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AZD6423

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Apr 4, 2014

AZD6423 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment175

FDA Designations

No designations recorded

AZD6423 clinical trials

AZD6423 · 1 trial · 1 indication

Phase 1 1
NCT01926366AZD6423 SAD/MAD Study in Healthy VolunteersHealthy Volunteers.
COMPLETED175 Analytics
PHASE1COMPLETED
AZD6423 SAD/MAD Study in Healthy Volunteers
Healthy Volunteers.Unlock trial analytics

Study Endpoints

Primary Endpoints

Assessment of the safety and tolerability of AZD6423 in healthy subjects via adverse events
From Baseline up to 18 days

The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.

Assessment of the safety and tolerability of AZD6423 in healthy subjects via EEG
From Baseline up to 6 days

The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.

Assessment of the safety and tolerability of AZD6423 in healthy subjects via ECG.
From Baseline up to 18 days

The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.

Assessment of the safety and tolerability of AZD6423 in healthy subjects via vital signs (blood pressure and pulse). as well as body temperature and weight
From Baseline up to 18 days

The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.

Assessment of the safety and tolerability of AZD6423 in healthy subjects via clinical laboratory tests (chemistry, hematology and urinalysis).
From Baseline up to 18 days

The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.

Assessment of the safety and tolerability of AZD6423 in healthy subjects via psychiatric assessments.
From Baseline up to 18 days

The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.

Assessment of the safety and tolerability of AZD6423 in healthy subjects via neurological exams.
From Baseline up to 18 days

The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.

Assessment of the safety and tolerability of AZD6423 in healthy subjects via physical exams.
From Baseline up to 18 days

The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.

Secondary Endpoints

Description of the PK profile for AZD6423 in terms of: observed maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal rate constant (λz), terminal half-life (t½ z), and area under the curve (AUC).
From Baseline up to 7 days
Assessment of the pharmacodynamics of AZD6423 in terms of the relationship between plasma concentration of AZD6423 and EEG
From Baseline up to 7 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Experimental: AZD6423EXPERIMENTALSubjects will participate in 1 of 8 groups and receive single or multiple doses of AZD6423 or matching placebo. In each group 6 subjects will receive AZD6423 and 2 subjects will receive matching placebo.
Placebo to match AZD6423PLACEBO_COMPARATORSubjects will participate in 1 of 8 groups and receive single or multiple doses of AZD6423 or matching placebo. In each group 6 subjects will receive AZD6423 and 2 subjects will receive matching placebo.

Interventions

NameTypeDescription
AZD6423DRUGDrug: AZD6423 Single or Multiple doses via infusion.
PlaceboDRUGPlacebo to match AZD6423 Single or Multiple doses of matching placebo delivered via infusion
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Eligibility Criteria

SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Subjects must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-specific procedures. 2. All male subjects who are biologically capable of having children must agre...

Countries:United States
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Frequently asked questions about AZD6423

What is AZD6423?

AZD6423 is an investigational small molecule developed by AstraZeneca PLC. It has been studied in a Phase 1 clinical trial in healthy volunteers. The specific disease or condition it is intended to treat has not been disclosed, and the program is in early-stage clinical development.

Who makes AZD6423?

AZD6423 is made and developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the Phase 1 study conducted for this compound.

What phase is AZD6423 in?

AZD6423 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. Because only early-stage testing has been conducted, AZD6423 is investigational and has not been approved by the FDA for any indication.

What clinical trials has AZD6423 been studied in?

AZD6423 was evaluated in a single Phase 1 trial, NCT01926366, titled AZD6423 SAD/MAD Study in Healthy Volunteers. The trial was a randomized, double-blind, placebo-controlled study that enrolled 175 healthy adult volunteers in the United States and has been completed.

How was the AZD6423 Phase 1 trial designed?

The AZD6423 Phase 1 trial, NCT01926366, used a single ascending dose and multiple ascending dose design. It was randomized, double-blind, and placebo-controlled, enrolling 175 healthy volunteers of all sexes in the United States. The study has been completed.