Anti-Hepatitis A Antibody Levels in Heathy Subjects Clinical Trial
Official title:
A Prospective, Open-Label, Single-Arm Clinical Trial to Assess the Anti-Hepatitis A Virus (HAV) Antibody Levels, Pharmacokinetics, and Safety of a Single Intramuscular Dose of a Polyvalent Human Immune Globulin in HAV Seronegative Healthy Subjects
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.
This was a single center, open-label, single-arm study design, in which approximately 28
subjects received the same study treatment (0.2 mL/kg dose via IM injection). There was no
reference therapy in this study.
The study was explained to each subject prior to the subject providing written informed
consent. All subjects were screened to ensure that all the inclusion criteria and none of the
exclusion criteria were met.
A sufficient number of healthy male and female subjects were qualified by screening
assessments and procedures for reporting to the clinical site on Day -1. The healthy subjects
received a single IM dose of GamaSTAN (0.2 mL/kg) on Day 1. Subjects were discharged from the
clinic on Day 2, following the scheduled assessments and procedures, and returned to the
clinical site for the remaining ambulatory PK samples and safety monitoring, and again for
the final visit (Day 150).
The total duration of study participation for subjects who completed the study were
approximately 178 days.
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