Study to Investigate Safety, Tolerability and Pharmacokinetics With Single and Multiple Ascending Doses of AZD1446

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: AZD1446

Study type: Interventional

Funder types: Industry

Identifiers

NCT00902993

D1950C00002

EudraCT No. 2008-008389-10

Details and patient eligibility

About

This study is designed to evaluate the safety, tolerability and PK of AZD1446 in Subjects when given as multiple dose administration for either 7 Days (Day 1 single dose, Day 2-6 multiple doses) in Part A and optionally at fractionated doses for 1 Day in Part B.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or non-fertile female, young or elderly Subjects, aged ≥18 to ≤50 or ≥65 to ≤80
• Body mass index (BMI) between 19 and 30 kg/m2
• Clinically normal findings on physical examination

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

80 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Part A single and multiple dose and part B fractionated dose

Treatment:

Drug: AZD1446

2

Placebo Comparator group

Treatment:

Drug: Placebo