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

NCT ID: NCT04883333

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-17

Study Completion Date

2022-07-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort A1 LEO 153339

Single ascending dose (Part 1)

Group Type EXPERIMENTAL

LEO 153339

Intervention Type DRUG

LEO 153339

Cohort A2 LEO 153339

Single ascending dose (Part 1)

Group Type EXPERIMENTAL

LEO 153339

Intervention Type DRUG

LEO 153339

Cohort A3 LEO 153339

Single ascending dose (Part 1)

Group Type EXPERIMENTAL

LEO 153339

Intervention Type DRUG

LEO 153339

Cohort A4 LEO 153339

Single ascending dose (Part 1)

Group Type EXPERIMENTAL

LEO 153339

Intervention Type DRUG

LEO 153339

Cohort A5 LEO 153339

Single ascending dose (Part 1)

Group Type EXPERIMENTAL

LEO 153339

Intervention Type DRUG

LEO 153339

Cohort A6 LEO 153339

Single ascending dose (Part 1)

Group Type EXPERIMENTAL

LEO 153339

Intervention Type DRUG

LEO 153339

Cohort A7 LEO 153339

Single ascending dose (Part 1)

Group Type EXPERIMENTAL

LEO 153339

Intervention Type DRUG

LEO 153339

Cohort B1 LEO 153339

Single ascending dose (Part 1)

Group Type EXPERIMENTAL

LEO 153339

Intervention Type DRUG

LEO 153339

All SAD cohorts placebo

Single ascending dose (Part 1), all participants receiving placebo in Cohorts A1-A7 and B1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Cohort C1 LEO 153339

Multiple ascending doses (Part 2)

Group Type EXPERIMENTAL

LEO 153339

Intervention Type DRUG

LEO 153339

Cohort C2 LEO 153339

Multiple ascending doses (Part 2)

Group Type EXPERIMENTAL

LEO 153339

Intervention Type DRUG

LEO 153339

Cohort C3 LEO 153339

Multiple ascending doses (Part 2)

Group Type EXPERIMENTAL

LEO 153339

Intervention Type DRUG

LEO 153339

Cohort C4 LEO 153339

Multiple ascending doses (Part 2)

Group Type EXPERIMENTAL

LEO 153339

Intervention Type DRUG

LEO 153339

Cohort C5 LEO 153339

Multiple ascending doses (Part 2)

Group Type EXPERIMENTAL

LEO 153339

Intervention Type DRUG

LEO 153339

Cohort C6 LEO 153339

Multiple ascending doses (Part 2)

Group Type EXPERIMENTAL

LEO 153339

Intervention Type DRUG

LEO 153339

All MAD cohorts placebo

Multiple ascending doses (Part 2, all participants receiving placebo in Cohorts C1-C6)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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LEO 153339

LEO 153339

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ICON plc

INDUSTRY

Sponsor Role collaborator

LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Expert

Role: STUDY_DIRECTOR

LEO Pharma

Locations

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LEO Pharma Investigational Site

Groningen, NZ, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2020-005748-51

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1283-2001

Identifier Type: OTHER

Identifier Source: secondary_id

LP0200-1495

Identifier Type: -

Identifier Source: org_study_id

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