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ASP0598 for Perforated Eardrum

Phase 1 & 2
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose up to day 85
Awards & highlights

Summary

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.

Eligible Conditions
  • Chronic Perforated Eardrum

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose up to day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose up to day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Bone Conduction Hearing at 1, 2, 4 kHz by Pure Tone Audiometry at Week 12/EOS in MAD
Change From Baseline in Bone Conduction Hearing at 1, 2, 4 kHz by Pure Tone Audiometry at Week 8/EOS in SAD
Change From Baseline in TVAS at Week 12/EOS in MAD
+9 more
Secondary outcome measures
Change From Baseline in TMP Size at Week 12 for Dose Expansion
Change From Baseline in TMP Size at Week 12 for MAD
Change From Baseline in TMP Size at Week 16 for Dose Expansion
+9 more

Trial Design

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).

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
197 Previous Clinical Trials
122,100 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,801 Previous Clinical Trials
8,070,294 Total Patients Enrolled
~7 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
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