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AZD5122

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Dec 4, 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

Clinical trial landscape

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
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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 used for?

AZD5122 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in early clinical development. The only completed trial evaluated a single dose in healthy male subjects to investigate its activity and safety.

Who makes AZD5122?

AZD5122 is being developed by AstraZeneca PLC, which trades on the stock exchange under the ticker AZN. The company sponsored the Phase 1 clinical trial of this investigational small molecule.

What phase is AZD5122 in?

AZD5122 is in Phase 1 clinical development. The single Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities, and its safety and efficacy have not been established.

What clinical trials is AZD5122 in?

AZD5122 has one completed clinical trial, registered as NCT00984477. This Phase 1 study investigated the activity of a single dose of AZD5122 in healthy male subjects aged 18 years and older in the United Kingdom. The trial enrolled 100 participants and was placebo-controlled and double-blind.

Is AZD5122 the same as any other drug?

No alternative names for AZD5122 have been disclosed. The drug is identified only by its code name AZD5122 in the clinical trial registry, and no other brand or chemical names have been reported.