CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Focal Epilepsy.
Ability of the subjects or his/her authorized representative be fully informed of the nature and risks of the study and give informed consent in writing prior to entering the study.
Male and female aged 18 to 70 years, inclusive.
18.0 kg/m2 ≤BMI ≤ 34.0 kg/m2.
Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy [ILAE] Classification of Epilepsy (2017).
Subject has had documented previous EEGs indicating other patterns of epilepsy besides the focal epilepsy prior to dosing the study drug.
Subject has seizures secondary to drugs or alcohol use, ongoing infection, metabolic diseases or progressive central nervous system diseases or lesions at the investigator's assessments.
Subject has the history of pseudo seizures, conversion disorders, or other non-epileptic seizure conditions, or other non-epileptic ictal events that could be confused with seizures at the investigator's discretion and/or EEG evidence.
Subject has the presence or previous history of Lennox-Gastaut syndrome, some other related syndrome or evidence of both focal and generalized epilepsy at investigator's decisions.