A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6615 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-24

Study Completion Date

2020-02-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 subjects (Part 2) to assess the safety and tolerability of AZD6615 and to characterize the pharmacokinetics (PK) of AZD6615.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 Safety Review Committee (SRC) review in Part 1. Healthy male and/or female subjects aged 20 to 60 years will be included in both Parts 1 and 2 of the study. Female subjects must be of non-childbearing potential. Study Part 1 is planned to be conducted in 24 subjects but may be conducted in up to 40 subjects. Study Part 2 is planned to be conducted in 16 subjects but may be conducted in up to 32 subjects.

Within each cohort of Parts 1 and 2, 6 subjects will be randomized to receive AZD6615 and 2 subjects will be randomized to receive placebo. Dosing and food intake should be supervised and documented by study staff when subjects are in the clinic.

The study will comprise of:

* A Screening Period of maximum 28 days.
* A Dosing Session during which subjects will be resident at the Clinical Unit from the day before IMP administration (Day -1) until at least 78 hours after Investigational medicinal product (IMP) administration; discharged on Day 4.
* A Follow-Up Period of 12 weeks that will consist of 6 Follow-Up Visits, for which the subjects will return to the Clinical Unit at 2, 4, 6, 8, 10, and 12 weeks post-dose.

Within each cohort, site personnel remain blinded until the SRC meeting.

Following review of the data, the SRC may also decide to adjust the following for subsequent cohorts:

* The time window between the sentinel dose group and the main dose group in Part 1.
* The length of the stay at the study site, the timing and number of assessments and/or samples.
* The length of the follow-up period.
* The length of the data collection period for the SRC review.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyslipidemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Dyslipidemia Single Ascending Dose Safety Tolerability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Intervention Type DRUG

Placebo (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD6615

AZD6615 (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects.

Intervention Type DRUG

Placebo

Placebo (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Study drug Control

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Provision of signed and dated, written informed consent prior to any study specific procedures.
2. 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.
3. 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 Criteria

1. 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.
2. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
3. Subjects with known autoimmune disease or on treatment with immune-modulatory drugs.
4. Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational medicinal product.
5. 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).
6. Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus.
7. 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.
8. 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.
9. History of alcohol abuse and/or severe allergy/hypersensitivity.
10. Previous bone marrow transplant.
11. Males who are unwilling to use an acceptable method of birth control during the entire study period.

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Han, MD

Role: PRINCIPAL_INVESTIGATOR

California Clinical Trials Medical Group

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Glendale, California, United States

Site Status

Research Site

Baltimore, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Makhmudova U, Steinhagen-Thiessen E, Volpe M, Landmesser U. Advances in nucleic acid-targeted therapies for cardiovascular disease prevention. Cardiovasc Res. 2024 Sep 2;120(10):1107-1125. doi: 10.1093/cvr/cvae136.

Reference Type DERIVED

PMID: 38970537 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D7991C00001

Identifier Type: -

Identifier Source: org_study_id

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6615 in Healthy Subjects

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Cohort 1 - Part 1

AZD6615

Placebo

Cohort 2 - Part 1

AZD6615

Placebo

Cohort 3 - Part 1

AZD6615

Placebo

Cohort 1 - Part 2

AZD6615

Placebo

Cohort 2 - Part 2

AZD6615

Placebo

Interventions

AZD6615

Placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Parexel

AstraZeneca

Responsible Party

Principal Investigators

David Han, MD

Locations

Research Site

Research Site

Countries

References

Makhmudova U, Steinhagen-Thiessen E, Volpe M, Landmesser U. Advances in nucleic acid-targeted therapies for cardiovascular disease prevention. Cardiovasc Res. 2024 Sep 2;120(10):1107-1125. doi: 10.1093/cvr/cvae136.

Other Identifiers

D7991C00001