PRA-170071

Autoimmune diseases

Study of a new formulation of a registered drug that is being developed for the treatment of autoimmune diseases

Besonderheiten (auf Englisch)

  • For this study we are looking for healthy males, between 18 and 55 years old who do not smoke.
  • Your Body Mass Index (BMI) is between 19 and 29.9 kg/m2 and your body weight is between 50 – 99.9 kg. The BMI shows the relation between body weight in kilograms and height in meters.
  • You have not participated in any other drug study within 90 days preceding the medical screening.
  • You did not participate in one of the following studies with PRA code: 120711, 134391, 166721, 142461 and 164911.
  • To determine if you are eligible to participate in this study, you will undergo a medical screening. Based on the availability this can be done in Utrecht or Groningen.
BMI berechnen

Vergütung (auf Englisch)

You will receive a gross compensation of € 3.056,- for complete participation in one of the groups of this study.  


Travelling expenses will be reimbursed based on the distance traveled (€ 0.19 net per kilometer) with a minimum of € 12,- and a maximum of € 160,- (840 kilometers) per return, regardless of the mode of transportation. After the first period of this study you will receive a payment of your travel expenses so far.

 

Please note: For this study it is possible to receive an interim payment of € 1,000 after the fifth short visit. You will receive the remaining € 1,912 after completing the entire study.

Periode und Studie (auf Englisch)

The study consists of 2 periods. For each period you will stay in our research facility in Groningen (location Martini) for 7 days (6 nights). The first period will be followed by 5 short visits and the second period by 6 short visits.

In case it is necessary, we can arrange overnight stays between the period of stay and the short visits or between the short visits for this study. For example, it is possible to stay 5 days in Groningen in a B&B / hotel between the 1st and 3rd and / or the 6th and 8th short visit. This can be coordinated in consultation.

Please note: You can find the dates of each group below on our website. If these dates are not possible for you we can check if there are other options for you to participate in this study. 

Sonstige Information (auf Englisch)

Type of study

Soon, a research study will start at PRA with a new formulation of a registered study drug that is being developed for the treatment of autoimmune diseases (for example for rheumatoid arthritis and psoriasis). This study will compare the study drug to a similar product which is already on the market in US referred to as comparator drug. The study drug and the comparator drug contain the same active ingredient.

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. The study drug is no new drug; it is already available on the market in several dosages as a pre filled syringe, but not in a dose-adjustable vial for injection (e.g. for paediatric patients who weigh less than 63 kilograms). The other already registered drug is already available as dose-adjustable vial for injection in the treatment of autoimmune diseases in children.  This study will be performed in 56 healthy male volunteers.

The study will only take place after it has been approved by the Independent Ethics Committee.

Setup and duration of the study

To determine if you are suitable to participate in this study, you will undergo a medical screening visit.

Following the screening visit, if you are eligible for participation, the study consists of 2 periods in which you will stay in our research facility in Groningen (location Martini) for 7 days (6 nights) for each period. The first period will be followed by 5 short visits and the second period by 6 short visits.

You have to be available for all dates for this group to be able to participate in this study. The dates of the study will be published on our website www.praclinicaltrials.com. These are the currently planned dates; however, these may be subject to change.

Blood samples will be taken regularly during the study.

During the study, you will receive the study drug and the registered drug as an injection under the skin (subcutaneous) of your abdomen. The order in which you will receive the study drug and the registered drug will be determined by chance. Between the two dosing’s a wash-out of at least 35 days is necessary.

Risks and medical supervision

All drugs can potentially cause adverse reactions; the extent to which this occurs differs. The most common known side effects of the study drug and the comparator drug include the following:

Very common (may affect more than 1 in 10 people):
Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections);
Injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling).
Reactions at the injection site (these do not occur as often after the first month of treatment). Some patients have developed a reaction at an injection site that was used before.

Common (may affect up to 1 in 10 people):
Allergic reactions; fever; itching; antibodies directed against normal tissue (autoantibody formation).
More information about the more uncommon side effects can be found in the Informed Consent Form that can be found in the package leaflet which will be handed out to you before and during the screening for this study.
You should be aware that the adverse events mentioned above and possibly other, still unknown, adverse events may occur during the study.
You will be under strict medical supervision during the study.

During the last short visit of period 2, you will have the follow-up visit.

Conditions for participation

You are a healthy male between 18 and 55 years old. You are only allowed to participate if you do not smoke. Your Body Mass Index (BMI) is between 19 and 29.9 kg/m2 and your body weight is between 50 – 99.9 kg. The BMI shows the relation between body weight in kilograms and height in meters.

You did not participate in one of the following studies with PRA code: 120711, 134391, 166721, 142461, and 164911.

The study will be done under standardized conditions. Use of alcohol, poppy seeds and tobacco products during the study is not allowed. Also before the study there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine is allowed. Before you are allowed to take part in the study, you will be medically screened. During this screening, the study doctor will discuss with you if any of the medications you were or you are still using could prevent you from participating in the study

Registrieren Sie sich unverbindlich für eine der unten aufgeführten Studiengruppen

Groep 52

2 × 7 Tage Aufenthalt

  • 28 Jan 2020 bis einschl. 3 Feb 2020
  • 4 Mär 2020 bis einschl. 10 Mär 2020

kurzer Besuch

  • 5 Feb 2020
  • 7 Feb 2020
  • 9 Feb 2020
  • 12 Feb 2020
  • 16 Feb 2020
  • 12 Mär 2020
  • 14 Mär 2020
  • 16 Mär 2020
  • 19 Mär 2020
  • 23 Mär 2020
  • 2 Apr 2020

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 3.056,- Wählen

Group 58

2 × 7 Tage Aufenthalt

  • 28 Jan 2020 bis einschl. 3 Feb 2020
  • 4 Mär 2020 bis einschl. 10 Mär 2020

kurzer Besuch

  • 5 Feb 2020
  • 7 Feb 2020
  • 9 Feb 2020
  • 12 Feb 2020
  • 16 Feb 2020
  • 12 Mär 2020
  • 14 Mär 2020
  • 16 Mär 2020
  • 19 Mär 2020
  • 23 Mär 2020
  • 2 Apr 2020

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 3.056,- Wählen

Group 59

2 × 7 Tage Aufenthalt

  • 28 Jan 2020 bis einschl. 3 Feb 2020
  • 4 Mär 2020 bis einschl. 10 Mär 2020

kurzer Besuch

  • 5 Feb 2020
  • 7 Feb 2020
  • 9 Feb 2020
  • 12 Feb 2020
  • 16 Feb 2020
  • 12 Mär 2020
  • 14 Mär 2020
  • 16 Mär 2020
  • 19 Mär 2020
  • 23 Mär 2020
  • 2 Apr 2020

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 3.056,- Wählen

Group 60

2 × 7 Tage Aufenthalt

  • 28 Jan 2020 bis einschl. 3 Feb 2020
  • 4 Mär 2020 bis einschl. 10 Mär 2020

kurzer Besuch

  • 5 Feb 2020
  • 7 Feb 2020
  • 9 Feb 2020
  • 12 Feb 2020
  • 16 Feb 2020
  • 12 Mär 2020
  • 14 Mär 2020
  • 16 Mär 2020
  • 19 Mär 2020
  • 23 Mär 2020
  • 2 Apr 2020

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 3.056,- Wählen
Volle Studien anzeigen

Groep 1

Voll
€ 2.912,- Wählen

Groep 2

Voll
€ 2.912,- Wählen

Groep 3

Voll
€ 2.912,- Wählen

Groep 4

Voll
€ 2.912,- Wählen

Groep 5

Voll
€ 2.912,- Wählen

Groep 6

Voll
€ 2.912,- Wählen

Groep 7

Voll
€ 2.912,- Wählen

Group 8

Voll
€ 2.912,- Wählen

Group 9

Voll
€ 2.912,- Wählen

Group 10

Voll
€ 2.912,- Wählen

Group 11

Voll
€ 2.912,- Wählen

Group 13

Voll
€ 2.912,- Wählen

Group 14

Voll
€ 2.912,- Wählen

Group 16

Voll
€ 2.912,- Wählen

Group 17

Voll
€ 2.912,- Wählen

Groep 18

Voll
€ 2.912,- Wählen

Group 19

Voll
€ 2.912,- Wählen

Group 20

Voll
€ 2.912,- Wählen

Group 21

Voll
€ 2.912,- Wählen

Group 22

Voll
€ 2.912,- Wählen

Group 23

Voll
€ 2.912,- Wählen

Group 24

Voll
€ 2.912,- Wählen

Group 25

Voll

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 2.912,- Wählen

Group 26

Voll

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 2.912,- Wählen

Group 27

Voll

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 2.912,- Wählen

Group 28

Voll

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 2.912,- Wählen

Group 29

Voll

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 2.912,- Wählen

Group 30

Voll

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 2.912,- Wählen

Group 31

Voll

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 2.912,- Wählen

Group 32

Voll

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 2.912,- Wählen

Group 33

Voll

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 2.912,- Wählen

Group 34

Voll

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 2.912,- Wählen

Group 35

Voll

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 2.912,- Wählen

Group 36

Voll

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 2.912,- Wählen

Group 37

Voll

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 2.912,- Wählen

Group 38

Voll

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 2.912,- Wählen

Group 39

Voll

2 × 7 Tage Aufenthalt

  • 8 Dez 2019 bis einschl. 14 Dez 2019
  • 13 Jan 2020 bis einschl. 19 Jan 2020

kurzer Besuch

  • 16 Dez 2019
  • 18 Dez 2019
  • 20 Dez 2019
  • 23 Dez 2019
  • 27 Dez 2019
  • 21 Jan 2020
  • 23 Jan 2020
  • 25 Jan 2020
  • 28 Jan 2020
  • 1 Feb 2020
  • 11 Feb 2020

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 3.056,- Wählen

Group 40

Voll

2 × 7 Tage Aufenthalt

  • 12 Dez 2019 bis einschl. 18 Dez 2019
  • 17 Jan 2020 bis einschl. 23 Jan 2020

kurzer Besuch

  • 20 Dez 2019
  • 22 Dez 2019
  • 24 Dez 2019
  • 27 Dez 2019
  • 31 Dez 2019
  • 25 Jan 2020
  • 27 Jan 2020
  • 29 Jan 2020
  • 1 Feb 2020
  • 5 Feb 2020
  • 15 Feb 2020

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 3.056,- Wählen

Group 42

Voll

2 × 7 Tage Aufenthalt

  • 16 Dez 2019 bis einschl. 22 Dez 2019
  • 21 Jan 2020 bis einschl. 27 Jan 2020

kurzer Besuch

  • 24 Dez 2019
  • 26 Dez 2019
  • 28 Dez 2019
  • 31 Dez 2019
  • 4 Jan 2020
  • 29 Jan 2020
  • 31 Jan 2020
  • 2 Feb 2020
  • 5 Feb 2020
  • 9 Feb 2020
  • 19 Feb 2020

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 3.056,- Wählen

Group 43

Voll

2 × 7 Tage Aufenthalt

  • 23 Dez 2019 bis einschl. 29 Dez 2019
  • 28 Jan 2020 bis einschl. 3 Feb 2020

kurzer Besuch

  • 31 Dez 2019
  • 2 Jan 2020
  • 4 Jan 2020
  • 7 Jan 2020
  • 11 Jan 2020
  • 5 Feb 2020
  • 7 Feb 2020
  • 9 Feb 2020
  • 12 Feb 2020
  • 16 Feb 2020
  • 26 Feb 2020

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 3.056,- Wählen

Group 44

Voll

2 × 7 Tage Aufenthalt

  • 29 Dez 2019 bis einschl. 4 Jan 2020
  • 3 Feb 2020 bis einschl. 9 Feb 2020

kurzer Besuch

  • 6 Jan 2020
  • 8 Jan 2020
  • 10 Jan 2020
  • 13 Jan 2020
  • 17 Jan 2020
  • 11 Feb 2020
  • 13 Feb 2020
  • 15 Feb 2020
  • 18 Feb 2020
  • 22 Feb 2020
  • 3 Mär 2020

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 3.056,- Wählen

Group 45

Voll

2 × 7 Tage Aufenthalt

  • 6 Jan 2020 bis einschl. 12 Jan 2020
  • 11 Feb 2020 bis einschl. 17 Feb 2020

kurzer Besuch

  • 14 Jan 2020
  • 16 Jan 2020
  • 18 Jan 2020
  • 21 Jan 2020
  • 25 Jan 2020
  • 19 Feb 2020
  • 21 Feb 2020
  • 23 Feb 2020
  • 26 Feb 2020
  • 1 Mär 2020
  • 11 Mär 2020

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 3.056,- Wählen

Group 46

Voll

2 × 7 Tage Aufenthalt

  • 8 Jan 2020 bis einschl. 14 Jan 2020
  • 13 Feb 2020 bis einschl. 19 Feb 2020

kurzer Besuch

  • 16 Jan 2020
  • 18 Jan 2020
  • 20 Jan 2020
  • 23 Jan 2020
  • 27 Jan 2020
  • 21 Feb 2020
  • 23 Feb 2020
  • 25 Feb 2020
  • 28 Feb 2020
  • 3 Mär 2020
  • 13 Mär 2020

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 3.056,- Wählen

Group 47

Voll

2 × 7 Tage Aufenthalt

  • 12 Jan 2020 bis einschl. 18 Jan 2020
  • 17 Feb 2020 bis einschl. 23 Feb 2020

kurzer Besuch

  • 20 Jan 2020
  • 22 Jan 2020
  • 24 Jan 2020
  • 27 Jan 2020
  • 31 Jan 2020
  • 25 Feb 2020
  • 27 Feb 2020
  • 29 Feb 2020
  • 3 Mär 2020
  • 7 Mär 2020
  • 17 Mär 2020

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 3.056,- Wählen

Group 48

Voll

2 × 7 Tage Aufenthalt

  • 14 Jan 2020 bis einschl. 20 Jan 2020
  • 19 Feb 2020 bis einschl. 25 Feb 2020

kurzer Besuch

  • 22 Jan 2020
  • 24 Jan 2020
  • 26 Jan 2020
  • 29 Jan 2020
  • 2 Feb 2020
  • 27 Feb 2020
  • 29 Feb 2020
  • 2 Mär 2020
  • 5 Mär 2020
  • 9 Mär 2020
  • 19 Mär 2020

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 3.056,- Wählen

Group 49

Voll

2 × 7 Tage Aufenthalt

  • 19 Jan 2020 bis einschl. 25 Jan 2020
  • 24 Feb 2020 bis einschl. 1 Mär 2020

kurzer Besuch

  • 27 Jan 2020
  • 29 Jan 2020
  • 31 Jan 2020
  • 3 Feb 2020
  • 7 Feb 2020
  • 3 Mär 2020
  • 5 Mär 2020
  • 7 Mär 2020
  • 10 Mär 2020
  • 14 Mär 2020
  • 24 Mär 2020

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 3.056,- Wählen

Group 50

Voll

2 × 7 Tage Aufenthalt

  • 21 Jan 2020 bis einschl. 27 Jan 2020
  • 26 Feb 2020 bis einschl. 3 Mär 2020

kurzer Besuch

  • 29 Jan 2020
  • 31 Jan 2020
  • 2 Feb 2020
  • 5 Feb 2020
  • 9 Feb 2020
  • 5 Mär 2020
  • 7 Mär 2020
  • 9 Mär 2020
  • 12 Mär 2020
  • 16 Mär 2020
  • 26 Mär 2020

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 3.056,- Wählen

Group 51

Voll

2 × 7 Tage Aufenthalt

  • 26 Jan 2020 bis einschl. 1 Feb 2020
  • 2 Mär 2020 bis einschl. 8 Mär 2020

kurzer Besuch

  • 3 Feb 2020
  • 5 Feb 2020
  • 7 Feb 2020
  • 10 Feb 2020
  • 14 Feb 2020
  • 10 Mär 2020
  • 12 Mär 2020
  • 14 Mär 2020
  • 17 Mär 2020
  • 21 Mär 2020
  • 31 Mär 2020

Opnametype

If these dates are not possible for you we can check if there are other options to participate in this study.

€ 3.056,- Wählen