{"type":"trials","record":{"id":42133,"source_id":"clinicaltrials-gov","external_id":"NCT04594681","title":"A Safety Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration","brief_summary":"The purpose of this study is to evaluate safety and tolerability after administration of KHK4951 in healthy volunteers and patients with wet age-related macular degeneration.","overall_status":"Terminated","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Kyowa Kirin Co., Ltd.","enrollment":116,"countries":["Japan"],"start_date":"2020-09-16","completion_date":"2022-08-26","last_update_date":"2023-05-18","source_url":"https://clinicaltrials.gov/study/NCT04594681","editorial_summary":"A registered PHASE1 study indexed because it matched monitored longevity research terms. Registry status: Terminated. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:30.378222+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"20 Years","comparator":"Placebo","organization":"Kyowa Kirin Co., Ltd.","interventions":["Placebo","KHK4951"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Number of participants with adverse events — Day 1 to Day 43","Serum KHK4951 concentration — Healthy Volunteers: Day 1, Day2, Day4, Day8, Day12, Day16, Day21, Day23, Day 25, Day 29,…","Time to the maximum concentration — Day 1 to Day 43","The maximum concentration — Day 1 to Day 43","Area under the concentration-time curve — Day 1 to Day 43","Apparent clearance — Day 1 to Day 43","Elimination half-life — Day 1 to Day 43"],"design_description":"RANDOMIZED · SEQUENTIAL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Healthy Volunteers","Wet Age-related Macular Degeneration","Placebo","KHK4951"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct04594681","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-09-16 to 2022-08-26","comparator":"Placebo","confidence":"structured-source","population":"ALL · 20 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":"2026-09-25T06:20:47.925Z","intervention":["Placebo","KHK4951"],"participants":116,"study_design":"RANDOMIZED · SEQUENTIAL · 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":["Number of participants with adverse events — Day 1 to Day 43","Serum KHK4951 concentration — Healthy Volunteers: Day 1, Day2, Day4, Day8, Day12, Day16, Day21, Day23, Day 25, Day 29,…","Time to the maximum concentration — Day 1 to Day 43","The maximum concentration — Day 1 to Day 43","Area under the concentration-time curve — Day 1 to Day 43","Apparent clearance — Day 1 to Day 43","Elimination half-life — Day 1 to Day 43"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"vision-aging","is_published":true,"match_reasons":["Title contains controlled term: age-related macular degeneration.","Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Vision ageing","slug":"vision-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/42133","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}