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AZD6423

Phase 1

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

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment175
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01926366AZD6423 SAD/MAD Study in Healthy VolunteersPHASE1 COMPLETED 175 — — Sep 1, 2013Mar 1, 2014Apr 4, 20141 United States
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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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