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NCT02074800 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Safety and Pharmacokinetics of a Single Intravenous Administration of CNTO 328 Derived From 2 Different Cell Lines in Healthy Participants

A Phase 1 study of Healthy, sponsored by Centocor.

Completed
Registry status
Phase 1
Development phase
145
Enrollment target
2
Study locations

NCT02074800 is a Phase 1 study of Healthy that has completed, run by Centocor. The registered enrollment target is 145 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT02074800, a Phase 1 study of Healthy, has completed, sponsored by Centocor.

COMPLETED
Registry status
Phase 1
Development phase
145 participants
Enrollment target
2
Study locations

Study Summary

The purpose of Part 1 of this study is to assess the safety and tolerability of 2 dose levels (1.4 and 2.8 mg/kg) of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328. The purpose of Part 2 of this study is to access the pharmacokinetics (what the body does to the study medication) comparability of the 1.4 mg/kg dose of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328.

Conditions Studied

Healthy

Interventions

  • DRUG Placebo
  • DRUG CNTO 328 (Sp2/0-derived)
  • DRUG CNTO 328 (CHO-derived)

Study Locations (2)

Nebraska

  • - Lincoln

New Jersey

  • - Neptune City

Trial Details

FieldValue
Enrollment Target 145 participants
Start Date 2008-06
Est. Completion 2009-06
Phase Phase 1

Sponsor

Centocor

33 total trials

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What the Registry Record Tells You About NCT02074800

The ClinicalTrials.gov registry entry for NCT02074800 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (78% lower). The listed sponsor is Centocor, which has 33 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT02074800 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Nebraska, New Jersey.

Frequently Asked Questions

What is clinical trial NCT02074800 about?

NCT02074800 is a clinical study titled "A Study to Assess the Safety and Pharmacokinetics of a Single Intravenous Administration of CNTO 328 Derived From 2 Different Cell Lines in Healthy Participants". The purpose of Part 1 of this study is to assess the safety and tolerability of 2 dose levels (1.4 and 2.8 mg/kg) of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328. The purpose of Part 2 of this study is to access the pharmacokinetics (what the body does to the study medication) comparability of th...

What is the current status of trial NCT02074800?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 145 participants. The study started on 2008-06. Estimated completion is 2009-06.

What conditions does trial NCT02074800 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT02074800?

The interventions under investigation include: Placebo (DRUG), CNTO 328 (Sp2/0-derived) (DRUG), CNTO 328 (CHO-derived) (DRUG).

Who is sponsoring clinical trial NCT02074800?

This trial is sponsored by Centocor, which has 33 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02074800 being conducted?

This trial has 2 study locations across Nebraska, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.