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NCT01554800 · ClinicalTrials.gov registry record · Phase 1

Effect of ACP-501 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Subjects With Coronary Artery Disease

A Phase 1 study, sponsored by MedImmune.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT01554800: Completed Phase 1 study, sponsored by MedImmune.

NCT01554800 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01554800, a Phase 1 study, has completed, sponsored by MedImmune.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

This study is a phase 1, intravenous, open-label, single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-501 (recombinant human Lecithin Cholesterol Acyl Transferase (rhLCAT)) in subjects with coronary artery disease (CAD). Four cohorts consisting of 4 subjects each will receive one dose of ACP-501. The dose will be escalated by cohort.

Primary Outcome

Safety and tolerability of a single dose of ACP-501 as determined by adverse event reporting, clinical laboratory results, vital signs, physical examination, and electrocardiograms (ECGs).

Interventions

  • DRUG ACP-501

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2012-03
Est. Completion 2012-09
Phase Phase 1
MedImmune

210 total trials

What the finished NCT01554800 record still lists

NCT01554800 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 1 intervention - of which ACP-501 is the first listed.

NCT01554800 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01554800 about?

NCT01554800 is a clinical study titled "Effect of ACP-501 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Subjects With Coronary Artery Disease". This study is a phase 1, intravenous, open-label, single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-501 (recombinant human Lecithin Cholesterol Acyl Transferase (rhLCAT)) in subjects with coronary artery disease (CAD). Four cohorts consis...

What is the current status of trial NCT01554800?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2012-03. Estimated completion is 2012-09.

What interventions are being tested in trial NCT01554800?

The interventions under investigation include: ACP-501 (DRUG).

Who is sponsoring clinical trial NCT01554800?

This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01554800's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 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 NCT01554800, the US trial registry maintained by the National Library of Medicine. NCT01554800 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.