Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)

Summary

This was a single center, open-label, single-arm study in which approximately 28 Hepatitis A virus (HAV)-seronegative healthy subjects were enrolled. There was a screening period of up to 28 days during which subjects were screened for enrollment in the study. Healthy subjects received a single intramuscular (IM) dose of GamaSTAN (0.2 mL/kg), followed by a pharmacokinetic (PK) sampling period of 150 days (approximately 5 half-lives). The protective levels of anti-HAV antibodies were assessed up to 60 days after the administration of GamaSTAN. A PK curve was obtained during the PK sampling period.

Timeline

Start

2017-10-31

Primary completion

2018-04-27

Completion

2018-07-19

Publications

• Kankam M, Griffin R, Price J, Michaud J, Liang W, Llorens MB, Sanz A, Vince B, Vilardell D. Polyvalent Human Immune Globulin: A Prospective, Open-Label Study Assessing Anti-Hepatitis A Virus (HAV) Antibody Levels, Pharmacokinetics, and Safety in HAV-Seronegative Healthy Subjects. Adv Ther. 2020 May;37(5):2373-2389. doi: 10.1007/s12325-020-01327-9. Epub 2020 Apr 16.

Drugs

Indications

No indication recorded.