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AZD4916

Phase 1

Healthy Participants | Small molecule | Other |AstraZeneca PLC|Last Updated: Aug 26, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

AZD4916 · 1 trial · 1 indication

Phase 1 1
NCT06951880A Study to Investigate the Safety and Pharmacokinetics of Single- and Multiple-ascending Doses of AZD4916 in Healthy VolunteersHealthy Participants
RECRUITING160 Analytics
PHASE1RECRUITING
A Study to Investigate the Safety and Pharmacokinetics of Single- and Multiple-ascending Doses of AZD4916 in Healthy Volunteers
Healthy ParticipantsUnlock trial analytics

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 to 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

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 StatesUnited Kingdom
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Recent Changes (Last 90 Days)

LOWAug 26, 2026NCT06951880Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 26, 2026NCT06951880Status: NOT_YET_RECRUITING → RECRUITING
MEDIUMJun 16, 2026NCT06951880Enrollment: 178 → 160
MEDIUMJun 16, 2026NCT06951880Enrollment: 178 → 160
MEDIUMJun 16, 2026NCT06951880Enrollment: 178 → 160
MEDIUMJun 16, 2026NCT06951880Enrollment: 178 → 160

Frequently asked questions about AZD4916

What is AZD4916 used for?

AZD4916 is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with a single active trial evaluating its safety and pharmacokinetics. The drug is not approved for any indication and remains under investigation.

Who makes AZD4916?

AZD4916 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting a Phase 1 clinical trial to investigate the drug's safety and pharmacokinetics in healthy volunteers.

What phase is AZD4916 in?

AZD4916 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to study the safety and pharmacokinetics of single and multiple ascending doses of the drug.

What clinical trials is AZD4916 in?

AZD4916 is being studied in one active Phase 1 clinical trial, registered under the identifier NCT06951880. The trial is titled 'A Study to Investigate the Safety and Pharmacokinetics of Single- and Multiple-ascending Doses of AZD4916 in Healthy Volunteers' and is recruiting participants in the United States and United Kingdom.

Is AZD4916 being studied in healthy volunteers?

Yes, AZD4916 is being studied in healthy volunteers. The Phase 1 clinical trial NCT06951880 is a placebo-controlled study enrolling 160 healthy participants aged 18 years and older. The trial is randomized but not double-blinded, and it is currently recruiting in the United States and United Kingdom.