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BMO-2

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |Viatris Inc.|Last Updated: Mar 11, 2022

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment270
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02472912Adalimumab PK Bioequivalence Study to EU and US Sourced HumiraPHASE1 COMPLETED 270 — — Dec 1, 2014Jun 1, 2015Mar 11, 20221 Belgium
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Study Endpoints
Primary Endpoints
Area under the plasma concentration versus time curve (AUC) of adalimumab.
1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71 days post subcutaneous injection.
Secondary Endpoints
Frequency of Adverse Events
Up to 71 days.
Safey variable - Tolerability (injection site reactions)
Predose and 1, 2, 3, 7, 9, 36, and 71 days post subcutaneous injection.
Safety variable - immunogenicity (Presence of anti-adalimumab antibodies)
Day 1 (pre-dose) and Day 9, 29, and 71 days post subcutaneous injection.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeHEALTH_SERVICES_RESEARCH
Treatment Arms
ArmTypeDescription
Treatment AEXPERIMENTALSingle Injection of 40mg / 0.8 mL BMO-2
Treatment BACTIVE_COMPARATORSingle Injection of 40mg / 0.8 mL EU-Humira
Treatment CACTIVE_COMPARATORSingle Injection of 40mg / 0.8 mL US-Humira
Interventions
NameTypeDescription
BMO-2BIOLOGICALVolunteers randomized in Treatment A will receive a single subcutaneous injection of BMO-2 (40mg / 0.8mL).
EU-HumiraBIOLOGICALVolunteers randomized in Treatment B will receive a single subcutaneous injection of EU-Sourced Humira (40 mg / 0/8 mL)
US-HumiraBIOLOGICALVolunteers randomized in Treatment C, will receive a single subcutaneous injection of US-sourced Humira (40 mg / 0.8 mL).
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Weight: 60.0-95.0 kg. * Body mass index (BMI) : 19.0-30.0 kg/m2, inclusive * Medical history without major pathology. * Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg. * Computerized (12-lead) electrocardiogram (ECG) recording without signs of clinical...

Countries:Belgium
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