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AZD6423

Phase 1

Healthy Volunteers. | Small molecule | Other |AstraZeneca PLC|Last Updated: Apr 4, 2014

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

Clinical trial landscape

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
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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 used for?

AZD6423 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in Phase 1 clinical development. The completed trial evaluated the drug in healthy participants to assess its safety and tolerability.

Who makes AZD6423?

AZD6423 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker AZN. The company sponsored the Phase 1 clinical trial of this investigational small molecule.

What phase is AZD6423 in?

AZD6423 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The single Phase 1 trial has been completed, and the drug is not yet available for clinical use.

What clinical trials is AZD6423 in?

AZD6423 has one completed Phase 1 trial, identified as NCT01926366, titled 'AZD6423 SAD/MAD Study in Healthy Volunteers.' The study enrolled 175 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is AZD6423 FDA approved?

AZD6423 is not FDA approved. It is an investigational drug in Phase 1 clinical development. The completed trial in healthy volunteers was designed to evaluate safety and tolerability, but the drug has not been approved for any medical use.