Pharmacokinetics of New HepBQuin

Pharmacokinetics of HepBQuin Manufactured According to a New Production Process

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: a human hepatitis B immunoglobulin solution for injection for intramuscular administration

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Mannheim, Germany
    • CRS Clinical Research Services Mannheim GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: human hepatitis B immunoglobulin; once, i.m.	Biological: a human hepatitis B immunoglobulin solution for injection for intramuscular administration; intramuscular administration

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Prothya Biosolutions

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2019
• Primary Completion (ACTUAL): July 4, 2019
• Study Completion (ACTUAL): July 4, 2019

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (ACTUAL): April 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous
• Other Study ID Numbers: MD2017.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No