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NCT04588727 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AZD3366 in Healthy Subjects, Japanese and Chinese Subjects
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 103
- Enrollment target
NCT04588727: Completed Phase 1 study, sponsored by AstraZeneca.
NCT04588727 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 103 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04588727, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 103 participants
- Enrollment target
Study 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).
Primary Outcome
Adverse events will be assessed to investigate the safety and tolerability of intravenous administration of AZD3366 in healthy subjects, healthy Japanese subjects and healthy Chinese subjects.
Interventions
- DRUG Placebo
- DRUG Ticagrelor
- DRUG acetylsalicylic acid (ASA)
- DRUG AZD3366
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2020-10-15 |
| Est. Completion | 2022-01-19 |
| Phase | Phase 1 |
What the finished NCT04588727 record still lists
NCT04588727 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04588727 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04588727 about?
NCT04588727 is a clinical study titled "Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AZD3366 in Healthy Subjects, Japanese and Chinese Subjects". 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...
What is the current status of trial NCT04588727?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 103 participants. The study started on 2020-10-15. Estimated completion is 2022-01-19.
What interventions are being tested in trial NCT04588727?
The interventions under investigation include: Placebo (DRUG), Ticagrelor (DRUG), acetylsalicylic acid (ASA) (DRUG), AZD3366 (DRUG).
Who is sponsoring clinical trial NCT04588727?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04588727's enrollment target sits among peer trials
103 541st of 2000 higher than 1,458 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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