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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose up to day 85

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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).

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