Status:
TERMINATED
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6615 in Healthy Subjects
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Dyslipidemia
Eligibility:
All Genders
20-60 years
Phase:
PHASE1
Brief Summary
This study will be a randomized, single-blind, placebo-controlled, single-ascending dose (SAD), sequential group study. It is a SAD study in healthy Non-Asian subjects (Part 1) and healthy Japanese su...
Detailed Description
This study part is planned to consist of 3 cohorts of Non-Asian subjects (Part 1) and 2 cohorts of Japanese subjects (Part 2). Part 2 will be initiated no earlier than after completion of the last Saf...
Eligibility Criteria
Inclusion
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit, must not be lactating and must be of non-child-bearing potential.
- Provision of signed, written and dated informed consent for optional genetic research.
- 4: In Part 1: Healthy male and/or female Non-Asian subjects aged 20 - 60 years (inclusive at Screening Visit) with suitable veins for cannulation or repeated venipuncture. In Part 2: Healthy male and/or female Japanese subjects aged 20 - 60 years (inclusive at Screening Visit) with suitable veins for cannulation or repeated venipuncture.
- 5\. Have a body mass index between 18 and 30 kg/m\^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive at the Screening Visit and Day -1.
- 6\. Males should avoid fathering a child by either true abstinence or a highly effective contraception form of birth control during the study.
Exclusion
- History of any clinically important 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.
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Subjects with known autoimmune disease or on treatment with immune-modulatory drugs.
- Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational medicinal product.
- Any laboratory values with the following deviations at the Screening Visit and/or Day -1, test may be repeated once for each visit at the discretion of the Investigator if out of range: (Alanine aminotransferase \> upper limit of normal \[ULN\], Aspartate aminotransferase \> ULN, Creatinine \> ULN, White blood cell count \< 3.5 x 10\^9/L, Hb \< lower limit of normal \[LLN\], Platelet count \<LLN).
- Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus.
- Abnormal vital signs, any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities in the 12-Lead ECG as considered by the Investigator, that may interfere with the interpretation of QTc interval changes.
- Known or suspected history of drug abuse, current smoker or those who have smoked or used nicotine products within the previous 3 months before the Screening Visit.
- History of alcohol abuse and/or severe allergy/hypersensitivity.
- Previous bone marrow transplant.
- Males who are unwilling to use an acceptable method of birth control during the entire study period.
Key Trial Info
Start Date :
July 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04055168
Start Date
July 24 2019
End Date
February 10 2020
Last Update
December 14 2020
Active Locations (2)
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1
Research Site
Glendale, California, United States, 91206
2
Research Site
Baltimore, Maryland, United States, 21225