Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers

A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Single Ascending Dose Study to Asses the Safety, Tolerability, Pharmacokinetics of AZD1446 Including an Open Food Effect Panel in Healthy Male and Non-Fertile Female Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00803855

Acronym

SAD

Enrollment

110

Registered

2008-12-08

Start date

2008-12-31

Completion date

2009-04-30

Last updated

2009-05-15

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

Conditions

Healthy

Keywords

single dose, pharmacokinetics, safety, healthy volunteers, food interaction, AZD1446

Brief summary

The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration.

Interventions

DRUGAZD1446

oral, single dose

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* physical healthy volunteers * weight between 50 to 100 kg and a body mass index (BMI) between 19 and 30 kg/m2

Exclusion criteria

* History of any clinically significant disease or disorder. * History of severe allergy/hypersensitivity reactions

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables	From first to last visit

Secondary

Measure	Time frame
Determine the single ascending dose pharmacokinetics of AZD1446	PK sampling taken at defined timepoints during residential period
Determine the single dose of AZD1446 on food interaction	From first to last visit

Countries

Sweden

Outcome results

None listed

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