Stopped: Lack of Efficacy
The primary purpose of this study was to evaluate the safety and tolerability of ASP0598 Otic Solution. This study also evaluated the efficacy of ASP0598 otic solution.
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) in SAD
Timeframe: From first dose up to day 57
Number of Participants With AE of Special Interest as Cholesteatoma or Ear Neoplasm in SAD
Timeframe: From first dose up to day 57
Number of Participants With AE of Special Interest as Ototoxic Symptoms (Tinnitus, Sensorineural Hearing Loss, Dizziness) in SAD
Timeframe: From first dose up to day 57
Number of Participants With AE of Special Interest as Otitis Media or Otitis Externa in SAD
Timeframe: From first dose up to day 57
Change From Baseline in Bone Conduction Hearing at 1, 2, 4 kHz by Pure Tone Audiometry at Week 8/EOS in SAD
Timeframe: Baseline and week 8
Change From Baseline in TVAS at Week 8/EOS in SAD
Timeframe: Baseline and week 8
Number of Participants With TEAEs in MAD
Timeframe: From first dose up to day 85
Number of Participants With AE Special Interest as Cholesteatoma or Ear Neoplasm in MAD
Timeframe: From first dose up to day 85
Number of Participants With AE of Special Interest as Ototoxic Symptoms (Tinnitus, Sensorineural Hearing Loss, Dizziness) in MAD
Timeframe: From first dose up to day 85
Number of Participants With AE of Special Interest as Otitis Media or Otitis Externa in MAD
Timeframe: From first dose up to day 85
Change From Baseline in Bone Conduction Hearing at 1, 2, 4 kHz by Pure Tone Audiometry at Week 12/EOS in MAD
Timeframe: Baseline and week 12
Change From Baseline in TVAS at Week 12/EOS in MAD
Timeframe: Baseline and week 12