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MOR106 single ascending doses,

Phase 1

Healthy | Small molecule | Dermatology |Galapagos NV|Last Updated: Oct 5, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment81
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02739009First in Human of Single and Multiple Doses of MOR106PHASE1 COMPLETED 81 — — Apr 1, 2016Aug 1, 2017Oct 5, 20174 Belgium, Hungary +2
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Study Endpoints
Primary Endpoints
Difference as compared to placebo in the number of subjects with treatment-emergent adverse events
Up to 99 days after dosing

To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo

Difference as compared to placebo in the number of subjects with deviating physical examination results
Up to 99 days after dosing

To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo

Difference as compared to placebo in the number of subjects with abnormal vital signs
Up to 99 days after dosing

To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo

Difference as compared to placebo in the number of subjects with abnormal 12-lead ECG results
Up to 99 days after dosing

To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo

Difference as compared to placebo in the number of subjects with abnormal laboratory findings
Up to 99 days after dosing

To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo

Difference as compared to placebo in the occurrence of infusion related reactions
Up to 99 days after dosing

To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo

Secondary Endpoints
Serum concentration (Cinf) of MOR106
up to 99 days after dosing
Area under the curve (AUC) of MOR106
up to 99 days after dosing
terminal elimination half-life (t1/2) of MOR106
up to 99 days after dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MOR106EXPERIMENTALSingle intravenous administration of MOR106
PlaceboPLACEBO_COMPARATORSingle intravenous administration of Placebo
MOR106 MADEXPERIMENTALMultiple intravenous administration of MOR106
Placebo MADPLACEBO_COMPARATORMultiple intravenous adminstration of Placebo
Interventions
NameTypeDescription
MOR106 single ascending doses, intravenousDRUG -
Placebo single ascending doses, intravenousDRUG -
MOR106 multiple ascending doses, intravenousDRUG -
Placebo multiple intravenous administrationsDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: \- Able and willing to give voluntary written informed consent Single ascending dose (SAD) * Negative urine drug screen * Male between 18-50 years of age * A body mass index (BMI) between 18-30 kg/m², inclusive. * Judged to be in good health Multiple ascending dose (MAD) * M...

Countries:BelgiumHungaryMoldovaRomania
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