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

Bio Products Laboratory

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Biological: Gammaplex® (Human Normal Immunoglobulin)

Study type

Interventional

Funder types

Other

Identifiers

NCT02246855

GMX03

Details and patient eligibility

About

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).

Sex

All

Volunteers

Accepts Healthy Volunteers

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