Informationen zur Studie :
Für eine Medikamentenstudie werden gesunde Frauen und Männer im Alter von 18–45 Jahren gesucht. AIC263029 ist ein Arzneimittel in klinischer Erprobung und wird zur Behandlung von BK-Virus Infektionen entwickelt. Das BK-Virus wird auch als Humanes Polyomavirus bezeichnet. Hierbei handelt es sich um eine Erstanwendungsstudie mit 5 stationären Aufenthalten und 6 ambulanten Visiten. Start Februar 2025.
Studienumfang:
Ein-/Ausschlusskriterien:
Aufwandsentschädigung:
Sie erhalten für die Teilnahme an dieser Studie eine Aufwandsentschädigung von
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We, CRS, are an internationally successful group of companies with almost 300 employees. We carry out clinical studies on behalf of numerous manufacturers of medicines and medical products. The tolerability and effectiveness of newly developed products are examined on healthy test subjects and patients who volunteer to do so. This joint commitment helps to improve the quality of life of many people.
As a test subject or patient, you benefit from our 40 years of experience in the field of clinical research in most medical disciplines. You can find us at three locations throughout Germany: Kiel, Berlin and Mannheim.
Your right to information
You naturally have the right to find out from us at any time what personal data we have about you and what we use it for. In such cases and if you have any questions or comments about data protection at CRS, please write to:
CRS Clinical Research Services Management GmbH
Data Protection Officer
Friedrich-König-Str. 3-5
D-68167 Mannheim
Or send an email to:Datenschutzbeauftragter(at)crs-group.de
First of all, participation in a clinical study is a voluntary decision that you can withdraw at any time and without giving reasons – before or during the study.
After initial contact by phone or email, you will be invited to an information event about „your“ clinical study. This group meeting lasts 60 to 90 minutes and a doctor will explain the details. The doctor will explain the test substance and possible side effects. You will also have the opportunity to have a one-on-one conversation with the study doctor. You will also receive detailed written information that you can read at your leisure at home. Only then will you decide and, if necessary, give your written consent.
Afterwards, like all other participants, you will undergo a thorough preliminary examination (screening), the treatment phase and the follow-up examination.
On the screening day, you will travel to one of our CRS study centers. You will be carefully examined by the CRS team – this includes blood and urine tests, for example. Based on the results, the doctor will assess whether you are suitable for the study. You will receive precise instructions on what you need to observe before and during the study – for example with regard to diet and stimulants.
During the treatment phase, you take the medication or medications that the respective clinical study is testing for tolerability or effectiveness. The frequency and duration of administration vary greatly, ranging from a single dose to multiple doses over a longer period of time. The amount of time required and the amount of time you need to be present at the respective CRS study center therefore vary. This can be a few days or a few weeks. During this time, you will be examined regularly and take part in special tests. Physical activity and nutrition depend on the requirements of the respective study. The amount of compensation is based on these criteria.
For the success of the study, it is essential that you arrive on time for all agreed appointments. You must also tell the study doctor truthfully about any previous illnesses and any changes in your health – as well as any additional medication you take during the study. This is for your safety. Every study ends with a comprehensive follow-up examination. This way we can be sure that you have left the CRS study center unharmed. We meticulously check whether side effects occur. If in doubt, you will receive appropriate treatment.
Requirements for Study Participation
If you decide to take part in a clinical trial, you become an important member of the CRS research community. To do so, you must be of legal age and have full legal capacity. The type of study determines which other criteria play a role in selecting participants – for example, age and gender, childbearing potential and contraception, smoker/non-smoker, weight (body mass index BMI) and possibly other selection factors. Some studies are looking for people with pre-existing conditions – these can be, for example, diabetes mellitus, cardiovascular disease or chronic respiratory diseases such as asthma and COPD.
You can find more detailed information about the requirements in our study offers. Our study doctors determine individual suitability in a detailed preliminary examination. If it proves necessary for medical or other reasons, the responsible doctors can exclude study participants from the study at any time.
There are very strict and binding legal regulations for clinical trials as well as high ethical standards that we are obliged to adhere to.
The following inclusion criteria generally apply to Healthy subjects :
The following inclusion criteria also apply to Diabetics :
CRS Clinical Research Services Berlin Siemensdamm 65 13627 Berlin