NCT03351933

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Grifols Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Anti-Hepatitis A Antibody Levels in Heathy Subjects

Interventions

Type	Name	Description
BIOLOGICAL	Immune Globulin (Human)	A single 0.2 mL/kg IM injection of Immune Globulin (Human) (GamaSTAN) was administered in healthy subjects.

Timeline

• Start date: 2017-10-31
• Primary completion: 2018-04-27
• Completion: 2018-07-19
• First posted: 2017-11-24
• Last updated: 2019-07-30
• Results posted: 2019-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study