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AZD7295

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Jul 23, 2009

AZD7295 development status

Highest phase Phase 1
Registered trials 2 across 2 sponsors since Jan 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment62

FDA Designations

No designations recorded

AZD7295 clinical trials

AZD7295 · 1 trial · 1 indication

Phase 1 1
NCT00818129Study to Investigate Safety, Tolerability and PK Following Single and Multiple Ascending Doses of AZD7295 in JapaneseHealthy Subjects
COMPLETED62 Analytics
PHASE1COMPLETED
Study to Investigate Safety, Tolerability and PK Following Single and Multiple Ascending Doses of AZD7295 in Japanese
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

AE, safety laboratory test (haematology, clinical chemistry, urinalysis), 12-lead ECG, BP, pulse rate, body temperature
During the study

Secondary Endpoints

Pharmacokinetics (Cmax, tmax, AUC, AUC0-t, CL/F, Vss/F, t1/2 , Cmin, Rac, etc)
Frequent sampling until 72 hours after single administration in Single Dose Part and until 72 hours after last administration (6 days administration) in Multiple Dose Part
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AZD7295DRUGascending single doses (start dose 90 mg), oral solution and then multiple ascending dose (tbd based on single dose results), oral solution
PlaceboDRUGmultiple ascending dose (tbd based on single dose results), oral solution
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Eligibility Criteria

Age Range20 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed, written and dated informed consent * Healthy male Japanese volunteers aged 20-55 years * BMI between 18 and 27 kg/m2 * Have negative screens for HIV, hepatitis B and C viruses and syphilis Exclusion Criteria: * Use of prescribed medication within 2 weeks...

Countries:Japan
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Frequently asked questions about AZD7295

What is AZD7295?

AZD7295 is an investigational small molecule drug developed by AstraZeneca PLC. It has been studied in a Phase 1 clinical trial in healthy Japanese male subjects. The specific disease or condition it is intended to treat has not been disclosed.

Who is developing AZD7295?

AZD7295 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the Phase 1 trial of the compound conducted in Japan.

What phase is AZD7295 in?

AZD7295 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.

What clinical trials is AZD7295 in?

AZD7295 has been evaluated in one completed Phase 1 trial, NCT00818129, titled a study to investigate safety, tolerability and pharmacokinetics following single and multiple ascending doses in Japanese subjects. The trial enrolled 62 healthy male volunteers in Japan and was placebo-controlled, randomized, and double-blind.

What was studied in the AZD7295 Phase 1 trial?

The Phase 1 trial NCT00818129 evaluated the safety, tolerability, and pharmacokinetics of AZD7295 after single and multiple ascending doses in healthy Japanese male subjects. It enrolled 62 participants, was randomized, double-blind, and placebo-controlled, and has been completed.