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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 138559 Dose 1 | Experimental | LEO 138559 will be administered subcutaneously up to 3 injections per dosing |
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| LEO 138559 Dose 2 | Experimental | LEO 138559 will be administered subcutaneously up to 3 injections per dosing |
|
| LEO 138559 Dose 3 | Experimental | LEO 138559 will be administered subcutaneously up to 3 injections per dosing |
|
| Placebo | Placebo Comparator | LEO 138559 placebo will be administered subcutaneously up to 3 injections per dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 138559 | Drug | LEO 138559 is an antibody given by injection just under the skin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | From Day 1 to Day 85 |
| Cmax: maximum serum LEO 138559 concentration | Pharmacokinetic endpoint to be determined from serum concentrations | From Day 1 to Day 85 |
| tmax: time of maximum serum LEO 138559 concentration | Pharmacokinetic endpoint to be determined from serum concentrations | From Day 1 to Day 85 |
| t½: terminal elimination half-life | Pharmacokinetic endpoint to be determined from serum concentrations | From Day 1 to Day 85 |
| CL/F: apparent total body clearance | Pharmacokinetic endpoint to be determined from serum concentrations | From Day 1 to Day 85 |
| Vz/F: apparent volume of distribution | Pharmacokinetic endpoint to be determined from serum concentrations | From Day 1 to Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events | From Day 1 to Day 85 | |
| Presence of binding anti-drug antibodies | Day 1(pre-dose), Day 29, Day 57, and Day 85 |
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Inclusion Criteria
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
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEO Investigational Site | Los Angeles | California | 91206 | United States |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| LEO 138559 Placebo | Drug | 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. |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |