Recent Updates
Recently added Catalysts

ACP-501

Phase 1

Coronary Artery Disease | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Mar 14, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01554800Effect of ACP-501 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Subjects With Coronary Artery DiseasePHASE1 COMPLETED 16Mar 1, 2012Sep 1, 2012Mar 14, 20191 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Summary of Participants Experience with Safety and Tolerability
Day 1 to Day 28

Safety and tolerability of a single dose of ACP-501 as determined by adverse event reporting, clinical laboratory results, vital signs, physical examination, and electrocardiograms (ECGs).

Secondary Endpoints
Pharmacokinetic profile
Hours 0, 1, 6, 12, 24, 48, 72, 96, 168
Change in High-Density Lipoprotein-Cholesterol (HDL-C) value following a single dose
Hours 0, 1, 6, 12, 24, 48, 72, 96, 168
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ACP-501EXPERIMENTAL -
Interventions
NameTypeDescription
ACP-501DRUGA single dose infusion
Unlock Study Design Details
Eligibility Criteria
Age Range30 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * A history of stable documented CAD * Currently non-smoking males and females ages 30 to 85 years inclusive. o Female subjects of child-bearing potential (neither pregnant nor breast-feeding) must be using adequate birth control during study conduct. * Chronic concomitant me...

Countries:United States
Unlock Eligibility Criteria