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AZD5122

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Dec 4, 2009

AZD5122 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

AZD5122 clinical trials

AZD5122 · 1 trial · 1 indication

Phase 1 1
NCT00984477Study to Investigate the Activity of AZD5122 When Given as a Single Dose to Healthy Male SubjectsHealthy
COMPLETED100 Analytics
PHASE1COMPLETED
Study to Investigate the Activity of AZD5122 When Given as a Single Dose to Healthy Male Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetic profile: concentration of AZD5122 in blood
Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.

Secondary Endpoints

Pharmacokinetic profile: concentration of AZD5122 in urine
Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
Measurement of the effect of AZD5122 on circulating neutrophils
Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
Pharmacodynamic profile: assessment of various pharmacodynamic measures
Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 48 hours post-dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTALAZD5122 oral suspension (part A and B)
2PLACEBO_COMPARATORPlacebo oral suspension (part A)
3EXPERIMENTALAZD5122 oral and IV infusion (part B)

Interventions

NameTypeDescription
AZD5122DRUGA single dose of oral suspension
PlaceboDRUGA single dose of oral suspension
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Eligibility Criteria

Age Range18 Years to 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed and dated, written informed consent. * Normal physical examination, laboratory values, blood pressure and pulse * Healthy male caucasian subjects Exclusion Criteria: * Subjects must not have any history of gastrointestinal, hepatic or renal disease, or an...

Countries:United Kingdom
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Frequently asked questions about AZD5122

What is AZD5122?

AZD5122 is an investigational small molecule being developed by AstraZeneca PLC. It has been studied in a Phase 1 clinical trial involving healthy male volunteers. The specific therapeutic indication for AZD5122 has not been disclosed.

Who is developing AZD5122?

AZD5122 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is a global biopharmaceutical company headquartered in the United Kingdom.

What phase is AZD5122 in?

AZD5122 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA.

What clinical trials is AZD5122 in?

AZD5122 has been evaluated in a single Phase 1 trial, NCT00984477, titled "Study to Investigate the Activity of AZD5122 When Given as a Single Dose to Healthy Male Subjects." The trial was completed and enrolled 100 healthy male participants in the United Kingdom.

What is AZD5122 used for?

The therapeutic use of AZD5122 has not been disclosed. It has been tested only in healthy volunteers in a Phase 1 trial, so no specific disease indication has been publicly identified for this investigational small molecule.