A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Astellas Pharma Global Development, Inc.

Trial Summary

What is the purpose of this trial?This trial tested the safety and effectiveness of ASP0598 Otic Solution, a liquid medicine for the ear, in people with an affected ear. The medicine is applied directly into the ear to treat ear-related issues.

Eligibility Criteria

Treatment Details

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Single Ascending Dose (SAD): 0.03 mcgExperimental Treatment1 Intervention

Participants received single dose of 0.03 microgram (mcg) ASP0598 Otic Solution into the affected ear on day 1 and returned to the investigative site for assessments on days 2, 3, 8, 15, 29, and 57 \[End of Study (EOS)\].

Group II: SAD: 2.25 mcgExperimental Treatment1 Intervention

Participants received single dose of 2.25 mcg ASP0598 Otic Solution into the affected ear on day 1 and returned to the investigative site for assessments on days 2, 3, 8, 15, 29, and 57 (EOS).

Group III: SAD: 0.75 mcgExperimental Treatment1 Intervention

Participants received single dose of 0.75 mcg ASP0598 Otic Solution into the affected ear on day 1 and returned to the investigative site for assessments on days 2, 3, 8, 15, 29, and 57 (EOS).

Group IV: SAD: 0.15 mcgExperimental Treatment1 Intervention

Participants received single dose of 0.15 mcg ASP0598 Otic Solution into the affected ear on Day 1 and returned to the investigative site for assessments on days 2, 3, 8, 15, 29, and 57 (EOS).

Group V: Multiple Ascending Dose (MAD): 0.75 mcgExperimental Treatment1 Intervention

Participants received multiple doses of 0.75 mcg ASP0598 Otic Solution into the affected ear on days 1, 15 and 29 and returned to the investigative site for assessments on days 8, 15, 22, 29, 36, 57, and 85 (EOS).

Group VI: MAD: 2.25 mcgExperimental Treatment1 Intervention

Participants received multiple doses of 2.25 mcg ASP0598 Otic Solution into the affected ear on days 1, 15 and 29 and returned to the investigative site for assessments on days 8, 15, 22, 29, 36, 57, and 85 (EOS).

Group VII: SAD: PlaceboPlacebo Group1 Intervention

Participants received single dose of placebo matched to ASP0598 Otic Solution into the affected ear on day 1 and returned to the investigative site for assessments on days 2, 3, 8, 15, 29, and 57 (EOS).

Group VIII: MAD: PlaceboPlacebo Group1 Intervention

Participants received multiple doses of placebo matched to ASP0598 Otic Solution into the affected ear on days 1, 15 and 29 and returned to the investigative site for assessments on days 8, 15, 22, 29, 36, 57, and 85 (EOS).