Die Studie

During this trial, the effect of a one-weekly dosing will be compared to a dosing two times per week of the new compound. This will be done at different dosing levels. The new compound is in development for the prevention of dengue infections and for the treatment of dengue infections. Dengue occurs in tropical and subtropical areas and is transmitted by mosquitoes. Symptoms of dengue fever are mainly fever and severe headache.

A blood sampling device will be tested in one group during the trial. This will be determined by chance and you will notified if you are in this group before the start of the trial. The device will be tested at home on two separate moments, which will be done by yourself. You will also be asked to fill out a questionnaire.

Who can participate?

  • You are a healthy male or female
  • You are between 18 and 55 years old
  • You do not smoke and you do not use nicotine-containing products.
  • Your body weight is at least 50 kg and your Body Mass Index (BMI) is between 18 and 30 kg/m2.
  • You do not smoke and you do not use nicotine-containing products.

  • As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
    • You have passed the menopause (no periods for at least 12 months);
    • You are using adequate contraception (for example the contraceptive pill or intra-uterine device) in combination with a condom;
    • You have been sterilized or your male partner has been sterilized;
    • You are solely sexually active with women;
    • You abstain from heterosexual intercourse (you are not sexually active) according to your lifestyle.
       
  • As a male you can only participate if you meet one of the following conditions.
    • You are using a condom in combination with an additional contraception method used by your female partner;
    • You have been sterilized and you are using a condom;
    • Your female partner is sterilized or postmenopausal and you are using a condom;
    • You are solely sexually active with men and you are using a condom;
    • You abstain from heterosexual intercourse (you are not sexually active) according to your lifestyle.
       
  • You cannot participate in the trial if you have participated in another clinical trial in the 1 month prior to the first administration in this clinical trial (counting from the last dosing). For studies in which you received a biological drug, this is 3 months.

  • You are allowed to receive the COVID-19 vaccine during this trial.

  • To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.

Zeitraum

Group B1b  

2× 3 days and 2× 7 days stay

 
  • 20 May 2022 up to and including 26 May 2022
  • 29 May 2022 up to and including 31 May 2022
  • 5 Jun 2022 up to and including 7 Jun 2022
  • 12 Jun 2022 up to and including 18 Jun 2022
 

short visit

 
  • 20 Jun 2022
  • 27 Jun 2022
  • 4 Jul 2022
  • 10 Jul 2022
 

follow-up

 
  • 18 Jul 2022
 

 

Group A2a / B2a  

2× 6 days, 7 days en 8 days stay

 
  • 19 Jun 2022 up to and including 26 Jun 2022
  • 28 Jun 2022 up to and including 3 Jul 2022
  • 5 Jul 2022 up to and including 10 Jul 2022
  • 12 Jul 2022 up to and including 18 Jul 2022
 

short visit

 
  • 19 Jul 2022
  • 20 Jul 2022
  • 23 Jul 2022
  • 30 Jul 2022
  • 6 Aug 2022
  • 12 Aug 2022
 

follow-up

 
  • 20 Aug 2022
 

Aufwandsentschädigung

  • You will receive a gross compensation of € 3866 for participation in group 1.
  • You will receive a gross compensation of € 3834 for participation in group 3.
  • For participation in group 2 and 4 of the trial, you will receive a gross compensation of € 4554.

Travel 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 round trip, regardless of the mode of transportation.