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Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD8871 in Healthy Male Japanese Subjects

NCT03159442 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-10-25

No results posted yet for this study

Summary

AZD8871 is a new chemical entity possessing long-acting dual-pharmacology (muscarinic receptor antagonist and β2 adrenoceptor agonist \[MABA\]) in a single molecule. This type of agent presents a novel approach to the treatment of chronic obstructive pulmonary disease (COPD) and potentially asthma (in combination with an inhaled corticosteroid). AZD8871 is being developed for inhalation, formulated with alpha lactose monohydrate and delivered by dry powder inhaler (DPI) that allows delivery of a single dose of the study drug.

The primary objective is to investigate the safety and tolerability of AZD8871 at steady state in healthy male Japanese subjects.

Conditions

  • Chronic Obstructive Pulmonary Disease - COPD

Interventions

DRUG

AZD8871

Powder for inhalation administered via single dose DPI 300 and 600 µg/inhalation.

DRUG

Placebo

Powder for inhalation administered via single dose DPI

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Industrias Farmacéuticas Almirall S.A.

    collaborator UNKNOWN

  • The Doctors Laboratory Ltd

    collaborator INDUSTRY

  • Covance

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Muna Albayaty, MBChB, MSc, MFPM · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-19
Primary Completion
2017-10-13
Completion
2017-10-13

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03159442 on ClinicalTrials.gov