A Phase IIa, Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Presence of SENS-401 in the Perilymph After 7 Days of Repeated Oral Administration in Adult Participants Scheduled for Cochlear Implantation

SENS-401-203

The aim of this study is to detect the presence of SENS-401 in the perilymph of participants undergoing cochlear implant surgery after 7 days of oral administration of SENS-401.

2022-08-10

2023-12-18

2024-06-01

Active (not recruiting)

Early phase I

27

Main Inclusion Criteria: Potential participants must fulfil all of the following main inclusion criteria to be eligible for the study: 1. Adults aged from 18 years and older; 2. Meets the locally approved indication for cochlear implantation. The individual must have freely consented to the cochlear implant surgery before being offered to participate in the SENS-401-203 study; 3. Signed and dated written informed consent; Main Exclusion Criteria: Individuals will be excluded from the study if any of the following main exclusion criteria apply: 1. Moderate to severe renal impairment defined by a creatinine clearance ≤ 60 ml/min 2. Any condition that, in the opinion of the Investigator, may compromise the safety or compliance of the participant or would preclude the participant from successful completion of the study 3. Unable or unwilling to comply with the protocol requirements 4. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 27, 'type': 'ESTIMATED'}}

2024-02-28