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OpenTrials
Completed

NCT Number: NCT02246855

A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg in Healthy Volunteers

The main object of the study is to compare the AUC0-84, of a single intravenous infusion of Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up to 3mL/min and up to 6mL/min).

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Key information

Conditions

Healthy

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Research Unit (CPRU)

Level 7, Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy, normotensive, non-smoking male and female volunteers aged 18 to 60 who gave written informed consent and fulfilled all of the inclusion criteria and none of the exclusion criteria.
  • Female volunteers of childbearing potential had a negative pregnancy test before entering the study and had to use either a double barrier method of contraception or use the oral contraceptive pill.
  • Postmenopausal or surgically sterile female volunteers could be enrolled.

Exclusion criteria

-

Treatment and study plan

Gammaplex® (Human Normal Immunoglobulin)

Biological

Primary outcomes

  1. PK parameters for serum immunoglobulin G (IgG)

    Time frame: Screening, pre-dose (Day 1), 15 min, 4 hr, 24 hr, 30 hr, 48 hr, Days 4, 8, 11, 15, 18, 22, 29, 36, 43, 50, 57, 71, 85

Sponsors and collaborators

Lead sponsor

Bio Products Laboratory

Other

Registry information

Official study title

A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg (Vigam® Liquid and Gammaplex®) Using Standard and Accelerated Infusion Rates in Healthy Adult Volunteers (Three Treatment Arms)

Important dates

Study start
2004
Primary completion
2004
First posted
Sep 23, 2014
Registry last updated
Feb 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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