A Study of AZD4205 in Healthy Adult Subjects (JACKPOT2)

Dizal Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: AZD4205

Study type: Interventional

Funder types: Industry

Identifiers

NCT03728023

DZ2018J0001

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 2 patient groups, including a placebo group

AZD4205

Experimental group

Description:

Single ascending dose: 5mg, 20mg, 50mg, 100mg, 150mg Multiple ascending dose: low, medium and high dose once daily X 14 days

Treatment:

Drug: AZD4205

Placebo

Placebo Comparator group

Description:

placebo single dose in SAD and once daily for 14 days

Treatment:

Drug: Placebo