AZD5423 Multiple Ascending Dose Study

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AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Placebo
Drug: AZD5423

Study type

Interventional

Funder types

Industry

Identifiers

NCT01037504
D2340C00002
EudraCT No: 2009-016611-38

Details and patient eligibility

About

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following multiple ascending dose administrations in healthy male and female subjects

Enrollment

27 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Provision of signed and dated, written informed consent prior to any study specific procedures
  • Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion criteria

  • Any clinically significant disease or disorder
  • Any clinically significant abnormalities at screening examination
  • Use of any prescribed or non-prescribed medication

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

27 participants in 2 patient groups, including a placebo group

A
Experimental group
Description:
Drug: AZD5423
Treatment:
Drug: AZD5423
B
Placebo Comparator group
Description:
Drug: Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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