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MABp1

Phase 1

Healthy | Monoclonal antibody | Other |Johnson & Johnson|Last Updated: Feb 16, 2021

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03047317A Pharmacokinetic Study of MABp1 in Healthy VolunteersPHASE1 COMPLETED 6Feb 15, 2017Mar 31, 2017Feb 16, 20211 United States
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Study Endpoints
Primary Endpoints
Peak Plasma Concentration
2 weeks

Pharmacokinetics--blood levels of MABp1 antibody

Time to Peak Plasma Concentration
2 weeks

Pharmacokinetics--blood levels of MABp1 antibody

Half Life
2 weeks

Pharmacokinetics--blood levels of MABp1 antibody

Area under the plasma concentration versus time curve
2 weeks

Pharmacokinetics--blood levels of MABp1 antibody

Secondary Endpoints
Incidence of treatment emergent adverse events
2 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MABp1EXPERIMENTAL -
Interventions
NameTypeDescription
MABp1BIOLOGICALSingle dose of intravenous MABp1
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: ≥18 2. Adequate bone marrow function as defined as: * absolute neutrophil count (neutrophil and bands) of ≥ 1,500/mm3 (≥ 1.5 x 109/L) * platelet count \> 150,000/mm3 * hemoglobin of ≥ 10 g/dL 3. Adequate renal function, defined by serum creatinine ≤ 1.5 x lab U...

Countries:United States
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