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NCT00638989 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354

A Phase 1 study, sponsored by MedImmune.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT00638989: Completed Phase 1 study, sponsored by MedImmune.

NCT00638989 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00638989, a Phase 1 study, has completed, sponsored by MedImmune.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

To compare bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration compared with intravenous administration.

Primary Outcome

Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was assessed by the geometric least-square means ratios of subcutaneous to intravenous dose-normalized area under the serum concentration-time curve from time zero to infinity (AUC \[0 - infinity\]/Dose). AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time

Interventions

  • BIOLOGICAL CAT-354 150 mg (intravenous)
  • BIOLOGICAL CAT-354 150 mg (subcutaneous)
  • BIOLOGICAL CAT-354 300 mg (subcutaneous)

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2008-04-11
Est. Completion 2008-06-07
Phase Phase 1
MedImmune

210 total trials

What the finished NCT00638989 record still lists

NCT00638989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 3 interventions - of which CAT-354 150 mg (intravenous) is the first listed.

NCT00638989 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00638989 about?

NCT00638989 is a clinical study titled "A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354". To compare bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration compared with intravenous administration.

What is the current status of trial NCT00638989?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2008-04-11. Estimated completion is 2008-06-07.

What interventions are being tested in trial NCT00638989?

The interventions under investigation include: CAT-354 150 mg (intravenous) (BIOLOGICAL), CAT-354 150 mg (subcutaneous) (BIOLOGICAL), CAT-354 300 mg (subcutaneous) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00638989?

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

How this trial's enrollment target compares

Where NCT00638989's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 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 NCT00638989, the US trial registry maintained by the National Library of Medicine. NCT00638989 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.