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NCT02150070 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate a Single Intravenous (IV) Dose Using a New Manufactured Clone and Single Ascending Doses of Subcutaneous (SC) Injections
A Phase 1 study of Healthy Subjects and Pharmacokinetics of ASP2408, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT02150070: Completed Phase 1 study of Healthy Subjects and Pharmacokinetics of ASP2408, sponsored by Astellas Pharma Global Development.
NCT02150070 is a Phase 1 study of Healthy Subjects and Pharmacokinetics of ASP2408 that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 32 participants, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02150070, a Phase 1 study of Healthy Subjects and Pharmacokinetics of ASP2408, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) after intravenous (IV) administration of ASP2408 manufactured from a new production clone and also following single ascending doses of subcutaneous (SC) injections of the same clinical trial material.
Primary Outcome
Area under the concentration - Time curve from time 0 up to the last quantifiable concentration (AUClast)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ASP2408
Study Locations (1)
Maryland
- Parexel International - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
What the finished NCT02150070 record still lists
NCT02150070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (75% lower).
The record links to 2 conditions, with Healthy Subjects appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02150070 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02150070 about?
NCT02150070 is a clinical study titled "A Study to Evaluate a Single Intravenous (IV) Dose Using a New Manufactured Clone and Single Ascending Doses of Subcutaneous (SC) Injections". The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) after intravenous (IV) administration of ASP2408 manufactured from a new production clone and also following single ascending doses of subcutaneous (SC) injections of the same clinical trial material.
What is the current status of trial NCT02150070?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2011-08. Estimated completion is 2012-06.
What conditions does trial NCT02150070 study?
This clinical trial studies the following conditions: Healthy Subjects, Pharmacokinetics of ASP2408.
What interventions are being tested in trial NCT02150070?
The interventions under investigation include: Placebo (DRUG), ASP2408 (DRUG).
Who is sponsoring clinical trial NCT02150070?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02150070 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02150070's enrollment target sits among peer trials
32 35th of 69 higher than 33 of 69 other Healthy Subjects trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Subjects 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.
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