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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002768-65 | EudraCT Number | ||
| U1111-1285-9850 | Other Identifier | WHO (World Health Organization) |
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The purpose of this study is to investigate what side effects the new compound LEO 158968 might cause and how well it is tolerated when it is used by healthy participants. It will also investigate how quickly and to what extent LEO 158968 is distributed and eliminated from the body and if LEO 158968 causes the body to make antibodies.
In the single ascending dose (SAD) cohorts, participants will receive escalating doses of LEO 158968 if the safety and tolerability results of the initial participants up to 48 hours (or 4 days for SC dosing) following dosing are acceptable to the Investigator.
In the multiple ascending dose (MAD) cohorts, the dose of LEO 158968 will be determined based on results derived from the earlier SAD cohorts and additional preclinical data from a 5-week good laboratory practice (GLP) cynomolgus monkey toxicology study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 158968 Single Ascending Dose (SAD) Cohorts | Experimental | Participants will receive a single dose of LEO 158968 or matching placebo via an intravenous (IV) infusion or subcutaneous (SC) injection. The dose of LEO 158968 will be increased per cohort. |
|
| LEO 158968 Multiple Ascending Dose (MAD) Cohorts | Experimental | Participants will receive 5 once weekly (QW) doses of LEO 158968 or matching placebo via a SC injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 158968 | Drug | IV infusion or SC injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-emergent Adverse Events (TEAEs) Reported for Each Participant | Any clinically significant changes from baseline in clinical laboratory parameters, vital signs including systolic and diastolic blood pressure, and abnormal clinically significant findings from physical examinations following first dose will be recorded as TEAEs. | Day 1 to Day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration-time Curve from Time 0 to Infinity (AUC0-∞) of LEO 158968 | Day 1 to Day 85 | |
| Area Under the Serum Concentration-time Curve from 0 Hours to 168 Hours (AUC0-168h) of LEO 158968 | Day 1 to Day 85 |
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Inclusion Criteria:
Exclusion Criteria:
A participant who meets any of the following exclusion criteria will not be eligible for inclusion in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEO Pharma Investigational Site | Groningen | 9728 | Netherlands |
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| Placebo |
| Drug |
IV infusion or SC injection |
|
| LEO 158968 | Drug | SC injection |
|
| Placebo | Drug | SC injection |
|
| Area Under the Serum Concentration-time Curve from t=0 to t (AUC0-t) of LEO 158968 | Where t corresponds to the last observed quantifiable concentration calculated by the linear up - logarithmic down trapezoidal rule. | Day 1 to Day 85 |
| Serum Concentration Observed at 168 Hours Post-dose (C168h) of LEO 158968 | Day 1 to Day 85 |
| Maximum Observed Serum Concentration (Cmax) of LEO 158968 | Day 1 to Day 85 |
| Apparent Terminal Half-life (t1/2) of LEO 158968 | Day 1 to Day 85 |
| Time of Last Quantifiable Concentration (tlast) of LEO 158968 | Day 1 to Day 85 |
| Time of Cmax (tmax) of LEO 158968 | Day 1 to Day 85 |
| Area Under the Serum Concentration-time Curve Over the Dosing Interval τ (ie, 168 hours) (AUCτ) of LEO 158968 | Day 1 to Day 113 |
| AUC0-t of LEO 158968 | Day 1 to Day 113 |
| Trough Serum Concentration Observed at the End of a Dosing Interval (168 hours post-dose) (Cτ) of LEO 158968 | Day 1 to Day 113 |
| Cmax of LEO 158968 | Day 1 to Day 113 |
| t1/2 of LEO 158968 | Day 1 to Day 113 |
| tlast of LEO 158968 | Day 1 to Day 113 |
| tmax of LEO 158968 | Day 1 to Day 113 |
| Number of Participants with Antidrug Antibodies (ADA) | Day 1 to Day 113 |