A Study to Evaluate the Safety, Tolerability, and Efficacy of CB03-154 in Adult Patients With Focal Epilepsy

CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Focal Epilepsy.

Inclusion Criteria: 1. 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. 2. Male and female aged 18 to 70 years, inclusive. 3. 18.0 kg/m2 ≤BMI ≤ 34.0 kg/m2. 4. Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy \[ILAE\] Classification of Epilepsy (2017). 5. Prior neuroimaging within the last 5 years and documentation are available to rule out progressive structural central nervous system abnormalities at the time of the diagnosis of epilepsy. 6. Treatment with a stable dose of 1 to 3 allowable current AEDs for at least one month prior to screening, during baseline, and throughout the duration of the DBP. 7. Prior to screening and during baseline period, subjects must have at least 6 focal seizures without status epilepticus, with or without focal to bilateral tonic-clonic. 8. If a female, must be: * Postmenopausal, defined as amenorrhea for at least 12 months, and confirmed by blood follicle stimulating hormone (FSH) at Screening, OR * Surgically sterile with a documented hysterectomy, partial hysterectomy, bilateral oophorectomy, or bilateral tubal ligation at least 6 months prior to Screening, OR * If of child-bearing potential, heterosexually active females with male partners must be using an acceptable and highly effective method of contraception at least one menstrual cycle before first study drug administration and continuing until at least 3 months after the last dose of the study drug. If a female subject is abstinent, she must agree to use an acceptable and highly effective form of birth control as above once she becomes heterosexually active during the study. 9. If a female of child-bearing potential, must have a negative pregnancy test result at Screening and Check-in. 10. If a male, if heterosexually sexually active with a female partner of child-bearing potential and has not had a vasectomy, must agree to use a highly effective method of contraception and deemed appropriate by the Investigator and must not donate sperm during the study and for 3 months after the last dose of study drug. 11. Able to keep accurate seizure diaries. Exclusion Criteria: 1. Subject has had documented previous EEGs indicating other patterns of epilepsy besides the focal epilepsy prior to dosing the study drug. 2. 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. 3. 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. 4. 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. 5. Subject has the history of status epilepticus within 6 months prior to screening. 6. Subject has only uncountably repetitive seizures occurring within 6 months prior to screening. 7. Subject has the history of neurosurgery for seizures \