24 Participants Needed

A Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects

LP
Overseen ByLEO Pharma A/S

Trial Summary

What is the purpose of this trial?

This trial will test a new drug called LEO 138559 in healthy Japanese people. It will check how the drug moves through their bodies, if it causes any immune reactions, and if it is safe to use.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications, including immunosuppressive or immunomodulating drugs, topical corticosteroids, topical calcineurin inhibitors, and over-the-counter medications or herbal remedies, before joining. Paracetamol/acetaminophen is allowed up to 2 g per day.

Research Team

ME

Medical Expert

Principal Investigator

LEO Pharma

Eligibility Criteria

Inclusion Criteria

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.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Treatment

Single treatment with either LEO 138559 or placebo administered subcutaneously up to 3 injections per dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

85 days
8 visits (in-person)

Treatment Details

Interventions

  • LEO 138559
  • Placebo
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: LEO 138559 Dose 3Experimental Treatment1 Intervention
LEO 138559 will be administered subcutaneously up to 3 injections per dosing
Group II: LEO 138559 Dose 2Experimental Treatment1 Intervention
LEO 138559 will be administered subcutaneously up to 3 injections per dosing
Group III: LEO 138559 Dose 1Experimental Treatment1 Intervention
LEO 138559 will be administered subcutaneously up to 3 injections per dosing
Group IV: PlaceboPlacebo Group1 Intervention
LEO 138559 placebo will be administered subcutaneously up to 3 injections per dosing

Find a Clinic Near You

Who Is Running the Clinical Trial?

LEO Pharma

Lead Sponsor

Trials
275
Recruited
189,000+
Christophe Bourdon profile image

Christophe Bourdon

LEO Pharma

Chief Executive Officer since 2022

Engineering degree from Université de Technologie de Compiègne

Dr. Siri Torhaug profile image

Dr. Siri Torhaug

LEO Pharma

Chief Medical Officer since 2022

MD, PhD

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