ascending dose Cohort H
PlaceboPlacebo	Drug	Multiple ascending dose Cohort K, Multiple ascending dose Cohort L, Multiple ascending dose Cohort M, Multiple ascending dose Cohort N, Multiple ascending dose Cohort O, Multiple ascending dose Cohort P, Single ascending dose Cohort A, Single ascending dose Cohort B, Single ascending dose Cohort C, Single ascending dose Cohort D, Single ascending dose Cohort E, Single ascending dose Cohort F, Single ascending dose Cohort G, Single ascending dose Cohort H

Primary outcome

Part 1. Number of treatment-emergent adverse events per subject
Time frame: From Day 1 (postdose) up to Day 8
Part 1. Having clinically significant abnormalities in systolic blood pressure
Time frame: From Day 1 (postdose) up to Day 8
Clinical significance (yes/no) of abnormal values as judged by the investigator
Part 1. Having clinically significant abnormalities in diastolic blood pressure
Time frame: From Day 1 (postdose) up to Day 8
Clinical significance (yes/no) of abnormal values as judged by the investigator
Part 1. Having clinically significant abnormalities in heart rate
Time frame: From Day 1 (postdose) up to Day 8
Clinical significance (yes/no) of abnormal values as judged by the investigator
Part 1. Having clinically significant abnormalities in oral body temperature
Time frame: From Day 1 (postdose) up to Day 8
Clinical significance (yes/no) of abnormal values as judged by the investigator
Part 1. Having an abnormal ECG
Time frame: From Day 1 (postdose) up to Day 8
ECG: electrocardiogram. Abnormal ECG (yes/no) defined as: QT interval corrected for heart rate using Fridericia's formula (QTcF) of >450 msec for males / >470 msec for females, or change from baseline of >30 msec
Part 2. Number of treatment-emergent adverse events per subject
Time frame: From Day 1 (postdose) up to Day 21
Part 2. Having clinically significant abnormalities in systolic blood pressure
Time frame: From Day 1 (postdose) up to Day 21
Clinical significance (yes/no) of abnormal values as judged by the investigator
Part 2. Having clinically significant abnormalities in diastolic blood pressure
Time frame: From Day 1 (postdose) up to Day 21
Clinical significance (yes/no) of abnormal values as judged by the investigator
Part 2. Having clinically significant abnormalities in heart rate
Time frame: From Day 1 (postdose) up to Day 21
Clinical significance (yes/no) of abnormal values as judged by the investigator
Part 2. Having clinically significant abnormalities in oral body temperature
Time frame: From Day 1 (postdose) up to Day 21
Clinical significance (yes/no) of abnormal values as judged by the investigator
Part 2. Having an abnormal ECG
Time frame: From Day 1 (postdose) up to Day 21
ECG: electrocardiogram. Abnormal ECG (yes/no) defined as: QT interval corrected for heart rate using Fridericia's formula (QTcF) of >450 msec for males / >470 msec for females, or maximum change from baseline of >30 msec

5 secondary outcomes

Part 1. AUC0-∞
Time frame: Derived from plasma concentration-time profile from 0-48 hours postdose
Part 1. Cmax
Time frame: Derived from plasma concentration-time profile from 0-48 hours postdose
Part 2. Accumulation ratio
Time frame: Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14
Part 2. AUC0-24
Time frame: Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14
Part 2. Cmax
Time frame: Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
Individual participant dataSharing planned: Yes

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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 142397 in people with Healthy, run by LEO Pharma at 1 site in United Kingdom.

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

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 1 May 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 United Kingdom. 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. 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 was withdrawn before enrolling participants, so there are no results.

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?

Part 1. Number of treatment-emergent adverse events per subject (time frame: From Day 1 (postdose) up to Day 8). The study lists 12 primary outcomes in all. 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 NCT03995550.

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 1 May 2026.