Recent Updates
Recently added Catalysts

MOR106

Phase 1

Healthy | Small molecule | Dermatology |Lakefront Biotherapeutics|Last Updated: Oct 5, 2017

Target and mechanism

ModalitySmall molecule

Also known as MOR106 single ascending doses, intravenous, MOR106 single ascending doses

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment81

FDA Designations

No designations recorded

Clinical trial landscape

MOR106 · 1 trial · 2 indications

Phase 1 1
NCT02739009First in Human of Single and Multiple Doses of MOR106Healthy
COMPLETED81 Analytics
PHASE1COMPLETED
First in Human of Single and Multiple Doses of MOR106
HealthyUnlock trial analytics

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
Unlock Study Endpoints

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 -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria