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Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 in Healthy Volunteers (SAD)

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: AZD2423
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00940212
D2600C00001
EudraCT 2009-010364-42

Details and patient eligibility

About

The primary aim of this study is to investigate the safety and tolerability of AZD2423 single doses in healthy volunteers.

Enrollment

80 patients

Sex

All

Ages

20 to 55 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, as calculated by the investigator, and weigh at least 50 kg and no more than 100 kg
  • Healthy male and non-fertile female volunteers with suitable veins for cannulation or repeated venipuncture

Exclusion criteria

  • History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study,or influence the results or the subject's ability to participate in the study
  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
  • Any clinically significant illness/infection or medical/surgical procedure or trauma,as judged by the Principal Investigator, within 3 months of the first administration of investigational product

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

A
Experimental group
Description:
AZD2423
Treatment:
Drug: AZD2423
B
Experimental group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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