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HSP-130

Phase 1

Neutropenia | Small molecule | Hematology |Pfizer, Inc.|Last Updated: Jul 15, 2016

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment153
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02629289A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy ParticipantsPHASE1 COMPLETED 153 — — Aug 1, 2015Jun 1, 2016Jul 15, 20161 Australia
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Study Endpoints
Primary Endpoints
Area under the effect versus time curve for absolute neutrophil count (ANC) from the time of dose administration to 288 hours after dose administration (AUECANC)
Within 1 hour prior to dose administration and at 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose.
Maximum observed value for ANC (ANC_Cmax)
Within 1 hour prior to dose administration and at 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose.
Secondary Endpoints
Time of maximum value for ANC (ANC_Tmax)
Within 1 hour prior to dose administration and at 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose.
Area under the serum pegylated filgrastim versus time curve from the time of dose administration to time infinity (AUC0-∞)
Within 1 hour prior to dose and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose.
Maximum observed serum pegylated filgrastim concentration (Cmax)
Within 1 hour prior to dose and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
Treatment AOTHERHSP-130, 6 mg, single subcutaneous (SC) injection in the deltoid region
Treatment BOTHERUS-approved Neulasta, 6 mg, single SC injection in the deltoid region
Treatment COTHEREU-approved Neulasta, 6 mg, single SC injection in the deltoid region
Interventions
NameTypeDescription
HSP-130DRUG -
US-approved NeulastaDRUG -
EU-approved NeulastaDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Provides written informed consent approved by an Independent Ethics Committee (IEC) prior to any study related activities 2. Healthy male or female volunteers between 18 and 65 years of age (both inclusive) 3. Body mass index (BMI) between 19 and 30 kg/m\^2, inclusive, and bo...

Countries:Australia
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