Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGAZD4205
SAD: 5mg, 20mg, 50mg, 100mg and 150mg MAD: low, medium and high dose once daily X14 days
DRUGPlacebo
Single dose in SAD and once daily for 14 days
Sponsors
Dizal Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Female and/or male aged ≥18 \ ≤ 45 years, with BMI ≥18\ ≤ 28kg/m2. 3. 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. 4. 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
1. 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. 2. Infections 3. Received a live vaccine within 3 months before first dose of IP.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of subjects with adverse events | From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD) | To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of adverse events (AEs) |
| The number of subjects with abnormal laboratory parameters | From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD) | To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal laboratory parameters |
| The number of subjects with abnormal vital signs | From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD) | To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal vital signs |
| The number of subjects with abnormal electrocardiogram | From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD) | To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal electrocardiogram |
Countries
United States
Outcome results
None listed