{"type":"trials","record":{"id":42307,"source_id":"clinicaltrials-gov","external_id":"NCT04894071","title":"QA102 Phase 1 Study in Healthy Young and Older Adult Subjects","brief_summary":"This will be a double masked, randomized, placebo controlled, single and multiple oral dose study conducted in 3 parts. The safety and tolerability of single and multiple ascending oral doses of QA102 in healthy young and older adult subjects will be evaluated. The study will also characterize the pharmacokinetic (PK) profile of QA102 in plasma and urine after single and multiple oral doses of QA102. Besides, the metabolite profile of QA102 will also be characterized. Part 1 will comprise a single dose, sequential cohort design. Part 2 will comprise a multiple dose, sequential cohort study. Part 3 will comprise a multiple dose, single cohort study in older subjects.","overall_status":"Completed","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Smilebiotek Zhuhai Limited","enrollment":69,"countries":["United States"],"start_date":"2021-05-17","completion_date":"2021-11-15","last_update_date":"2022-01-14","source_url":"https://clinicaltrials.gov/study/NCT04894071","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":"2026-09-25T01:25:30.378222+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"18 Years to 75 Years","comparator":"Placebo group","organization":"Smilebiotek Zhuhai Limited","interventions":["QA102","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Incidence and severity of Adverse Events — Up to 7 days after dosing","Area under the plasma concentration-time curve (AUC) from time zero to 12 hours postdose [AUC0-12] — up to 12 hours pos…","Maximum observed plasma concentration [Cmax] — Up to 48 hours postdose","time of the maximum observed plasma concentration [tmax] — up to 48 hours postdose"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Age-related Macular Degeneration","QA102","Placebo"],"relevance_confidence":70,"source_quality_score":100,"freshness_score":50,"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:nct04894071","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2021-05-17 to 2021-11-15","comparator":"Placebo group","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":"2026-09-25T06:20:47.949Z","intervention":["QA102","Placebo"],"participants":69,"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":["Incidence and severity of Adverse Events — Up to 7 days after dosing","Area under the plasma concentration-time curve (AUC) from time zero to 12 hours postdose [AUC0-12] — up to 12 hours pos…","Maximum observed plasma concentration [Cmax] — Up to 48 hours postdose","time of the maximum observed plasma concentration [tmax] — up to 48 hours postdose"],"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.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["controlled terminology","title context","study type"],"relevance_score":70,"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/42307","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}