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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AZD3366 in Healthy Subjects, Japanese and Chinese Subjects - Trial NCT04588727

Access comprehensive clinical trial information for NCT04588727 through Pure Global AI's free database. This Phase 1 trial is sponsored by AstraZeneca and is currently Recruiting. The study focuses on Cardiovascular Disease. Target enrollment is 103 participants.

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NCT04588727
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT04588727
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AZD3366 in Healthy Subjects, Japanese and Chinese Subjects
A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3366 in Healthy Men and Women of Non-Childbearing Potential Following: Part A: Single Ascending Dose Administration (Including Populations of Japanese and Chinese Subjects) Part B: Single Dose Administration of AZD3366 at One Dose Level or Placebo With Concomitant Repeated Dosing of Ticagrelor and Acetylsalicylic Acid

Study Focus

Cardiovascular Disease

AZD3366

Interventional

drug

Sponsor & Location

AstraZeneca

Glendale, United States of America

Timeline & Enrollment

Phase 1

Oct 15, 2020

May 20, 2022

103 participants

Primary Outcome

Number of subjects with adverse events and serious adverse events in both Part A and Part B

Summary

Part A of this study is a Phase 1, First-in-human (FiH), randomized, single-blind, placebo
 controlled study to assess the safety, tolerability, pharmacokinetics (PK), and
 pharmacodynamics (PD) of AZD3366 following single intravenous (IV) ascending doses.
 
 Part B of this study is a randomized, single-blind, parallel group placebo-controlled study
 to assess the safety, tolerability and PD of a single IV administration of AZD3366 with
 concomitant loading doses followed by repeated maintenance dosing of ticagrelor and
 acetylsalicylic acid (ASA).

ICD-10 Classifications

Cardiovascular disease, unspecified
Hypertensive heart disease
Heart disease, unspecified
Atherosclerotic cardiovascular disease, so described
Atherosclerotic heart disease

Data Source

ClinicalTrials.gov

NCT04588727

Non-Device Trial