AZD2423 Single Ascending Dose Study in Healthy Japanese Subjects (JSAD)

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: AZD2423

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00970775

D2600C00003

Details and patient eligibility

About

This is a Phase I, single centre, randomised, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability and pharmacokinetics of AZD2423 following single ascending dose administration to healthy Japanese subjects.

Enrollment

32 patients

Sex

All

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy Japanese male and non-fertile female subjects aged ≥20 to ≤55 years with suitable veins for cannulation or repeated venepuncture.
Body weight 45-90 kg and Body mass index (BMI) ≥18.0 and ≤27.0 kg/m2
Clinically normal physical findings including supine blood pressure, pulse rate, orthostatic blood pressure, ECG, and laboratory assessments in relation to age, as judged by the Investigator.

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.
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.
Frequent use of tobacco or other nicotine containing products. Frequent use is defined as smoking or consumption/intake of nicotine products more than two days per week during the last 12 weeks.