Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT06309667
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2024-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of PG-102 (MG12) in Healthy Adult and Obesity Participants.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2024-03-07', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-emergent adverse events (TEAEs) for Part A', 'timeFrame': 'Baseline to Day 29', 'description': 'Number of participants with treatment-emergent adverse events (TEAEs)'}, {'measure': 'Number of participants with treatment-emergent adverse events (TEAEs) for Part B', 'timeFrame': 'Baseline to Day 57', 'description': 'Number of participants with treatment-emergent adverse events (TEAEs)'}, {'measure': 'Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part A', 'timeFrame': 'Baseline to Day 29', 'description': 'Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0'}, {'measure': 'Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part B', 'timeFrame': 'Baseline to Day 57', 'description': 'Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0'}, {'measure': 'Number of participants with clinically significant abnormalities in vital signs for Part A', 'timeFrame': 'Baseline to Day 29', 'description': 'Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)'}, {'measure': 'Number of participants with clinically significant abnormalities in vital signs for Part B', 'timeFrame': 'Baseline to Day 57', 'description': 'Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)'}, {'measure': 'Number of participants with clinically significant abnormalities in 12-lead ECGs for Part A', 'timeFrame': 'Baseline to Day 29', 'description': 'Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)'}, {'measure': 'Number of participants with clinically significant abnormalities in 12-lead ECGs for Part B', 'timeFrame': 'Baseline to Day 57', 'description': 'Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)'}], 'secondaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax) for Part A', 'timeFrame': 'Baseline to Day 29', 'description': 'Maximum plasma concentration (Cmax)'}, {'measure': 'Maximum plasma concentration (Cmax) for Part B', 'timeFrame': 'Baseline to Day 57', 'description': 'Maximum plasma concentration (Cmax)'}, {'measure': 'Time to maximum plasma concentration (tmax) for Part A', 'timeFrame': 'Baseline to Day 29', 'description': 'Time to maximum plasma concentration (tmax)'}, {'measure': 'Time to maximum plasma concentration (tmax) for Part B', 'timeFrame': 'Baseline to Day 57', 'description': 'Time to maximum plasma concentration (tmax)'}, {'measure': 'Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part A', 'timeFrame': 'Baseline to Day 29', 'description': 'Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t)'}, {'measure': 'Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part B', 'timeFrame': 'Baseline to Day 57', 'description': 'Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t)'}, {'measure': 'Terminal half-life (t1/2) for Part A', 'timeFrame': 'Baseline to Day 29', 'description': 'Terminal half-life (t1/2)'}, {'measure': 'Terminal half-life (t1/2) for Part B', 'timeFrame': 'Baseline to Day 57', 'description': 'Terminal half-life (t1/2)'}, {'measure': 'Apparent total clearance (CL/F) for Part A', 'timeFrame': 'Baseline to Day 29', 'description': 'Apparent total clearance (CL/F)'}, {'measure': 'Apparent total clearance (CL/F) for Part B', 'timeFrame': 'Baseline to Day 57', 'description': 'Apparent total clearance (CL/F)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Overweight']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B, C) 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.\n\nThis study will be conducted in 3 Parts (Part A, B and C), with up to 5 cohorts in each part.', 'detailedDescription': 'Part A (SAD):\n\nIn Part A, subjects will receive a single dose of study drug, and the safety and efficacy of PG-102(MG12) will be evaluated in healthy subjects.\n\nPart B (MAD):\n\nIn Part B, subjects will receive once-weekly doses of the study drug for 4 weeks, and the safety and efficacy of PG-102(MG12) will be evaluated in otherwise healthy overweight adult subjects.\n\nPart C (MAD):\n\nIn Part C, obese participants will receive five repeated subcutaneous doses of the study drug, and the safety and tolerability of PG-102 (MG12) will be assessed across two cohorts based on prior safety data from Part B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female participants, aged 18 to 65 years inclusive at the time of signing informed consent\n2. Body mass index (BMI) of 18 to 30kg/m2 (inclusive) for Part A, Body mass index (BMI) of 25 to 30kg/m2 (inclusive) for Part B and Body mass index (BMI) 30 kg/m² or higher for Part C\n\n\\[Exclusion Criteria\\]\n\n1. History of administration of prescription drugs, herbal medicines, over-the-counter drugs, or vitamin supplements within 10 days prior to the study or history of the following drugs and/or other foods within 90 days prior to screening:\n\n * Drugs that affect body weight (such as obesity medications, psychiatric drugs, beta blockers, diuretics, contraceptives, female hormones, proton-pump inhibitors (PPIs), H2 receptor antagonists, health functional foods/supplements, and formulas designed for weight control).\n * Drugs that have the potential to impact blood sugar, liver fat, and intestinal microorganisms (including GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, thiazolidinediones (TZDs), fish oil, polyunsaturated fatty acids (PUFA), and ursodeoxycholic acid (UDCA)), as well as individuals who are currently using insulin.\n2. History of gastrointestinal diseases (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs.\n3. History of acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy.\n4. History of surgical treatment for obesity within 2 years (example: bariatric surgery, gastric banding etc) or gastrointestinal procedures for weight loss (including LAP-BAND®), or uncontrolled gastrointestinal disorders at Screening (e.g., peptic ulcer, gastroesophageal reflux disease)."}, 'identificationModule': {'nctId': 'NCT06309667', 'briefTitle': 'A Study to Investigate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of PG-102 (MG12) in Healthy Adult and Obesity Participants.', 'organization': {'class': 'OTHER', 'fullName': 'ProGen. Co., Ltd.'}, 'officialTitle': 'A Double-blind, Randomized, Placebo Controlled, Combined Single (Part A) and Multiple (Part B, C) Ascending Dose, Phase 1 Study to Investigate the Safety, Tolerability and Pharmacokinetic and Pharmacodynamics Following Subcutaneous Injections of PG-102(MG12) in Healthy Adult and Obesity Participants', 'orgStudyIdInfo': {'id': 'SL-MG12-P1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A1 - Single Ascending Dose', 'description': 'PG-102(MG12) Dose 1 (N=8) Subcutaneous injection', 'interventionNames': ['Drug: PG-102(MG12)', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A2 - Single Ascending Dose', 'description': 'PG-102(MG12) Dose 2 (N=8) Subcutaneous injection', 'interventionNames': ['Drug: PG-102(MG12)', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A3 - Single Ascending Dose', 'description': 'PG-102(MG12) Dose 3 (N=8) Subcutaneous injection', 'interventionNames': ['Drug: PG-102(MG12)', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A4 - Single Ascending Dose', 'description': 'PG-102(MG12) Dose 4 (N=8) Subcutaneous injection', 'interventionNames': ['Drug: PG-102(MG12)', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A5 - Multiple Ascending Dose', 'description': 'PG-102(MG12) Dose 5 (N=8) Subcutaneous injection', 'interventionNames': ['Drug: PG-102(MG12)', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B1 - Multiple Ascending Dose', 'description': 'PG-102(MG12) Dose 1 (N=6) Subcutaneous injection', 'interventionNames': ['Drug: PG-102(MG12)', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B2 - Multiple Ascending Dose', 'description': 'PG-102(MG12) Dose 1\\~5 (N=6) Subcutaneous injection', 'interventionNames': ['Drug: PG-102(MG12)', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B3 - Multiple Ascending Dose', 'description': 'PG-102(MG12) Dose 1\\~5 (N=6) Subcutaneous injection', 'interventionNames': ['Drug: PG-102(MG12)', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort S - Multiple Ascending Dose', 'description': 'PG-102(MG12) Optimal Dose (N=6) Subcutaneous injection', 'interventionNames': ['Drug: PG-102(MG12)', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C1 - Multiple Ascending Dose', 'description': 'PG-102(MG12) Dose 1 (N=12) Subcutaneous injection', 'interventionNames': ['Drug: PG-102(MG12)', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C2 - Multiple Ascending Dose', 'description': 'PG-102(MG12) Dose 1 (N=12) Subcutaneous injection', 'interventionNames': ['Drug: PG-102(MG12)', 'Other: Placebo']}], 'interventions': [{'name': 'PG-102(MG12)', 'type': 'DRUG', 'description': 'GLP-1 and GLP-2 fusion protein', 'armGroupLabels': ['Cohort A1 - Single Ascending Dose', 'Cohort A2 - Single Ascending Dose', 'Cohort A3 - Single Ascending Dose', 'Cohort A4 - Single Ascending Dose', 'Cohort A5 - Multiple Ascending Dose', 'Cohort B1 - Multiple Ascending Dose', 'Cohort B2 - Multiple Ascending Dose', 'Cohort B3 - Multiple Ascending Dose', 'Cohort C1 - Multiple Ascending Dose', 'Cohort C2 - Multiple Ascending Dose', 'Cohort S - Multiple Ascending Dose']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo drug of PG-102(MG12)', 'armGroupLabels': ['Cohort A1 - Single Ascending Dose', 'Cohort A2 - Single Ascending Dose', 'Cohort A3 - Single Ascending Dose', 'Cohort A4 - Single Ascending Dose', 'Cohort A5 - Multiple Ascending Dose', 'Cohort B1 - Multiple Ascending Dose', 'Cohort B2 - Multiple Ascending Dose', 'Cohort B3 - Multiple Ascending Dose', 'Cohort C1 - Multiple Ascending Dose', 'Cohort C2 - Multiple Ascending Dose', 'Cohort S - Multiple Ascending Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06591', 'city': 'Seocho', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Catholic University Seoul St.Mary Hospital,', 'geoPoint': {'lat': 37.49056, 'lon': 127.02}}], 'overallOfficials': [{'name': 'Seunghoon Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catholic University Seoul St.Mary Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProGen. Co., Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}