A Study of AZD4205 in Healthy Adult Subjects

Dizal Pharmaceuticals66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

AZD4205DRUG

SAD: 5mg, 20mg, 50mg, 100mg and 150mg MAD: low, medium and high dose once daily X14 days

PlaceboDRUG

Single dose in SAD and once daily for 14 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Frontage clinical service

Secaucus, New Jersey, United States

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)

Data from ClinicalTrials.gov

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