AZD2423 Single Ascending Dose Study in Healthy Japanese Subjects

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 After Single Ascending Doses in Healthy Japanese Male and Non-Fertile Female Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00970775

Acronym

JSAD

Enrollment

Registered

2009-09-02

Start date

2009-08-31

Completion date

2009-12-31

Last updated

2010-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Phase I, Japanese healthy volunteer, AZD2423

Brief summary

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.

Interventions

DRUGAZD2423

oral solution, single dose

DRUGPlacebo

oral solution,single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
To asses the safety: Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables.	From screening period to follow-up visit, 40 days (Maximum).

Secondary

Measure	Time frame
To characterize the pharmacokinetics of AZD2423 in plasma and urine.	Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately)
Exploratory endpoints;Levels of CCL2 pre-and post dose	Blood sampling after dosing, 3 days

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026