CompletedPhase 1

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

United Kingdom44 participantsStarted 2013-07

Plain-language summary

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

Who can participate

Age range18 Years – 50 Years

SexALL

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Inclusion criteria

✓. 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 )
✓. 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
✓. 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

✕. 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
✕. Current smokers or those who have smoked or used nicotine products within the previous 3 months
✕.Clinically significant lower respiratory tract infection not resolved within 4 weeks prior to Visit 1, as determined by the Investigator

What they're measuring

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

Timeframe: From Screening to follow up ( maximum 7 weeks)

Trial details

NCT IDNCT01889160

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Safety,Plasma AUC and Cmax, Plasma AUC 0-t, t1/2λz, and Tmax trials