Pharmacokinetics of New HepBQuin

Study Overview
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Brief Summary
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Sanquin Plasma Products BV developed a new manufacturing process for the Quin plasma products in order to improve viral safety and to remove procoagulant activity. Since the new manufacturing process will be the same for all Quin products, a clinical study with one of the Quin products is sufficient for marketing authorisation of all new Quin products. HepBQuin will serve as model for all other Quin products. Pharmacokinetic (PK) data are considered as a surrogate indicator of efficacy.

Official Title
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Pharmacokinetics of HepBQuin Manufactured According to a New Production Process

Conditions
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Healthy

Intervention / Treatment
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* Biological: a human hepatitis B immunoglobulin solution for injection for intramuscular administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers, male and female, aged 18 to 65 inclusive. Negative serology test for HBsAg, anti-HBs, and anti-HBc at screening. Body-mass index (BMI) of 18.5 to 32.0 kg/m2 (inclusive). Female volunteers must have a pregnancy test at screening. Willing to participate by signing the written signed informed consent form. Exclusion Criteria: Vaccinated against Hepatitis B Having a Hepatitis B infection or suffered from a Hepatitis B infection in the past. Known with allergic reactions against human plasma, plasma products or blood products. A history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening. Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections. Known with or having a history of arterial or venous thromboembolic events. Pre-existing risk factors for thrombotic events. Any clinically significant history of or current clinically significant other disease or disorder. Any clinically significant abnormality following the investigator's review of physical examination, and clinical laboratory tests obtained at screening. An abnormal pulse rate and/or blood pressure measurements at the screening visit. Pregnant or breast-feeding at screening or at Day 0 Women of childbearing potential not using a highly effective method of birth. Any use of drugs or abuse within 3 months prior to screening and during study. Alcohol abuse within 3 months prior to screening and during study Participated in another interventional clinical trial a month before the start of the study, or having received an experimental drug during the previous 30 days. Having IgA deficiency with anti-IgA antibodies. Blood or plasma donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: human hepatitis B immunoglobulin<br>once, i.m. | Biological: a human hepatitis B immunoglobulin solution for injection for intramuscular administration<br>* intramuscular administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| half-life of anti-HBs antibodies | Pharmacokinetics | 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of adverse events | Safety | 84 days |