{"type":"trials","record":{"id":42377,"source_id":"clinicaltrials-gov","external_id":"NCT04601909","title":"FX-322 in Adults With Age-Related Sensorineural Hearing Loss","brief_summary":"This is a Phase 1b, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter, safety study of FX-322, administered by intratympanic injection, in adults with age-related sensorineural hearing loss.","overall_status":"Completed","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Frequency Therapeutics","enrollment":30,"countries":["United States"],"start_date":"2020-09-17","completion_date":"2022-05-16","last_update_date":"2022-05-25","source_url":"https://clinicaltrials.gov/study/NCT04601909","editorial_summary":"A registered PHASE1 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:34.048307+00:00","last_seen_at":"2026-09-25T06:25:04.647+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"66 Years to 85 Years","comparator":"FX-322; Placebo","organization":"Frequency Therapeutics","interventions":["FX-322","placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Systemic Safety: Number of patients with treatment-related adverse events — 3 months","Local Safety: Number of patients with abnormal changes from baseline in otoscopic examinations — 3 months","Local Safety: The number of patients with abnormal changes from baseline in tympanometry — 3 months","Columbia-Suicide Severity Rating Scale (C-SSRS) — 3 months","Audiologic Response Endpoints: Speech Intelligibility - Word Recognition in Quiet (WR) — 3 months","Audiologic Response Endpoints: Speech Intelligibility - Words-In-Noise (WIN) — 3 months","Standard Pure Tone Audiometry — 3 months","Extended High Frequency Pure Tone Audiometry — 3 months","Tinnitus Assessment — 3 months"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Presbycusis","Hearing Loss, Sensorineural","Noise Induced Hearing Loss","Sudden Hearing Loss","FX-322","placebo"],"relevance_confidence":70,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Source terminology contains: presbycusis.","quality_checked_at":"2026-09-25T06:25:07.732232+00:00","duplicate_cluster_key":"id:nct04601909","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-09-17 to 2022-05-16","comparator":"FX-322; Placebo","confidence":"structured-source","population":"ALL · 66 Years to 85 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:25:04.666Z","intervention":["FX-322","placebo"],"participants":30,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Systemic Safety: Number of patients with treatment-related adverse events — 3 months","Local Safety: Number of patients with abnormal changes from baseline in otoscopic examinations — 3 months","Local Safety: The number of patients with abnormal changes from baseline in tympanometry — 3 months","Columbia-Suicide Severity Rating Scale (C-SSRS) — 3 months","Audiologic Response Endpoints: Speech Intelligibility - Word Recognition in Quiet (WR) — 3 months","Audiologic Response Endpoints: Speech Intelligibility - Words-In-Noise (WIN) — 3 months","Standard Pure Tone Audiometry — 3 months","Extended High Frequency Pure Tone Audiometry — 3 months","Tinnitus Assessment — 3 months"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"hearing-aging","is_published":true,"match_reasons":["Source terminology contains: presbycusis.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["controlled terminology","title context","study type"],"relevance_score":70,"intelligence_topics":{"name":"Hearing ageing","slug":"hearing-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/42377","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}