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NCT03593785 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8233 in Healthy Male Subjects With Increased Elevated LDL-C Levels.

A Phase 1 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 1
Development phase
73
Enrollment target

NCT03593785: Completed Phase 1 study, sponsored by AstraZeneca.

NCT03593785 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 73 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03593785, a Phase 1 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 1
Development phase
73 participants
Enrollment target

Study Summary

AZD8233 has not been evaluated in clinical studies previously. This is a first-in-human (FiH) study. This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD8233, following subcutaneous (SC) administration of single ascending dose (SAD) of AZD8233. This study will also investigate the pharmacodynamics (PD) of AZD8233 by investigating the effect of AZD8233 on levels of cholesterol and related biomarkers.

Primary Outcome

To assess AEs as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses. Serious AEs will be recorded from the time of informed consent.

Interventions

  • DRUG AZD8233

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2018-08-03
Est. Completion 2020-12-19
Phase Phase 1
AstraZeneca

1,285 total trials

What the finished NCT03593785 record still lists

NCT03593785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher).

The record links to 0 conditions, and to 1 intervention - of which AZD8233 is the first listed.

NCT03593785 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03593785 about?

NCT03593785 is a clinical study titled "A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8233 in Healthy Male Subjects With Increased Elevated LDL-C Levels.". AZD8233 has not been evaluated in clinical studies previously. This is a first-in-human (FiH) study. This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD8233, following subcutaneous (SC) administration of single ascending dose (SAD) of AZD8233. This study will also invest...

What is the current status of trial NCT03593785?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2018-08-03. Estimated completion is 2020-12-19.

What interventions are being tested in trial NCT03593785?

The interventions under investigation include: AZD8233 (DRUG).

Who is sponsoring clinical trial NCT03593785?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03593785's enrollment target sits among peer trials

73 732nd of 2000 higher than 1,265 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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Source: ClinicalTrials.gov NCT03593785, the US trial registry maintained by the National Library of Medicine. NCT03593785 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.