A Study of AZD4205 in Healthy Adult Subjects

Study Overview
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Brief Summary
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This study is to assess the safety, tolerability, pharmacokinetics of AZD4205 following single and multiple ascending dose in healthy adult subjects, and to assess the effect of food on the pharmacokinetics of AZD4205.

Official Title
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A Phase I, Randomized, Double Blind, Placebo Controlled 2-Parts Study to Assess the Safety, Tolerability, Pharmacokinetics of AZD4205 Following Single and Multiple Ascending Dose in Healthy Adult Subjects, and to Assess the Effect of Food on the Pharmacokinetics of AZD4205

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: AZD4205
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be able to understand the nature of the trial and provide a signed and dated, written informed consent form prior to any study specific procedures, sampling and analyses. Female and/or male aged ≥18   ≤ 45 years, with BMI ≥18 ≤ 28kg/m2. Female subjects must have negative pregnancy tests at screening and check-in AND: have been surgically sterile OR post-menopausal OR, if of child-bearing potential, must be using an acceptable method of contraception. Male subjects must be surgically sterile or using an acceptable method of contraception during the study and for 6 months after the last dose of AZD4205 or matching placebo to prevent pregnancy with a partner. Exclusion Criteria: Evidence or reported history of clinically significant hematological (absolute neutrophil count < 1.5 x 10^3/μL; platelet count < 100 x 10^3/μL; hemoglobin < 9 g/dL, INR > 1.5), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease determined by the investigator. Infections Received a live vaccine within 3 months before first dose of IP.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD4205<br>Single ascending dose: 5mg, 20mg, 50mg, 100mg, 150mg Multiple ascending dose: low, medium and high dose once daily X 14 days | Drug: AZD4205<br>* SAD: 5mg, 20mg, 50mg, 100mg and 150mg MAD: low, medium and high dose once daily X14 days<br>|
| Placebo Comparator: Placebo<br>placebo single dose in SAD and once daily for 14 days | Drug: Placebo<br>* Single dose in SAD and once daily for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects with adverse events | To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of adverse events (AEs) | From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD) | 
| The number of subjects with abnormal laboratory parameters | To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal laboratory parameters | From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD) | 
| The number of subjects with abnormal vital signs | To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal vital signs | From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD) | 
| The number of subjects with abnormal electrocardiogram | To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal electrocardiogram | From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD) |