Trials / Completed
CompletedNCT03899142
Pharmacokinetics of New HepBQuin
Pharmacokinetics of HepBQuin Manufactured According to a New Production Process
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Prothya Biosolutions · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | a human hepatitis B immunoglobulin solution for injection for intramuscular administration | intramuscular administration |
Timeline
- Start date
- 2019-03-20
- Primary completion
- 2019-07-04
- Completion
- 2019-07-04
- First posted
- 2019-04-02
- Last updated
- 2019-09-19
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03899142. Inclusion in this directory is not an endorsement.