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出境医 / 临床实验 / Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Doses of LEO 142397 in Healthy People, Including Japanese

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

Study Description
Brief 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.

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: LEO 142397 Drug: Placebo Phase 1

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Single ascending dose Cohort A
Single dose of LEO 142397 or placebo.
 Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo
Experimental: Single ascending dose Cohort B
Single dose of LEO 142397 or placebo.
 Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo
Experimental: Single ascending dose Cohort C
2 single doses, separated by a washout of ≥7 days.
 Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo
Experimental: Single ascending dose Cohort D
2 single doses, separated by a washout of ≥7 days.
 Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo
Experimental: Single ascending dose Cohort E
Single dose of LEO 142397 or placebo.
 Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo
Experimental: Single ascending dose Cohort F
Single dose of LEO 142397 or placebo.
 Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo
Experimental: Single ascending dose Cohort G
Single dose of LEO 142397 or placebo.
 Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo
Experimental: Single ascending dose Cohort H
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.
 Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo
Experimental: Multiple ascending dose Cohort K
Multiple doses of LEO 142397 or placebo.
 Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo
Experimental: Multiple ascending dose Cohort L
Multiple doses of LEO 142397 or placebo.
 Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo
Experimental: Multiple ascending dose Cohort M
Multiple doses of LEO 142397 or placebo.
 Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo
Experimental: Multiple ascending dose Cohort N
Multiple doses of LEO 142397 or placebo.
 Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo
Experimental: Multiple ascending dose Cohort O
Multiple doses of LEO 142397 or placebo.
 Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo
Experimental: Multiple ascending dose Cohort P
Multiple doses of LEO 142397 or placebo in Japanese-only subjects. Same dose level as for Cohort M.
 Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo
Outcome Measures
Primary Outcome Measures :
  1. Part 1. Number of treatment-emergent adverse events per subject [ Time Frame: From Day 1 (postdose) up to Day 8 ]
  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Part 2. Number of treatment-emergent adverse events per subject [ Time Frame: From Day 1 (postdose) up to Day 21 ]
  8. 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

  9. 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

  10. 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

  11. 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

  12. 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


Secondary Outcome Measures :
  1. Part 1. AUC0-∞ [ Time Frame: Derived from plasma concentration-time profile from 0-48 hours postdose ]
    AUC0-∞: area under the plasma concentration-time curve from time zero to infinity

  2. Part 1. Cmax [ Time Frame: Derived from plasma concentration-time profile from 0-48 hours postdose ]
    Cmax: maximum plasma concentration

  3. Part 2. Accumulation ratio [ Time Frame: Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14 ]
  4. Part 2. AUC0-24 [ Time Frame: Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14 ]
    AUC0-24: area under the plasma concentration-time curve from time zero to 24 hours postdose

  5. Part 2. Cmax [ Time Frame: Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14 ]
    Cmax: maximum plasma concentration


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key inclusion Criteria:

  • 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.

Key exclusion criteria:

  • 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.
Contacts and Locations

Locations
Layout table for location information
United Kingdom
Covance Clinical Research Unit Ltd.
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
LEO Pharma
Investigators
Layout table for investigator information
Study Director: Medical Expert LEO Pharma
Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date August 5, 2019
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • 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 ]
    Abnormal ECG (yes/no) defined as: QTcF interval 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 ]
    Abnormal ECG (yes/no) defined as: QTcF interval of >450 msec for males / >470 msec for females, or maximum change from baseline of >30 msec
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Part 1. AUC0-∞ [ Time Frame: Derived from plasma concentration-time profile from 0-48 hours postdose ]
    AUC0-∞: area under the plasma concentration-time curve from time zero to infinity
  • Part 1. Cmax [ Time Frame: Derived from plasma concentration-time profile from 0-48 hours postdose ]
    Cmax: maximum plasma concentration
  • 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 ]
    AUC0-24: area under the plasma concentration-time curve from time zero to 24 hours postdose
  • Part 2. Cmax [ Time Frame: Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14 ]
    Cmax: maximum plasma concentration
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Doses of LEO 142397 in Healthy People, Including Japanese
Official Title  ICMJE 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
Brief 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.

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: LEO 142397
    A compound in development by LEO Pharma A/S
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Single ascending dose Cohort A
    Single dose of LEO 142397 or placebo.
    Interventions:
    • Drug: LEO 142397
    • Drug: Placebo
  • Experimental: Single ascending dose Cohort B
    Single dose of LEO 142397 or placebo.
    Interventions:
    • Drug: LEO 142397
    • Drug: Placebo
  • Experimental: Single ascending dose Cohort C
    2 single doses, separated by a washout of ≥7 days.
    Interventions:
    • Drug: LEO 142397
    • Drug: Placebo
  • Experimental: Single ascending dose Cohort D
    2 single doses, separated by a washout of ≥7 days.
    Interventions:
    • Drug: LEO 142397
    • Drug: Placebo
  • Experimental: Single ascending dose Cohort E
    Single dose of LEO 142397 or placebo.
    Interventions:
    • Drug: LEO 142397
    • Drug: Placebo
  • Experimental: Single ascending dose Cohort F
    Single dose of LEO 142397 or placebo.
    Interventions:
    • Drug: LEO 142397
    • Drug: Placebo
  • Experimental: Single ascending dose Cohort G
    Single dose of LEO 142397 or placebo.
    Interventions:
    • Drug: LEO 142397
    • Drug: Placebo
  • Experimental: Single ascending dose Cohort H
    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.
    Interventions:
    • Drug: LEO 142397
    • Drug: Placebo
  • Experimental: Multiple ascending dose Cohort K
    Multiple doses of LEO 142397 or placebo.
    Interventions:
    • Drug: LEO 142397
    • Drug: Placebo
  • Experimental: Multiple ascending dose Cohort L
    Multiple doses of LEO 142397 or placebo.
    Interventions:
    • Drug: LEO 142397
    • Drug: Placebo
  • Experimental: Multiple ascending dose Cohort M
    Multiple doses of LEO 142397 or placebo.
    Interventions:
    • Drug: LEO 142397
    • Drug: Placebo
  • Experimental: Multiple ascending dose Cohort N
    Multiple doses of LEO 142397 or placebo.
    Interventions:
    • Drug: LEO 142397
    • Drug: Placebo
  • Experimental: Multiple ascending dose Cohort O
    Multiple doses of LEO 142397 or placebo.
    Interventions:
    • Drug: LEO 142397
    • Drug: Placebo
  • Experimental: Multiple ascending dose Cohort P
    Multiple doses of LEO 142397 or placebo in Japanese-only subjects. Same dose level as for Cohort M.
    Interventions:
    • Drug: LEO 142397
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 1, 2019) 		0
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2019) 		138
Estimated Study Completion Date  ICMJE August 1, 2019
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key inclusion Criteria:

  • 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.

Key exclusion criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03995550
Other Study ID Numbers  ICMJE LP0184-1415
2018-004470-10 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data feasibility requests and research proposals are sent to disclosure@leo-pharma.com. If feasibility to share the data from a trial is granted, the ultimate decision is made by an external to the company board (Patient and Scientific Review Board). Data sharing is further subject to signed data sharing agreement. Data will be available in a closed environment for a specified period on time.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Access Criteria: External researchers with no commercial interest who provide scientifically sound research proposal
URL: http://www.leo-pharma.com/Home/Research-and-Development/Clinical-trial-disclosure/Access-to-patient-level-data.aspx
Responsible Party LEO Pharma
Study Sponsor  ICMJE LEO Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Expert LEO Pharma
PRS Account LEO Pharma
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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