The purpose of the study is to compare these two drugs in view of how quickly and to what extent the drugs are absorbed and eliminated from the body (this is called pharmacokinetics) after injection under the skin of the abdomen.In addition, it will…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To demonstrate PK similarity between Erelzi LYVI/US and Enbrel LYVI/US
following a single s.c. injection of 18 mg.
Secondary outcome
- To compare additional PK parameters between Erelzi LYVI/US and Enbrel LYVI/US
following a single s.c. injection
- To evaluate and compare the immunogenicity of both products
- To evaluate and compare the safety, tolerability and injection site reactions
(ISR) of both products
Background summary
This study will compare the study drug Erelzi powder to a similar product which
is already on the market in US, namely Enbrel® powder referred to as comparator
drug.
The study drug and the comparator drug contain the same active ingredient
called etanercept. Etanercept inhibits inflammatory reactions by binding to a
cytokine involved in inflammation, called TNF- (a cytokine is a small protein
involved in the communication between many different kinds of cells in the
human body).
Study objective
The purpose of the study is to compare these two drugs in view of how quickly
and to what extent the drugs are absorbed and eliminated from the body (this is
called pharmacokinetics) after injection under the skin of the abdomen.
In addition, it will be analysed to which degree the study drug is provoking an
immune response.
It will also be investigated how safe the study drug is and how well it is
tolerated after dosing.
This study is the first time that this new form of the study drug is being
given to humans.
Study design
The volunteers will arrive at the research center at 2 pm in the afternoon
prior to the administration of the research instrument (Day 1). The day that
the research drug is administered is called Day 1.
If the research physician has established that the volunteer is in good health
and there are no doubts about safety, then leave the research center after all
measurements on Day 6 have been completed. In both treatment periods one must
return five times for measurements in the research center on Days 8, 10, 12, 15
and 19.
During the study, one subcutaneous (under the skin) injection of 0.8 milliliter
(ml) (consisting of 18 milligrams [mg]) solution of the test or comparison
product into the abdomen is administered in each treatment period. This is a
so-called crossed study, which means that if one gets the research tool (Erelzi
solution) in Treatment Period 1, one gets the comparison product (Enbrel
solution) in Treatment Period 2, or vice versa. The order in which Erelzi and
Enbrel are awarded is determined by drawing lots, such as throwing a cup or
coin.
Intervention
Not applicable.
Study burden and risks
Pain, minor bleedings, bruises, possibly an infection.
Industriestrasse 25
Holzkirchen 83607
DE
Industriestrasse 25
Holzkirchen 83607
DE
Listed location countries
Age
Inclusion criteria
Male subjects
18 to 55 years, inclusive
Weight 50 - 99.9 kg
BMI 19.0 - 29.9 kg/m2 inclusive ;5. Subject is affiliated with social security or equivalent system
Exclusion criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-003828-76-NL |
| CCMO | NL66314.056.18 |