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AZD4916

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Sep 28, 2026

AZD4916 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2025

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

AZD4916 clinical trials

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)

LOWSep 28, 2026NCT06951880lastUpdatePostDate: changed
LOWSep 28, 2026NCT06951880lastUpdatePostDate: changed
LOWAug 26, 2026NCT06951880Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 26, 2026NCT06951880Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about AZD4916

What is AZD4916?

AZD4916 is an investigational small molecule drug being developed by AstraZeneca PLC. It is currently in Phase 1 clinical development, with one active trial evaluating it in healthy adult volunteers. The specific disease or condition it is intended to treat has not been disclosed.

Who is developing AZD4916?

AZD4916 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the Phase 1 clinical program for this investigational small molecule.

What phase is AZD4916 in?

AZD4916 is in Phase 1 clinical development. It has one active, recruiting Phase 1 trial and no completed trials. As an investigational drug, it has not been approved by the FDA and remains in early-stage clinical testing.

What clinical trials is AZD4916 in?

AZD4916 is being studied in one Phase 1 trial, NCT06951880, titled a study to investigate the safety and pharmacokinetics of single- and multiple-ascending doses of AZD4916 in healthy volunteers. The trial is recruiting, is placebo-controlled and randomized, and plans to enroll 160 participants in the United States and United Kingdom.

Who can participate in the AZD4916 clinical trial?

The Phase 1 trial NCT06951880 enrolls healthy adult volunteers aged 18 years and older, with no restriction by sex. It is a randomized, placebo-controlled study of single- and multiple-ascending doses, conducted at sites in the United States and the United Kingdom, with a planned enrollment of 160 participants.