Study to Investigate the Safety Profile of AZD4721 After Single Doses at Different Dose Levels

AstraZeneca44 enrolled

Overview

Study to investigate the safety profile of AZD4721 after single doses at different dose levels

A study to investigate safety and tolerability of single ascending doses of AZD4721 given to healthy volunteers. Including a bioequivalence part to compare a solution of AZD4721 with a suspension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Safety,Plasma AUC and Cmax, Plasma AUC 0-t, t1/2λz, and Tmax

Interventions

AZD4721 SolutionDRUG

1-9 mg/mL liquid solution

AZD4721 PlaceboDRUG

Liquid solution

AZD4721 SuspensionDRUG

9 mg/g liquid suspension

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy male and/or female Caucasian (neither Black/African American nor Japanese) volunteers aged 18-50 years. ("Healthy" is as determined by medical history and physical examination, clinical laboratory parameters, and ECG ) 2. Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of nonchildbearing potential 3. Volunteers should have a BMI between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive). Exclusion Criteria: 1. History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate 2. Current smokers or those who have smoked or used nicotine products within the previous 3 months 2.Clinically significant lower respiratory tract infection not resolved within 4 weeks prior to Visit 1, as determined by the Investigator 4\. Other latent or chronic infections (eg, recurrent sinusitis, genital or ocular herpes, urinary tract infection) or at risk of infection (surgery, trauma, or significant infection) in previous 90 days, or history of skin abscesses within the previous

Locations (1)

Research Site

London, United Kingdom

Outcomes

Primary Outcomes

Description of the safety profile in terms of Adverse events; blood pressure, heart rate and body temperature; electrocardiograms; clinical chemistry; haematology assessments, including serial blood neutrophil count

Time frame: From Screening to follow up ( maximum 7 weeks)

Secondary Outcomes

Description of the pharmacokinetic(PK) profile for in terms of: observed maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal rate constant (λz), terminal half-life (t½ z).