{"type":"trials","record":{"id":28348,"source_id":"clinicaltrials-gov","external_id":"NCT07637981","title":"First Clinical Study to Evaluate Safety, Tolerability & PK of DX243 in Healthy Volunteers and Patients With Hearing Loss","brief_summary":"Phase 2a: Multiple Ascending Dose (MAD) in male and female patients with hearing loss: The study will be conducted according to a randomised, placebo-controlled, double-blind design. A total of 24 patients, otherwise healthy, aged up to 75 years old, with mild to moderate hearing loss will be included. Two cohorts of 12 male or female patients (no ratio is required) will receive two different flat doses (low dose and high dose) ofDX243 or placebo for 29 days using SC administration. In each cohort of 12 patients, 4 will be randomised to placebo and 8 to DX243, so at the end of Phase 2a, 8 patients will have received placebo, 8 the low dose and 8 the high dose of DX243. The primary objective is to evaluate the safety and tolerability of DX243 administered subcutaneously after repeated doses. The secondary objectives are to detect preliminary signal of efficacy, using speech in noise tests, tonal and vocal audiometry, as well as tinnitus and quality of life.","overall_status":"Recruiting","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Dendrogenix","enrollment":24,"countries":["Belgium"],"start_date":"2026-05-13","completion_date":"2027-10-01","last_update_date":"2026-06-10","source_url":"https://clinicaltrials.gov/study/NCT07637981","editorial_summary":"A registered PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T00:17:13.50034+00:00","last_seen_at":"2026-09-25T06:25:04.647+00:00","metadata":{"sex":"ALL","acronym":"DX243-101","age_range":"18 Years to 75 Years","comparator":"Placebo","organization":"Dendrogenix","interventions":["DX243","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Safety and tolerability: incidence, nature, severity and causality of treatment emergent adverse events (TEAE) and (Ser…","Tolerability at the injection sites using a 1-5 scale Common Terminology Criteria for Adverse Events (CTCAE) for pain,…","Number of participants with at least one clinically significant abnormal laboratory result — For 7 months","Number of Participants With Abnormal ECG Findings — For 7 months","Change in Pure Tone Audiometry — For 7 months","Change in speech audiometry — For 7 months","Hearing Handicap Inventory for the Elderly- Screening (HHIE-S) questionnaire score — For 7 months","Severity of tinnitus — For 7 months","Distorsion Product OtoAcoustic Emission (DPOAE) — For 7 months","Quality of Life (QoL) assessed using 15iSSQ scale — For 7 months"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Age-related Hearing Loss","DX243","Placebo"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Source terminology contains: age-related hearing loss.","quality_checked_at":"2026-09-25T06:25:07.732232+00:00","duplicate_cluster_key":"id:nct07637981","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-05-13 to 2027-10-01","comparator":"Placebo","confidence":"structured-source","population":"ALL · 18 Years to 75 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":"2026-09-25T06:25:04.654Z","intervention":["DX243","Placebo"],"participants":24,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE2","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":["Safety and tolerability: incidence, nature, severity and causality of treatment emergent adverse events (TEAE) and (Ser…","Tolerability at the injection sites using a 1-5 scale Common Terminology Criteria for Adverse Events (CTCAE) for pain,…","Number of participants with at least one clinically significant abnormal laboratory result — For 7 months","Number of Participants With Abnormal ECG Findings — For 7 months","Change in Pure Tone Audiometry — For 7 months","Change in speech audiometry — For 7 months","Hearing Handicap Inventory for the Elderly- Screening (HHIE-S) questionnaire score — For 7 months","Severity of tinnitus — For 7 months","Distorsion Product OtoAcoustic Emission (DPOAE) — For 7 months","Quality of Life (QoL) assessed using 15iSSQ scale — For 7 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: age-related hearing loss.","Source terminology supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["controlled terminology","controlled context","study type"],"relevance_score":60,"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/28348","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}