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NCT02125435 · ClinicalTrials.gov registry record · Phase 1

A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects

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

Completed
Registry status
Phase 1
Development phase
65
Enrollment target

NCT02125435: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.

NCT02125435 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02125435, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.

COMPLETED
Registry status
Phase 1
Development phase
65 participants
Enrollment target

Study Summary

The objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous (IV) doses of ASP2408 in non-elderly, healthy male and female subjects and to evaluate the pharmacodynamics of ASP2408.

Primary Outcome

Area Under the Concentration - Time curve from time 0 up to the last quantifiable concentration (AUClast)

Interventions

  • DRUG Placebo
  • DRUG ASP2408

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2011-01
Est. Completion 2012-05
Phase Phase 1
Astellas Pharma Global Development

168 total trials

What the finished NCT02125435 record still lists

NCT02125435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

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

NCT02125435 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02125435 about?

NCT02125435 is a clinical study titled "A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects". The objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous (IV) doses of ASP2408 in non-elderly, healthy male and female subjects and to evaluate the pharmacodynamics of ASP2408.

What is the current status of trial NCT02125435?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2011-01. Estimated completion is 2012-05.

What interventions are being tested in trial NCT02125435?

The interventions under investigation include: Placebo (DRUG), ASP2408 (DRUG).

Who is sponsoring clinical trial NCT02125435?

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 NCT02125435's enrollment target sits among peer trials

65 798th of 2000 higher than 1,193 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 NCT02125435, the US trial registry maintained by the National Library of Medicine. NCT02125435 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.