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PF-06293620

Phase 1

Type 2 Diabetes Mellitus | Monoclonal antibody | Metabolic |Pfizer, Inc.|Last Updated: Oct 16, 2018

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment84
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02211261A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes MellitusPHASE1 COMPLETED 84Sep 15, 2014Jan 27, 2017Oct 16, 20187 United States
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Study Endpoints
Primary Endpoints
Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events
Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) or Day 169 (for MAD cohorts) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs. Causality with the study treatment was determined by the investigator.

Number of Participants With Dose Limiting or Intolerable Adverse Events
Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts

Dose limiting or intolerable AEs were originally planned to be collected. However, this outcome measure was not actually summarized, since collection and monitoring of treatment-emergent AEs was performed during the study, and deemed sufficient to ensure the participants safety.

Number of Participants With Positive Anti-drug Antibody (ADA) Result
Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts

ADA against PF-06293620 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer \>=1.88 was considered positive.

Secondary Endpoints
Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts)
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts)
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort 1-PF-06293620 or placeboEXPERIMENTALSingle Ascending Dose PF-06293620 or placebo
Cohort 2-PF-06293620 or placeboEXPERIMENTALSingle Ascending Dose PF-06293620 or placebo
Cohort 3-PF-06293620 or placeboEXPERIMENTALSingle Ascending Dose PF-06293620 or placebo
Cohort 4-PF-06293620 or placeboEXPERIMENTALSingle Ascending Dose PF-06293620 or placebo
Cohort 5-PF-06293620 or placeboEXPERIMENTALSingle Ascending Dose PF-06293620 or placebo
Cohort 6-PF-06293620 or placeboEXPERIMENTALMultiple Ascending Dose PF-06293620 or placebo
Cohort 7 PF-06293620 or placeboEXPERIMENTALMultiple Ascending Dose PF-06293620 or placebo
Cohort 8-PF-06293620 or placeboEXPERIMENTALMultiple Ascending Dose PF-06293620 or placebo
Cohort 9-PF-06293620 or placeboEXPERIMENTALMultiple Ascending Dose PF-06293620 or placebo
Interventions
NameTypeDescription
PF-06293620BIOLOGICALsubcutaneous, single dose 0.3 mg/kg
PlaceboBIOLOGICALSubcutaneous normal saline single dose
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Men and women of non-childbearing potential with Type 2 Diabetes Mellitus * Subjects on stable doses of metformin \>/= 1500 mg daily (SAD cohorts) or \>/= 1000 mg daily (MAD cohorts) x 30 days prior to screening * HbA1c 7-10% (SAD Cohorts) or 6.5-10% (MAD cohorts) inclusive at...

Countries:United States
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