{"type":"trials","record":{"id":41858,"source_id":"clinicaltrials-gov","external_id":"NCT06832657","title":"Study of JMKX003948 Ophthalmic Suspension in Healthy Participants","brief_summary":"The study is a randomized, double-blind, placebo-controlled, phase 1 study of JMKX003948 Ophthalmic Suspension to evaluate the safety, tolerability and PK of single and multiple ascending doses in healthy participants. Participant will be randomized to receive either JMKX003948 Ophthalmic Suspension (1%, 2%, 3% or 5%) or matching placebo (JMKX003948 Ophthalmic Suspension: placebo= 6: 2, N=8 per cohort). Five cohorts (Cohort 1-5) are planned. Cohorts could also de-escalate to a lower concentration if current formulation was not tolerated (Cohort 1b, 2b and 3b). In case of de-escalation, Cohort 1b and 2b will continue to escalate to Cohort 1c and Cohort 2c, respectively. Participants will be admitted to the site on Day -1 after screening (up to 28 days), and remain domiciled until Day 14 for Cohort 1-4, Day 8 for other cohorts.","overall_status":"Not Yet Recruiting","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Jemincare","enrollment":40,"countries":[],"start_date":"2025-02-01","completion_date":"2025-12-01","last_update_date":"2025-02-18","source_url":"https://clinicaltrials.gov/study/NCT06832657","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":"18 Years to 45 Years","comparator":"Placebo","organization":"Jemincare","interventions":["JMKX003948 Ophthalmic Suspension","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Adverse events (AEs) — From Day1 to up to Day14","Number of Participants With abnormal Ophthalmic examination — From Day1 to up to Day14","Maximum concentration (Cmax) — From Day1 to up to Day14","Area under the concentration-time curve — From Day1 to up to Day14","Time to Cmax (Tmax) — From Day1 to up to Day14","Elimination half-life (t1/2) — From Day1 to up to Day14"],"design_description":"RANDOMIZED · SEQUENTIAL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Age-Related Macular Degeneration (AMD)","Diabetic Macular Edema (DME)","JMKX003948 Ophthalmic Suspension","Placebo"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Source terminology contains: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct06832657","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-02-01 to 2025-12-01","comparator":"Placebo","confidence":"structured-source","population":"ALL · 18 Years to 45 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":"2026-09-25T06:20:47.881Z","intervention":["JMKX003948 Ophthalmic Suspension","Placebo"],"participants":40,"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":["Adverse events (AEs) — From Day1 to up to Day14","Number of Participants With abnormal Ophthalmic examination — From Day1 to up to Day14","Maximum concentration (Cmax) — From Day1 to up to Day14","Area under the concentration-time curve — From Day1 to up to Day14","Time to Cmax (Tmax) — From Day1 to up to Day14","Elimination half-life (t1/2) — From Day1 to up to Day14"],"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":["Source terminology contains: age-related macular degeneration.","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":"Vision ageing","slug":"vision-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/41858","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}