A Single and Multiple Ascending Dose Study With AZD9164 Given for 13 Days in Healthy Male and Female Japanese Subjects

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD9164 After Administration of Single and Multiple Ascending Doses for 13 Days in Healthy Male and Female Japanese Subjects

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01096563

Acronym

JSMAD

Enrollment

Registered

2010-03-31

Start date

2010-03-31

Completion date

2010-06-30

Last updated

2010-12-03

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

Conditions

Healthy

Keywords

Phase I, Japanese healthy volunteer, AZD9164

Brief summary

This is a single centre, Double blinded, Randomised, Placebo-controlled, Parallel group study to access the safety, tolerability, and pharmacokinetics of Inhaled AZD9164 after administration of single and Multiple Ascending doses in Japanese subjects.

Interventions

DRUGAZD9164

Dry powder for inhalation via Turbuhaler, JSMAD. A single dose of AZD9164 on Day 1 and repeated dosing on Day 4 to day 15 (JSMAD). The starting dose will be 400 μg delivered dose and subsequent doses are planned to be 1000 μg and 2800 μg delivered dose.

DRUGPlacebo

Dry powder for inhalation via Turbuhaler, JSMAD.

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 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Japanese subjects with suitable veins for cannulation or repeated venipuncture * Have a body mass index (BMI) between 18 and 27 kg/m2 and a body weight between 50 and 85 kg * Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product

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, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product

Design outcomes

Primary

Measure	Time frame
Safety measurements (ECG's, Telemetry, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)	Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study

Secondary

Measure	Time frame
To investigate the pharmacokinetics (PK) of AZD9164 following inhaled administration of single and multiple ascending doses, by assessment of the dose proportionality, the degree of accumulation and the time linearity	PK sampling during the residential period and intense PK sampling on day 1 and day 15 (up to 72 and 120 hours respectively)
To investigate pharmacodynamic (PD) effects of inhaled single and multiple ascending doses of AZD9164, by assessment of lung function	Spirometry during the residential stay on days 1, 4, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026