AZD8529 Single Ascending Dose Study in Healthy Japanese Subjects (JSAD)
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Drug: AZD8529
Drug: Placebo
Details and patient eligibility
About
This is a Phase I, double-blind, placebo-controlled, randomised within each dose group, single ascending dose study, with the objective to assess the safety, tolerability and pharmacokinetic profile of AZD8529 in healthy Japanese subjects.
Enrollment
48 estimated patients
Sex
Male
Ages
20 to 45 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Healthy male Japanese subjects aged 20 to 45 years (inclusive)
- Have a body mass index (BMI) between 18 and 27 kg/m 2 (inclusive) and weigh at least 50 kg.least 50 kg.
Exclusion criteria
- History of any clinically significant 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.
- Any clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, haematology or urinalysis as judged by the Investigator and/or Sponsor.
- Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1.
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
48 participants in 2 patient groups, including a placebo group
1
Experimental group
Treatment:
Drug: AZD8529
2
Placebo Comparator group
Treatment:
Drug: Placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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