protocolSection identificationModule nctId: NCT06367426, orgStudyIdInfo id: Pharmacobio, briefTitle: A Phase I Study of DDN-A-0101 in Healthy Volunteers and Elder People, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Pharmacobio, class: INDUSTRY, descriptionModule briefSummary: The study is a Phase I, randomized double-blind, placebo-controlled, single and multiple dosing, dose-escalation study of the oral administration of DDN-A-0101 in healthy adults and elderly subjects, conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: To maintain double-blindness, DDN-A-0101 tablets and placebo with the same formulation and properties that cannot be distinguished in appearance will be used, and sub-packaging will also be the same., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: DDN-A-0101 (SAD), interventions name: DDN-A-0101 (MAD), interventions name: Placebo (SAD), interventions name: Placebo (MAD), outcomesModule primaryOutcomes measure: Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs, primaryOutcomes measure: Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs, primaryOutcomes measure: Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs, primaryOutcomes measure: Assessment of safety and tolerability of DDN-A-0101 by monitoring ECG, primaryOutcomes measure: Assessment of safety and tolerability of DDN-A-0101 by C-SSRS measurement, primaryOutcomes measure: Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests, primaryOutcomes measure: Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests, primaryOutcomes measure: Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin, an indicator of of DDN-A-0101 in plasma, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in plasma, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in plasma, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in plasma, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in plasma, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in plasma, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in plasma, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in plasma, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in urine, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in urine, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in urine, secondaryOutcomes measure: Assessment of pharmacodynamics of DDN-A-0101 for PART2 MAD test, secondaryOutcomes measure: Assessment of pharmacodynamics of DDN-A-0101 for PART2 MAD test, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University College of Medicine and Hospital, status: RECRUITING, city: Seoul, zip: 03080, country: Korea, Republic of, contacts name: In-Jin Jang, Doctor, role: CONTACT, phone: 82-2-740-8290, email: ijjang@snu.ac.kr, geoPoint lat: 37.566, lon: 126.9784, hasResults: False