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NCT01565681 · ClinicalTrials.gov registry record · Phase 1

Study of ASKP1240 After a Single Intravenous Dose at Escalating Dose Levels in Healthy Subjects

A Phase 1 study, sponsored by Astellas Pharma Global Development.

Completed
Registry status
Phase 1
Development phase
109
Enrollment target

NCT01565681: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.

NCT01565681 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 109 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01565681, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.

COMPLETED
Registry status
Phase 1
Development phase
109 participants
Enrollment target

Study Summary

The objective of this study is to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of ASKP1240 after a single intravenous dose at escalating dose levels in healthy subjects.

Primary Outcome

binding of ASKP1240-biotin to B cells

Interventions

  • DRUG Placebo
  • DRUG ASP1240

Trial Details

FieldValue
Enrollment Target 109 participants
Start Date 2009-01
Est. Completion 2009-12
Phase Phase 1
Astellas Pharma Global Development

168 total trials

What the finished NCT01565681 record still lists

NCT01565681 is an interventional study that assigns participants to a tested intervention. The registered 109 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 (82% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01565681 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01565681 about?

NCT01565681 is a clinical study titled "Study of ASKP1240 After a Single Intravenous Dose at Escalating Dose Levels in Healthy Subjects". The objective of this study is to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of ASKP1240 after a single intravenous dose at escalating dose levels in healthy subjects.

What is the current status of trial NCT01565681?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 109 participants. The study started on 2009-01. Estimated completion is 2009-12.

What interventions are being tested in trial NCT01565681?

The interventions under investigation include: Placebo (DRUG), ASP1240 (DRUG).

Who is sponsoring clinical trial NCT01565681?

This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01565681's enrollment target sits among peer trials

109 522nd of 2000 higher than 1,478 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 NCT01565681, the US trial registry maintained by the National Library of Medicine. NCT01565681 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.