At a glance
ClinicalIndex Comparison Record- ✓Male subjects 18–55 years or female subjects 18–65 years of age
- ✓BMI 18.5–29.9 kg/m² and body weight ≥50 kg
- ✓HAV seronegative (no anti-HAV antibodies)
- ✓No prior HAV vaccination
- ✕Prior immune globulin (IG) of any type within 12 months
- ✕History of hypersensitivity or allergic reaction to blood/plasma products
- ✕Known selective IgA deficiency (with or without antibodies to IgA)
- ✕Active tobacco smoking or ongoing diabetes mellitus
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Immune Globulin (Human) for Anti-Hepatitis A Antibody Levels in Heathy Subjects. Completed, enrolled 28 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
A single 0.2 mL/kg IM injection of Immune Globulin (Human) (GamaSTAN) was administered in healthy subjects.