What does the study consist of?

The study is divided into three parts (Part 1: Single Ascending Dose; Part 2: Multiple Ascending Dose; and Part 3: Food Interaction). Sixty-eight healthy volunteers will be needed to conduct all three parts of the study. If you participate in one part of the study, you will not be able to participate in another part. Depending on the part of the study, it will last from 2 to 10 weeks.

If you are selected according to the criteria of the study protocol, you will be scheduled for one day at the IMIM Clinical Research Unit (CRU). A physical examination will be performed, details of your medical history will be collected, vital signs will be taken and blood tests will be performed. Once selected, you can be treated with the CTH120 molecule or with placebo (a product similar to the one we study, but without any active substance), randomly (as if a coin were tossed) you will be admitted to the CRU for at least two nights. You will also have to come in several times during the duration of the study for follow-up visits.

The study drug is new, CTH120. CTH120 is a novel small molecule that exhibits procognitive effects in animal models, completely restoring social abnormalities in FMR1 knockout (KO) mice, and thus has potential as a drug for the treatment of Fragile X syndrome and other neuroplasticity-intervened central nervous disorders (CNS).

In case you want to participate, we will do a telephone questionnaire to rule out, before coming to the center, if you have any disease or consume any substance/medication that may interfere with the results of the study and that are part of the exclusion criteria.

To perform the study you will need to spend a morning in the CRU to perform the initial assessment and check that you meet the criteria for participation. Depending on the part of the study, you will need to stay two nights in the CRU, in addition to several subsequent follow-up visits.

The study is authorized by the Agencia Española de los Medicamentos y Productos Sanitarios (AEMPS) and is performed following a protocol approved by the Comité de Ética de Investigación con Medicamentos del Parque de Salud Mar (CEIm-PSMAR).