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AZD4916

Phase 1

Healthy Participants | Small molecule | Other |AstraZeneca PLC|Last Updated: Apr 30, 2025

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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment178
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06951880A Study to Investigate the Safety and Pharmacokinetics of Single- and Multiple-ascending Doses of AZD4916 in Healthy VolunteersPHASE1 NOT YET_RECRUITING 178Jun 27, 2025Sep 24, 2026Apr 30, 20251 United Kingdom
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Study Endpoints
Primary Endpoints
Number of participants with adverse events (AEs)
From Screening (Day -29 to Day -2) up to 44 days

The safety and tolerability of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses to healthy participants (including Japanese and Chinese) will be assessed.

Secondary Endpoints
Area under concentration-time curve from time zero to infinity (AUCinf)
Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24
Area under concentration-time curve in the dosing interval (AUCtau)
Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD4916EXPERIMENTALParts 1a and 2a participants will receive a single oral dose of AZD4916 on Day 1. Parts 1b and 2b participants will receive a single oral dose of AZD4916 on Day 1 and multiple doses of AZD4916 on Days 4 through 17.
PlaceboPLACEBO_COMPARATORParts 1a and 2a participants will receive a single oral dose of placebo on Day 1. Parts 1b and 2b participants will receive a single dose placebo on Day 1 and multiple doses of placebo on Days 4 through 17.
Interventions
NameTypeDescription
AZD4916DRUGAZD4916 will be administered as oral solution.
PlaceboOTHERPlacebo will be administered as oral solution.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Main Inclusion Criteria: * Healthy male and female participants with suitable veins for cannulation or repeated venipuncture. * All females must have negative pregnancy test and females of childbearing potential must not be lactating and must agree to use an approved method of highly effective cont...

Countries:United Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06951880primaryCompletionDate: changed
LOWMay 24, 2026NCT06951880studyFirstPostDate: changed