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ZN-d5

Phase 1

Healthy Volunteers | Small molecule | Other |Zentalis Pharmaceuticals, Inc.|Last Updated: Sep 19, 2024

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 Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04854174A Food Effect Study of ZN-d5 in Healthy Female VolunteersPHASE1 COMPLETED 16Jun 13, 2021Jul 5, 2021Sep 19, 20241 New Zealand
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Study Endpoints
Primary Endpoints
ZN-d5 Bioavailability
2 months

Maximum concentration (Cmax)

Secondary Endpoints
Safety and Tolerability of ZN-d5
2 Months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
Healthy VolunteerEXPERIMENTALHealthy Volunteer
Interventions
NameTypeDescription
ZN-d5DRUGOral agent; 25 mg formulation
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Eligibility Criteria
Age Range18 Years — 65 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy females, age 18-65 years; 2. Body mass index (BMI) ≥ 18.0 and ≤ 29.9 kg/m2 and weight ≥ 50 kg and ≤ 100 kg at Screening; 3. Non-smoker and must not have used any tobacco products within two months prior to Screening, or if a smoker, must be currently (and for the last...

Countries:New Zealand
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