{"type":"trials","record":{"id":41615,"source_id":"clinicaltrials-gov","external_id":"NCT07406438","title":"To Evaluate the Safety, Pharmacokinetics, and Efficacy of GB10 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)","brief_summary":"This study aims to preliminarily evaluate the efficacy and safety of GB10 intravitreal (IVT) injection for the treatment of patients with neovascular age-related macular degeneration (nAMD). It consists of two parts, single-ascending-dose escalation (SAD) and multiple-ascending-dose escalation (MAD). In SAD, a single IVT of up to 6 doses will be administered to up to 36 treatment-naïve or previously treated patients with nAMD. If the lowest dose is considered safe without dose-limiting toxicity, escalation will proceed to the next higher dose level. At the end of SAD, the two doses that best balance efficacy and safety will be selected and entered into MAD. In MAD, a single IVT of 2 doses will be administered to 12 treatment-naïve or previously treated patients with nAMD, who will be enrolled across the low- to high-dose levels. After GB10 intervention, the participants will undergo tests to evaluate the PK/PD characteristics of GB10 and ocular and non-ocular safety.","overall_status":"Not Yet Recruiting","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Shenzhen Kexing Pharmaceutical Co., Ltd.","enrollment":48,"countries":["China"],"start_date":"2026-02-12","completion_date":"2027-06-30","last_update_date":"2026-02-12","source_url":"https://clinicaltrials.gov/study/NCT07406438","editorial_summary":"A registered PHASE1 study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. 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":"50 Years to 80 Years","comparator":null,"organization":"Kexing Biopharm Co., Ltd.","interventions":["GB10"],"registry_source":"ClinicalTrials.gov","outcome_measures":["The incidence and severity of ocular adverse events — From enrollment to the end of treatment at 12 weeks","The incidence and severity of non-ocular adverse events — From enrollment to the end of treatment at 12 weeks","(SAD) The change in best corrected visual acuity (BCVA) from baseline after 4 weeks of treatment — From enrollment to t…","(MAD) The change in best corrected visual acuity (BCVA) from baseline after 12 weeks of treatment — From enrollment to…","(SAD) Change in central retinal subfield thickness (CST) from baseline at 4 weeks of treatment — From enrollment to the…","(MAD) Change in central retinal subfield thickness (CST) from baseline at 12 weeks of treatment — From enrollment to th…","Time of receiving rescue therapy for nAMD activity — From enrollment to the end of treatment at 12 weeks","Positive rate of anti-drug antibody and neutralizing antibody of GB10 — From enrollment to the end of treatment at 12 w…","Area under the drug-time curve from 0 to time t of GB10 — From enrollment to the end of treatment at 12 weeks","Area under the curve at the time of 0-infinity of GB10 — From enrollment to the end of treatment at 12 weeks","Peak concentration of GB10 — From enrollment to the end of treatment at 12 weeks","Peak time of GB10 — From enrollment to the end of treatment at 12 weeks","Clearance rate of GB10 — From enrollment to the end of treatment at 12 weeks","Half-life of GB10 — From enrollment to the end of treatment at 12 weeks","VEGF concentration — From enrollment to the end of treatment at 12 weeks","Ang2 concentration — From enrollment to the end of treatment at 12 weeks"],"design_description":"NON RANDOMIZED · SEQUENTIAL · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Neovascular Age-Related Macular Degeneration (nAMD)","GB10"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"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:nct07406438","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-02-12 to 2027-06-30","comparator":null,"confidence":"structured-source","population":"ALL · 50 Years to 80 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":"2026-09-25T06:20:47.842Z","intervention":["GB10"],"participants":48,"study_design":"NON RANDOMIZED · SEQUENTIAL · TREATMENT · NONE","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":["The incidence and severity of ocular adverse events — From enrollment to the end of treatment at 12 weeks","The incidence and severity of non-ocular adverse events — From enrollment to the end of treatment at 12 weeks","(SAD) The change in best corrected visual acuity (BCVA) from baseline after 4 weeks of treatment — From enrollment to t…","(MAD) The change in best corrected visual acuity (BCVA) from baseline after 12 weeks of treatment — From enrollment to…","(SAD) Change in central retinal subfield thickness (CST) from baseline at 4 weeks of treatment — From enrollment to the…","(MAD) Change in central retinal subfield thickness (CST) from baseline at 12 weeks of treatment — From enrollment to th…","Time of receiving rescue therapy for nAMD activity — From enrollment to the end of treatment at 12 weeks","Positive rate of anti-drug antibody and neutralizing antibody of GB10 — From enrollment to the end of treatment at 12 w…","Area under the drug-time curve from 0 to time t of GB10 — From enrollment to the end of treatment at 12 weeks","Area under the curve at the time of 0-infinity of GB10 — From enrollment to the end of treatment at 12 weeks","Peak concentration of GB10 — From enrollment to the end of treatment at 12 weeks","Peak time of GB10 — From enrollment to the end of treatment at 12 weeks","Clearance rate of GB10 — From enrollment to the end of treatment at 12 weeks","Half-life of GB10 — From enrollment to the end of treatment at 12 weeks","VEGF concentration — From enrollment to the end of treatment at 12 weeks","Ang2 concentration — From enrollment to the end of treatment at 12 weeks"],"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/41615","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}