Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human) (GamaSTAN)
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|ClinicalTrials.gov Identifier: NCT03351933|
Recruitment Status : Completed
First Posted : November 24, 2017
Last Update Posted : September 24, 2018
This is a single center, open-label, single-arm study in which approximately 28 Hepatitis A virus (HAV)-seronegative healthy subjects will be enrolled. There will be a screening period of up to 28 days during which subjects will be screened for enrollment in the study.
Healthy subjects will receive 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 will be assessed up to 60 days after the administration of GamaSTAN. A PK curve will be obtained during the PK sampling period.
|Condition or disease||Intervention/treatment||Phase|
|Anti-Hepatitis A Antibody Levels in Heathy Subjects||Biological: Immune Globulin (Human)||Phase 4|
This is a single center, open-label, single-arm study design, in which approximately 28 subjects will receive the same study treatment (0.2 mL/kg dose via IM injection). There is no reference therapy in this study.
The study will be explained to each subject prior to the subject providing written informed consent. All subjects will be screened to ensure that all the inclusion criteria and none of the exclusion criteria are met.
A sufficient number of healthy male and female subjects will be qualified by screening assessments and procedures for reporting to the clinical site on Day -1. The healthy subjects will receive a single IM dose of GamaSTAN (0.2 mL/kg) on Day 1. Subjects will be discharged from the clinic on Day 2, following the scheduled assessments and procedures, and will return 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 complete the study will be approximately 178 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 31, 2017|
|Actual Primary Completion Date :||April 27, 2018|
|Actual Study Completion Date :||July 19, 2018|
Experimental: Immune Globulin (Human) GamaSTAN
The healthy subjects will receive a single IM dose of GamaSTAN (0.2 mL/kg), followed by a PK sampling period of 150 days.
Biological: Immune Globulin (Human)
A single 0.2 mL/kg IM injection of Immune Globulin (Human) (GamaSTAN) will be administered in healthy subjects.
Other Name: GamaSTAN
- Percentage of subjects maintaining protective anti- HAV antibody levels [ Time Frame: Day 60 ]Percentage of subjects maintaining anti-HAV antibody levels ≥10 mIU/mL up to Day 60 following study treatment administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351933
|United States, Kansas|
|Vince & Associates Clinical Research, Inc.|
|Overland Park, Kansas, United States, 66212|