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

NCT03351933 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-07-30

Study results available
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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.

Conditions

  • Anti-Hepatitis A Antibody Levels in Heathy Subjects

Interventions

BIOLOGICAL

Immune Globulin (Human)

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

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2018-04-27
Completion
2018-07-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03351933 on ClinicalTrials.gov