Atopic DermatitisPhase 1NCT05099133
A Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects
A Phase 1 study testing LEO 138559 in people with Atopic Dermatitis, run by LEO Pharma at 1 site in United States.
Trial summary
This trial will investigate the pharmacokinetics, immunogenicity, safety, and tolerability of LEO 138559 in healthy Japanese subjects. The trial consists of a screening period of up to 4 weeks, a single treatment with either LEO 138559 or placebo, and 8 follow-up visits to Day 85. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- LEO 138559
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2021to 28 Jun 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
Who may be able to join
- Males and females between 18 to 65 years of age, inclusive, at the Screening visit
- Japanese subjects to be considered ethnic Japanese must:
- Be born in Japan with parents and grandparents (maternal and paternal) of Japanese descent
- Not have lived outside of Japan for more than 10 years at the time of Screening
- No significant change in lifestyle since leaving Japan, including diet.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, at the Screening visit.
- Healthy, determined by pre-trial medical evaluation at Principal Investigator's discretion
Who cannot join
- Female subjects of childbearing potential who are not willing to use highly effective contraception.
- Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, musculoskeletal, infectious, metabolic, hematologic, neurological, or psychiatric disorder(s) as determined by the Principal Investigator or designee.
- Subject has any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of any drug as determined by the Principal Investigator or designee.
- Clinically significant infection within 4 weeks prior to randomization that may compromise the safety of the subject in the trial or the integrity of the trial. This includes clinically significant infections (common cold is allowed [with negative SARS-CoV-2 PCR test]) that in the opinion of the Investigator or Sponsor's Medical Monitor may compromise the safety of the subject in the trial, interfere with evaluation of the IMP, or reduce the subject's ability to participate in the trial.
- History of any active skin infection within 1 week prior to Screening or randomization.
- Subject who has taken immunosuppressive/immunomodulating medication within 4 weeks prior to randomization, topical corticosteroids, topical calcineurin inhibitors within 2 weeks prior to randomization, or was treated with biologics within 5 half-lives (if known) or 12 weeks prior to randomization, whichever is longer.
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- Subject has used over-the-counter (OTC) medications (including vitamins), or herbal remedies from 14 days prior to admission until the End-of-trial Visit. By exception, paracetamol/acetaminophen ≤ 2 g per day is permitted.
- History of chronic alcohol or drug abuse within 12 months prior to Screening, or any condition associated with poor compliance as judged by the Investigator.
- Heavy smoker (daily average >10 cigarettes) within the last three months prior to Screening.
- Subject is unwilling to avoid use of alcohol or alcohol-containing foods, medications, or beverages, within 36 hours prior to admission until discharge from the Clinical Unit.
- Female subjects are breastfeeding or female subjects with a positive serum pregnancy test at the Screening visit or urine pregnancy test at admission.
- Subject is unwilling to avoid consumption of coffee and caffeine-containing beverages within 48 hours prior to admission until discharge from the Clinical Unit.
- Subject is unable to abstain from smoking (or other nicotine use) from admission until discharge from the Clinical Unit.
- Subject scheduled to receive COVID-19 vaccination within 2 weeks before IMP administration.
- Less than 4 weeks after the second COVID-19 vaccination or booster (if on a single dose vaccination, it should be 4 weeks after).
- Live attenuated viral vaccine administration within 12 weeks before LEO 138559 or planned within three months after the last administration of LEO 138559.
Trial locations and contacts
1 site in 1 country.
United States1 site
LEO Investigational Site
Los Angeles, California, 91206
About this study
Official title: A Phase 1, Single-center, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects
This trial will investigate the pharmacokinetics, immunogenicity, safety, and tolerability of LEO 138559 in healthy Japanese subjects.
The trial consists of a screening period of up to 4 weeks, a single treatment with either LEO 138559 or placebo, and 8 follow-up visits to Day 85.
A total of 24 healthy subjects will be enrolled in 3 dose groups (n=8 per dose group) and randomized to either LEO 138559 or placebo in a ratio of 6:2.
- Conditions
- Atopic Dermatitis
- Being tested
- LEO 138559, LEO 138559 Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 138559Drug
LEO 138559 is an antibody given by injection just under the skin.
LEO 138559 PlaceboDrug
LEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except the medical ingredient LEO 138559.
| Study group | Role | What they receive |
|---|---|---|
| LEO 138559 Dose 1 | Experimental | LEO 138559 will be administered subcutaneously up to 3 injections per dosing Receives: Drug: LEO 138559 |
| LEO 138559 Dose 2 | Experimental | LEO 138559 will be administered subcutaneously up to 3 injections per dosing Receives: Drug: LEO 138559 |
| LEO 138559 Dose 3 | Experimental | LEO 138559 will be administered subcutaneously up to 3 injections per dosing Receives: Drug: LEO 138559 |
| Placebo | Placebo comparator | LEO 138559 placebo will be administered subcutaneously up to 3 injections per dosing Receives: Drug: LEO 138559 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-last: the area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration
Pharmacokinetic endpoint to be determined from serum concentrations
Measured: From Day 1 to Day 85
AUC0-inf: area under the concentration-time curve from pre-dose (time 0) extrapolated to infinite time
Pharmacokinetic endpoint to be determined from serum concentrations
Measured: From Day 1 to Day 85
Cmax: maximum serum LEO 138559 concentration
Pharmacokinetic endpoint to be determined from serum concentrations
Measured: From Day 1 to Day 85
tmax: time of maximum serum LEO 138559 concentration
Pharmacokinetic endpoint to be determined from serum concentrations
Measured: From Day 1 to Day 85
t½: terminal elimination half-life
Pharmacokinetic endpoint to be determined from serum concentrations
Measured: From Day 1 to Day 85
CL/F: apparent total body clearance
Pharmacokinetic endpoint to be determined from serum concentrations
Measured: From Day 1 to Day 85
Vz/F: apparent volume of distribution
Pharmacokinetic endpoint to be determined from serum concentrations
Measured: From Day 1 to Day 85
Secondary outcomes (2)
Number of treatment emergent adverse events
Measured: From Day 1 to Day 85
Presence of binding anti-drug antibodies
Measured: Day 1(pre-dose), Day 29, Day 57, and Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start3 Nov 2021
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099133
- Sponsor's protocol ID
- LP0145-1486
- Status last verified
- Jul 2022
- First submitted
- 18 Oct 2021
- Last updated
- 24 Feb 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT05099133
- Acronym / sponsor ID
- LP0145-1486
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 29 Oct 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.
This trial will investigate the pharmacokinetics, immunogenicity, safety, and tolerability of LEO 138559 in healthy Japanese subjects.
The trial consists of a screening period of up to 4 weeks, a single treatment with either LEO 138559 or placebo, and 8 follow-up visits to Day 85.
A total of 24 healthy subjects will be enrolled in 3 dose groups (n=8 per dose group) and randomized to either LEO 138559 or placebo in a ratio of 6:2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LEO 138559 Dose 1 | Experimental | Drug: LEO 138559LEO 138559 will be administered subcutaneously up to 3 injections per dosing |
| LEO 138559 Dose 2 | Experimental | Drug: LEO 138559LEO 138559 will be administered subcutaneously up to 3 injections per dosing |
| LEO 138559 Dose 3 | Experimental | Drug: LEO 138559LEO 138559 will be administered subcutaneously up to 3 injections per dosing |
| Placebo | Placebo comparator | Drug: LEO 138559 PlaceboLEO 138559 placebo will be administered subcutaneously up to 3 injections per dosing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females between 18 to 65 years of age, inclusive, at the Screening visit
- Japanese subjects to be considered ethnic Japanese must:
- Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, at the Screening visit.
- Healthy, determined by pre-trial medical evaluation at Principal Investigator's discretion
Key exclusion criteria (16 listed)
- Female subjects of childbearing potential who are not willing to use highly effective contraception.
- Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, musculoskeletal, infectious, metabolic, hematologic, neurological, or psychiatric disorder(s) as determined by the Principal Investigator or designee.
- Subject has any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of any drug as determined by the Principal Investigator or designee.
- Clinically significant infection within 4 weeks prior to randomization that may compromise the safety of the subject in the trial or the integrity of the trial. This includes clinically significant infections (common cold is allowed [with negative SARS-CoV-2 PCR test]) that in the opinion of the Investigator or Sponsor's Medical Monitor may compromise the safety of the subject in the trial, interfere with evaluation of the IMP, or reduce the subject's ability to participate in the trial.
- History of any active skin infection within 1 week prior to Screening or randomization.
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 138559LEO 138559 is an antibody given by injection just under the skin. | Drug | LEO 138559 Dose 1, LEO 138559 Dose 2, LEO 138559 Dose 3 |
| LEO 138559 PlaceboLEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except the medical ingredient LEO 138559. | Drug | Placebo |
Primary outcome
AUC0-last: the area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration
Time frame: From Day 1 to Day 85
Pharmacokinetic endpoint to be determined from serum concentrations
AUC0-inf: area under the concentration-time curve from pre-dose (time 0) extrapolated to infinite time
Time frame: From Day 1 to Day 85
Pharmacokinetic endpoint to be determined from serum concentrations
Cmax: maximum serum LEO 138559 concentration
Time frame: From Day 1 to Day 85
Pharmacokinetic endpoint to be determined from serum concentrations
tmax: time of maximum serum LEO 138559 concentration
Time frame: From Day 1 to Day 85
Pharmacokinetic endpoint to be determined from serum concentrations
t½: terminal elimination half-life
Time frame: From Day 1 to Day 85
Pharmacokinetic endpoint to be determined from serum concentrations
CL/F: apparent total body clearance
Time frame: From Day 1 to Day 85
Pharmacokinetic endpoint to be determined from serum concentrations
Vz/F: apparent volume of distribution
Time frame: From Day 1 to Day 85
Pharmacokinetic endpoint to be determined from serum concentrations
2 secondary outcomes
Number of treatment emergent adverse events
Time frame: From Day 1 to Day 85
Presence of binding anti-drug antibodies
Time frame: Day 1(pre-dose), Day 29, Day 57, and Day 85
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 24 Feb 2025.
- 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 138559 in people with Atopic Dermatitis, run by LEO Pharma at 1 site in United States.
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 16 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: finished, as of the sponsor's last update on 24 Feb 2025. 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 States. 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?
AUC0-last: the area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (time frame: From Day 1 to Day 85). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2025.