A First Time in Man Study to Asses the Safety and Tolerability of AZD7624 in Healthy Subjects

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Drug: AZD7624

Drug: Placebo to match

Study type

Interventional

Funder types

Industry

Identifiers

NCT01754844

D2550C00001

Details and patient eligibility

About

This is a First in Human study to assess the safety and tolerability of AZD7624, following inhaled administration of single ascending doses in healthy male volunteers and female volunteers of non-child bearing potential. Pharmacokinetics (what the body does to the drug) and pharmacodynamic (what the drug does to the body) parameters will be also assessed as secondary objectives.

Full description

A Double-blind Placebo-controlled, Randomised, Single centre, First Time in Man Study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD7624 in Healthy Subjects

Enrollment

57 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male and/or female subjects aged 18 to 55 years
Able to inhale from the SPIRA nebuliser according to the provided instructions
Females must have a negative pregnancy test at screening and on admission (Day 1) to the CPU, must not be lactating and must be of non-childbearing potential.
Body mass index (BMI) between 18 and 30 kg/m2 inclusive and weighing at least 50 kg and no more than 100 kg inclusive.
FEV1 >80% of the predicted normal value.

Exclusion criteria

History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7624
History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
History or family history of muscle diseases
Known or suspected history of drug abuse as judged by the Investigator
Use of any prescribed or non-prescribed medication including antacids, analgesics other than paracetamol/acetaminophen, herbal remedies, vitamins (excluding routine vitamins but including megadose [intake of 20 to 600 times the recommended daily dose])