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.
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.
You will receive a maximum inconvenience payment of £1750 for participating in this clinical research.
Thank you for your interest in joining our panel of healthy volunteers, please register by completing the below form.