PRA-172541 Auto-immune diseases € 3.074,-

Full

Description

Study of a new compound that is being developed for the treatment of autoimmune diseases such as Rheumatoid Arthritis

Requested participants

  • M/F, healthy, 18 - 65 years old
  • Non-smokers only

Duration and visits

  • 21 days stay
  • 9 short visits afterwards

Learn more about this research?

Research details

Particulars

  • You do not smoke
  • Your body weight must be at least 50 kg and your Body Mass Index (BMI) is between 18.5 and 32 kg/m2. The BMI shows the relation between body weight in kilograms and length in meters.
  • Women are only allowed to participate in this study if they are willing to use sufficient contraception (e.g. hormonal contraceptives or intrauterine devices in combination with a condom) during the study, have been sterilized by hysterectomy for or have been postmenopausal for at least two years.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening.
Calculate BMI

Compensation

For your particpation in Part 2 (group 3 of 4) you will receive a gross compensation of € 3.074,- for participation in one of the above mentioned groups.

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.

Period of stay and research

For Part 1 the study consists of 1 period during which you will stay in our research facility in Groningen (location UMCG) for 4 days (3 nights), followed by 8 short visits to our research facility in Groningen (location Martini

For Part 2 the study consists of 6 periods during which you will stay in our research facility in Groningen (location UMCG). For three periods the clinical stay duration is 4 days (3 nights) and for three periods the clinical stay duration is 3 days (2 nights). In addition, period 1 and 4 will be followed by 1 short visit and period 6 will be followed by 7 short visits.

Please note: You have to be available for all dates for the group of choice to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.

Information sheet PRA-172541

Type of study

The study will be performed in 2 parts, Part 1 and 2. The purpose of the study is to investigate to what extent the study drug is tolerated. It will also be investigated how quickly and to what extent the study drug is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, the effect of the study drug on the immune system will be investigated (this is called pharmacodynamics).

The study drug is not registered as a drug but has been given to humans before. The study will only take place after it has been approved by the Independent Ethics Committee.

Setup and duration of the study

For Part 1, the study consists of 1 period during which you will stay in our research facility in Groningen (location UMCG) for 4 days (3 nights), followed by 8 short visits to our research facility in Groningen (location Martini). During this period you will receive the study drug or placebo once. A placebo is the same formulation without the active ingredient.

For Part 2, the study consists of 6 periods during which you will stay in our research facility in Groningen (location UMCG). For three periods the clinical stay duration is 4 days (3 nights) and for three periods the clinical stay duration is 3 days (2 nights). In addition, period 1 and 4 will be followed by 1 short visit and period 6 will be followed by 7 short visits (location Martini). There will be an option to do the last clinical day from period 1, 4 and 6 as an ambulatory visit. You can leave this period one day earlier and visit us the next day in a short visit. You will receive the study drug or placebo once every week for 6 consecutive weeks. The study drug and placebo will be given as an intravenous (iv) infusion.

Before the start of the study you will visit the medical screening centre in Groningen location Martini. 
Blood samples will be taken regularly during the study.

Risks and medical supervision

All potential drugs can cause adverse events; the extent to which this occurs differs. The study drug has been studied in animals. In animals no abnormalities were observed and the study medication was well tolerated.

The study drug has already been studied in healthy volunteers with dose levels up to 10 mg/kg intravenously. In this previous study that has also been conducted at PRA, the study drug was well tolerated at all dose levels without clear adverse events.

In another study that has recently be completed at PRA, the study drug was administered as an intravenous dose of 600 mg and compared to 75 mg and 600 mg of the study drug administered subcutaneously (sc). In this study, the study drug was generally well tolerated. However, based on preliminary data there was one adverse events (infusion reaction characterized by acute appearance of hives) that necessitated early discontinuation of the infusion. This adverse event was of mild intensity and resolved swiftly without medical intervention. In addition, a serious adverse event occurred after sc administration of 75 mg from the study drug. This volunteer suffered from acute and severe neck pain. Although the neck pain was transient, it was followed by persistent paralysis of the diaphragm which resulted in shortness of breath when lying flat. This adverse event was of moderate intensity at occurrence and the cause of this rare disorder was not known. As the first symptoms developed two weeks after administration of the drug, a link with the recent administration of the study drug could not be definitely ruled out. On the other hand, it could have been a coincidence as well. This serious adverse event is still ongoing but stable.

In another ongoing study, the study drug is being tested at a dose of 10 mg/kg in patients with atopic dermatitis (a type of eczema). In this study the study drug has been well tolerated so far. Development of a hypersensitivity or allergic reaction to the study drug as described above may occur and you may become more susceptible to infections.

You should be aware that the aforementioned adverse events and possibly other, still unknown adverse events, may occur during the study.

You will be under strict medical supervision during the study. Before the study and at the end of the study you will undergo an extensive medical screening.

Conditions for participation

You are a healthy male or female between 18 and 65 years old. You can only take part in the study if you do not smoke. Women are only allowed to participate in this study if they are willing to use sufficient contraception (e.g. hormonal contraceptives or intrauterine devices in combination with a condom) during the study, have been sterilized by hysterectomy or have been postmenopausal for at least two years.

The study will be executed under standardized conditions. Use of your own medication, alcohol, regular coffee and tea, cola, power drinks, chocolate (including products made of chocolate), grapefruit (juice) 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; this screening will take place within four weeks before the start of the study.

Download PDF
More info Less info

Group 3

€ 3.074,-

21 days stay

  • 28 Sep 2017 up to and including 1 Oct 2017
  • 5 Oct 2017 up to and including 7 Oct 2017
  • 12 Oct 2017 up to and including 14 Oct 2017
  • 19 Oct 2017 up to and including 22 Oct 2017
  • 26 Oct 2017 up to and including 28 Oct 2017
  • 2 Nov 2017 up to and including 5 Nov 2017

possible prolongation

  • Inapplicable
  • Inapplicable
  • Inapplicable
  • Inapplicable
  • Inapplicable
  • Inapplicable

checkups

  • 3 Oct 2017
  • 24 Oct 2017
  • 7 Nov 2017
  • 9 Nov 2017
  • 10 Nov 2017
  • 17 Nov 2017
  • 1 Dec 2017
  • 15 Dec 2017
  • 29 Dec 2017

Follow-up

Inapplicable
Group full

Group 4

€ 3.074,-

21 days stay

  • 23 Nov 2017 up to and including 26 Nov 2017
  • 30 Nov 2017 up to and including 2 Dec 2017
  • 7 Dec 2017 up to and including 9 Dec 2017
  • 14 Dec 2017 up to and including 17 Dec 2017
  • 21 Dec 2017 up to and including 23 Dec 2017
  • 28 Dec 2017 up to and including 31 Dec 2017

possible prolongation

  • Inapplicable
  • Inapplicable
  • Inapplicable
  • Inapplicable
  • Inapplicable
  • Inapplicable

checkups

  • 28 Nov 2017
  • 19 Dec 2017
  • 2 Jan 2018
  • 4 Jan 2018
  • 5 Jan 2018
  • 12 Jan 2018
  • 26 Jan 2018
  • 9 Feb 2018
  • 23 Feb 2018

Follow-up

Inapplicable
Group full

Call me back

We bellen terug tijdens kantooruren binnen 3 werkdagen.

Bel mij terug
  • ?

  • ?