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AZD7295

Phase 1

Healthy Subjects | Small molecule | Other |AstraZeneca PLC|Last Updated: Jul 23, 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

Clinical trial landscape

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 used for?

AZD7295 is an investigational small molecule being studied in healthy subjects. It is not approved for any disease and is in early clinical development. The completed Phase 1 trial evaluated its safety, tolerability, and pharmacokinetics in healthy Japanese male volunteers.

Who makes AZD7295?

AZD7295 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company sponsored the Phase 1 clinical trial of this investigational small molecule.

What phase is AZD7295 in?

AZD7295 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 no longer in active clinical testing.

What clinical trials is AZD7295 in?

AZD7295 has one completed Phase 1 trial, NCT00818129, which studied safety, tolerability, and pharmacokinetics following single and multiple ascending doses in healthy Japanese male subjects. The trial enrolled 62 participants and was placebo-controlled and double-blind.

Is AZD7295 the same as any other drug?

No alternative names for AZD7295 have been reported. It is identified by its code name AZD7295 in clinical trial records and is not known to be marketed under any other brand name.