AZD8848 Single Ascending Dose Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-07-31

Brief Summary

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This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of AZD8848 in healthy subjects.

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Detailed Description

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A Double-blind, Placebo-controlled, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD8848 in Healthy Subjects

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AZD8848

Group Type EXPERIMENTAL

AZD8848

Intervention Type DRUG

Single dose, oral inhalation (nebuliser solution)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose, oral inhalation (nebuliser solution)

Interventions

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AZD8848

Single dose, oral inhalation (nebuliser solution)

Intervention Type DRUG

Placebo

Single dose, oral inhalation (nebuliser solution)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy men or women aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
* Women can be of childbearing potential and must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 (screening) and be willing to continue on the chosen contraceptive method
* Male subjects should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the day of the investigational product administration until 3 months
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Ability to produce sputum of good enough quality for assessment of biomarkers

Exclusion Criteria

* Abnormal vital signs, after 10 minutes supine rest, defined as any of the following (SBP \> 140 mmHg, Diastolic blood pressure (DBP) \> 90 mmHg, Heart rate \< 40 or \> 85 beats per minute)
* Prolonged QTcF \> 450 ms or shortened QTcF \< 340 ms or family history of long QT syndrome
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class as AZD8848
* History of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT syndrome, or sudden death)
* History of asthma or allergic rhinitis

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes