Pure Global
NCT04588727

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
AstraZeneca·Phase 1·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Cardiovascular Disease
Drug/Device/Intervention
AZD3366
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
AstraZeneca
Location
Glendale, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Oct 15, 2020
End date
May 20, 2022
Enrollment
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, unspecifiedHypertensive heart diseaseHeart disease, unspecifiedAtherosclerotic cardiovascular disease, so describedAtherosclerotic heart disease
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04588727
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.