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

AstraZeneca110 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

110

Conditions

Healthy

Interventions

AZD1446DRUG

oral, single dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research site

Huddinge, Sweden

Outcomes

Primary Outcomes

Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables

Time frame: From first to last visit

Secondary Outcomes

Determine the single ascending dose pharmacokinetics of AZD1446

Time frame: PK sampling taken at defined timepoints during residential period

Determine the single dose of AZD1446 on food interaction

Time frame: From first to last visit

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.