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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.

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). 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.

The main objectives of this study are as follows; to determine the safety and tolerability of CpG ODN D35 when it is administered 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 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. All participants in a given group will receive the same volume of drug within the injection and the same number of injections. 

study timeline

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

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