Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-02 @ 5:20 AM
Study NCT ID:
NCT05158335
Status:
COMPLETED
Last Update Posted:
2023-08-09
First Post:
2021-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of MBX 2109 in Healthy Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double Blind'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-08', 'studyFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2021-12-02', 'lastUpdatePostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome Measures', 'timeFrame': 'Baseline through Day 40 (part A) or Day 60 (Part B)', 'description': 'Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs)'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome Measures 1', 'timeFrame': 'Baseline through Day 40 (part A) or Day 60 (Part B)', 'description': 'Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of MBX 2109'}, {'measure': 'Secondary Outcome Measures 2', 'timeFrame': 'Baseline through Day 40 (part A) or Day 60 (Part B)', 'description': 'Pharmacodynamics (PD): change from baseline in albumin corrected serum calcium'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of MBX 2109 in healthy volunteers.\n\nThis study includes 2 parts. Part A involves a single dose of MBX 2109 taken as a subcutaneous (SC) injection just under the skin. Part B involves repeat doses of MBX 2109 taken as a SC injection just under the skin. Each participant will enroll in only one part.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'Men and women of non-child bearing potential', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy men and women (of nonchildbearing potential) between 20 and 60 years of age, inclusive.\n2. Body mass index between 20.0 and 32.0 kg/m2, inclusive.\n3. No clinically meaningful findings on physical examination, electrocardiogram, laboratory tests or vital signs\n4. Subject has been given signed informed consent\n\nExclusion Criteria:\n\n1. History of any significant illness or disorder\n2. Acute illness within 30 days of administration of first dose of study drug\n3. Positive screening result for HIV, hepatitis B or hepatitis C\n4. History of or current substance abuse (drug or alcohol) within past 1 year or positive test for drugs of abuse during screening\n5. Use of nicotine-containing or vaping products within 3 months prior to screening or check-in\n6. Use of cannabis within 45 days prior to check-in\n7. Donation of blood within 3 months prior to screening, plasma within 2 weeks prior to screening or platelets within 6 weeks prior to screening\n8. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within past 30 days'}, 'identificationModule': {'nctId': 'NCT05158335', 'briefTitle': 'Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of MBX 2109 in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'MBX Biosciences'}, 'officialTitle': 'A Phase 1, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Single and Multiple Ascending Doses of MBX 2109 in Healthy Participants', 'orgStudyIdInfo': {'id': 'MBX-2H1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MBX 2109 (Part A)', 'description': 'Single ascending SC doses', 'interventionNames': ['Drug: MBX 2109 (Part A)']}, {'type': 'EXPERIMENTAL', 'label': 'MBX 2109 (Part B)', 'description': 'Repeated ascending SC doses', 'interventionNames': ['Drug: MBX 2109 (Part B)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MBX 2109 (Part A)', 'type': 'DRUG', 'description': 'Single ascending SC dose of MBX 2109: 50 µg, 150 µg, 300 µg, 460 µg, 600 µg', 'armGroupLabels': ['MBX 2109 (Part A)']}, {'name': 'MBX 2109 (Part B)', 'type': 'DRUG', 'description': 'Repeated ascending SC doses of MBX 2109: 200 µg, 300 µg, 460 µg, 600 µg, 900 µg', 'armGroupLabels': ['MBX 2109 (Part B)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single SC dose or repeated SC doses of placebo.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Labcorp Drug Development: Clinical Research Unit', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Labcorp Drug Development: Clinical Research Unit', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Mary Jane Geiger, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MBX Biosciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MBX Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}