RD 777/35000 – Simbec-Orion Skip to content

DISCOVER A NEW WAY TO HELP

If you are a healthy male aged between 18 and 50, then you may be eligible to participate in a clinical trial investigating a treatment being developed for a disease called Cutaneous Leishmaniasis (CL).

Maximum Inconvenience Payment of £1,750.

study information

Simbec-Orion Clinical Pharmacology will soon be running a study to investigate a new drug called CpG ODN D35. 

CpG ODN D35 is being developed for the treatment of a disease called Cutaneous Leishmaniasis (CL). This disease is caused by a parasite (an organism which lives on or in another organism and uses the host to survive) which infects the body of female sandflies. These types of fly bite humans, and this causes the parasite to be passed on and infect a human host. CL is the most common form of leishmaniasis with an estimated 600,000 to 1,000,000 new cases each year with the majority of cases being reported in South America, the Mediterranean, Middle East and Central Asia. This form of leishmaniasis is associated with ulceration and lifelong scarring of the skin and exposed parts of the body and is caused by over 15 different species of the Leishmania parasite.

Therefore, there is an unmet need to develop potential new treatments which could be more effective, and which could be associated with less side effects and which can be used in combination with current existing treatments.

The main objectives of this study are as follows:

  • To determine the safety and tolerability (the degree to which side effects of a drug can be tolerated) of CpG ODN D35 when it is administered as a subcutaneous injection (injection into the tissue layer between the skin and muscle) at different dose strengths on one occasion.
  • To investigate the concentration of CpG ODN D35 in the blood, how this concentration changes over a period of time and whether there are differences in the concentration profile between different dose strengths.

The purpose of the study is to evaluate the safety, tolerability and concentration of CpG ODN D35 in the blood when it is given as a single dose on one occasion at different dose strengths via an injection under the skin. In addition, the study will investigate the effect of CpG ODN D35 on the body (known as pharmacodynamics) and analyse the levels of certain biomarkers in the body. The study will consist of 4 planned groups of 8 participants: each group investigating a different dose strength starting at the lowest dose and gradually increasing in strength in each group. 

If you participate in this study, you will be required to stay at the Simbec-Orion clinical unit for a maximum period of 5 days (4 overnight stays) followed by a return visit on Day 7 and a post-study follow-up visit on Day 14 and you should therefore ensure that you are able to commit to completing this before agreeing to participate in the study. 

In this study, participants will either be given CpG ODN D35 or a placebo (which contains no active drug). Both CpG ODN D35 and the placebo will be administered in the form of one or more subcutaneous injections (injection into the fatty tissue layer between the skin and muscle). All participants in a given group will receive the same volume of drug within the injection and the same number of injections. The number of injections to be given will vary dependent on the dose strength which is being given in the group. 

Blood samples will be taken at set time points throughout the study in order to measure the concentration profile of CpG ODN D35 in the blood, how this changes over time and how this compares with the placebo and at each dose strength. 

study timeline

You will receive a maximum inconvenience payment of £1750 for participating in this clinical research.

APPLY NOW

Thank you for your interest in joining our panel of healthy volunteers, please register by completing the below form.

[[[["field16","less_than","18.0"],["field16","greater_than","30.1"],["field23","equal_to","Yes"],["field24","equal_to","Yes"],["field25","equal_to","No"],["field28","equal_to","Yes"],["field30","equal_to","Yes"],["field49","equal_to","Yes"],["field31","equal_to","Yes"],["field35","equal_to","Yes"],["field36","equal_to","Yes"],["field37","equal_to","Yes"],["field51","equal_to","Yes"],["field52","equal_to","Yes"],["field60","equal_to","Yes"],["field61","equal_to","Yes"],["field64","equal_to","Yes"],["field65","equal_to","Yes"],["field66","equal_to","Yes"],["field67","equal_to","No"]],[["show_fields","field44"]],"or"],[[["field16","greater_than","17.9"],["field16","less_than","30.2"]],[["show_fields","field23"]],"and"],[[["field23","equal_to","No"]],[["show_fields","field24"]],"and"],[[["field24","equal_to","No"]],[["show_fields","field25"]],"and"],[[["field25","equal_to","Yes"]],[["show_fields","field26,field59"]],"and"],[[["field26","equal_to","Yes"],["field26","equal_to","No"]],[["show_fields","field28"]],"or"],[[["field28","equal_to","No"]],[["show_fields","field29,field68"]],"and"],[[["field29","equal_to","Yes"],["field29","equal_to","No"]],[["show_fields","field30"]],"or"],[[["field30","equal_to","No"]],[["show_fields","field49"]],"and"],[[["field49","equal_to","No"]],[["show_fields","field31"]],"and"],[[["field35","equal_to","No"]],[["show_fields","field36"]],"and"],[[["field36","equal_to","No"]],[["show_fields","field37"]],"and"],[[["field37","equal_to","No"]],[["show_fields","field51"]],"and"],[[["field51","equal_to","No"]],[["show_fields","field52"]],"and"],[[["field52","equal_to","No"]],[["show_fields","field60"]],"and"],[[["field60","equal_to","No"]],[["show_fields","field61"]],"and"],[[["field62","equal_to","No"]],[["show_fields","field65"]],"and"],[[["field64","equal_to","No"]],[["show_fields","field65"]],"and"],[[["field65","equal_to","No"]],[["show_fields","field66"]],"and"],[[["field66","equal_to","No"]],[["show_fields","field67"]],"and"],[[["field67","equal_to","Yes"]],[["show_fields","field63,field57,field43"]],"and"],[[["field31","equal_to","No"]],[["show_fields","field35"]],"and"],[[["field61","equal_to","No"]],[["show_fields","field62"]],"and"],[[["field62","equal_to","Yes"]],[["show_fields","field64"]],"and"]]
1 Step 1

To enable us to make an assessment of your suitability for a Clinical Trial, we will first need to gather some personal details relating to your health. To ensure your suitability for a Clinical Trial, by ticking the checkbox you agree that the information you have provided is accurate to the best of your ability. Your personal data will be stored on our database which is only accessible by Simbec Research Ltd and our service providers. To aid in your suitability assessment, we will only share with companies that support us delivering our services. Under the current European Data Protection Laws (GDPR), you have a number of rights in relation to your personal data such as the right to access, right to rectification and right to be forgotten where appropriate. Please note: if you have not been contacted within 3 months of applying for a trial, please assume you are ineligible and that your data has been deleted from our system, if you believe you are eligible for another one of our trials, please apply again in 3 months.

For more information regarding our commitment to your privacy, please read our privacy policy.

Agreement

You must be between the age of 18-50 to participate in this trial. 

Your BMI must fall within the range of 18.0 – 30.1kg/m2 to participate in this trial. (Minimum of 60kg and maximum of 90kg)

Your BMI = [ Field17 / ( Field53 * Field53 ) ]

1. Do you regularly use illegal drugs?(i.e. Substances that are used for non-medicinal and leisure purposes. We test as part of the medical.)
2. Have you been diagnosed or tested positive for Coronavirus/COVID-19 within the last month?
3. Are you registered with a GP?(must be a UK resident for at least 1 year)
4. Are you taking any prescription or repeat medication from a GP or a chemist (including any over-the-counter medications, vitamins or supplements)?
5. Have you received a vaccine (including the COVID-19 vaccine) in the last 28 days?
6. Do you have an appointment for a COVID-19 vaccine in the coming 3 months?
7. Do you suffer from or ever had any serious illnesses as diagnosed by your GP or health professional?(e.g. neurological, endocrinal, cardiovascular, pulmonary, haematological, immunologic, psychiatric, gastrointestinal, renal, hepatic and metabolic disease)?
8. Do you suffer from/have a family history of any autoimmune diseases e.g., MS, type 1 diabetes or lupus?
9. Have you suffered from a serious infection in the last 2 weeks?
10. Have you taken part in a clinical trial of an un-marketed drug in the last 90 days or 3 months?
11. Have you taken part in a clinical trial of a marketed drug in the last 30 days?
12. Have you ever suffered from a serious allergic reaction or have a known severe allergy?
13. Do you have any history of allergic reaction to any drug or a history of hay fever?
14. Do you smoke or use any nicotine products (including vapes and eCigarettes)?
14a. Have you smoked or used any nicotine products within the last 6 months?
15. Have you donated more than 450 mL of blood in the last 3 months?
16. Do you drink alcohol?
16a. Do you consume more than 14 units per week?(For example, a can of beer/cider/lager is approximately 2 units)
17. Do you drink in excess of 6 cups of coffee or equivalent per day?
18. Have you had any body piercings or tattoos in the last 3 months?
19. Are you currently using some form of contraception (unless single with no current sexual partners)?

Thank you for your time and interest, but unfortunately based on your answer, you would be unable to participate in this trial at this time. But please feel free to fill out a general application form or keep a lookout for other clinical trials we may be recruiting for, as you may be eligible to help in a different trial

keyboard_arrow_leftPrevious
Nextkeyboard_arrow_right