protocolSection identificationModule nctId: NCT06309667, orgStudyIdInfo id: SL-MG12-P1, briefTitle: A Study to Assess Safety, Pharmacokinetics and Pharmacodynamics of PG-102(MG12) in Healthy Volunteers, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-17, primaryCompletionDateStruct date: 2024-06-26, completionDateStruct date: 2024-06-26, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: ProGen. Co., Ltd., class: OTHER, descriptionModule briefSummary: This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B) ascending dose, phase 1 study to investigate the safety, tolerability and pharmacokinetic and pharmacodynamics following subcutaneous injections of PG-102(MG12) in healthy adult participants.This study will be conducted in 2 Parts (Part A and B), with up to 5 cohorts in each part (Part A; Cohorts A1 to A5 and Part B; Cohorts B1 to B5)., conditionsModule conditions: Healthy, conditions: Overweight, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: PG-102(MG12), interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of participants with treatment-emergent adverse events (TEAEs) for Part A, primaryOutcomes measure: Number of participants with treatment-emergent adverse events (TEAEs) for Part B, primaryOutcomes measure: Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part A, primaryOutcomes measure: Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part B, primaryOutcomes measure: Number of participants with clinically significant abnormalities in vital signs for Part A, primaryOutcomes measure: Number of participants with clinically significant abnormalities in vital signs for Part B, primaryOutcomes measure: Number of participants with clinically significant abnormalities in 12-lead ECGs for Part A, primaryOutcomes measure: Number of participants with clinically significant abnormalities in 12-lead ECGs for Part B, secondaryOutcomes measure: Maximum plasma concentration (Cmax) for Part A, secondaryOutcomes measure: Maximum plasma concentration (Cmax) for Part B, secondaryOutcomes measure: Time to maximum plasma concentration (tmax) for Part A, secondaryOutcomes measure: Time to maximum plasma concentration (tmax) for Part B, secondaryOutcomes measure: Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part A, secondaryOutcomes measure: Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part B, secondaryOutcomes measure: Terminal half-life (t1/2) for Part A, secondaryOutcomes measure: Terminal half-life (t1/2) for Part B, secondaryOutcomes measure: Apparent total clearance (CL/F) for Part A, secondaryOutcomes measure: Apparent total clearance (CL/F) for Part B, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Catholic University Seoul St.Mary Hospital,, status: RECRUITING, city: Seocho, state: Seoul, zip: 06591, country: Korea, Republic of, contacts name: Kyunghwa Son, Ph.D, role: CONTACT, phone: 02-6098-2818, email: bd@progen.co.kr, geoPoint lat: 37.49056, lon: 127.02, hasResults: False