Pharmacokinetics of New HepBQuin

NCT03899142 | Completed Phase 1

• 1 other identifier: MD2017.01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• half-life of anti-HBs antibodies

  Pharmacokinetics

  84 days

Secondary Outcomes (1)

• number of adverse events

  84 days

Study Arms (1)

human hepatitis B immunoglobulin

EXPERIMENTAL

once, i.m.

Biological: a human hepatitis B immunoglobulin solution for injection for intramuscular administration

Interventions

a human hepatitis B immunoglobulin solution for injection for intramuscular administration BIOLOGICAL

intramuscular administration

human hepatitis B immunoglobulin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prothya Biosolutions: lead

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, Germany

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 2, 2019
• Study Start: March 20, 2019
• Primary Completion: July 4, 2019
• Study Completion: July 4, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)