Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
Study NCT ID:
NCT06778850
Status:
RECRUITING
Last Update Posted:
2025-03-07
First Post:
2025-01-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I/IIa Clinical Study to Assess the Single and Multiple Ascending Doses of MDR-001 Tablets in Healthy Participants and Obese/ Overweight 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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 131}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2025-01-07', 'studyFirstSubmitQcDate': '2025-01-12', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration', 'timeFrame': 'Baseline through Day 84', 'description': 'A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module'}], 'secondaryOutcomes': [{'measure': 'PK: Area Under the Concentration Versus Time Curve (AUC) of MDR-001', 'timeFrame': 'Baseline through Day 84', 'description': 'PK: AUC of MDR-001'}, {'measure': 'Change from Baseline in Fasting Glucose', 'timeFrame': 'Baseline through Day 84', 'description': 'Change from Baseline in Fasting Glucose'}, {'measure': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of MDR-001', 'timeFrame': 'Baseline through Day 84', 'description': 'PK: Cmax of MDR-001'}, {'measure': 'Change from Baseline in Glycated Hemoglobin (HbA1c)', 'timeFrame': 'Baseline through Day 84', 'description': 'Change from Baseline in HbA1c'}, {'measure': 'Change from Baseline in Body Weight', 'timeFrame': 'Baseline through Day 84', 'description': 'Change from Baseline in Body Weight'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obese Volunteers']}, 'descriptionModule': {'briefSummary': 'To investigate the safety and tolerability after single and multiple ascending doses of MDR-001 Tablets administered orally in healthy participants and obese/ overweight participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who are aged ≥ 18 and ≤ 55 years at the time of signing the informed consent; no gender restriction.\n* Participants with 27 ≤ body mass index (BMI) ≤ 45 kg/m2.\n* For male participants, a waist circumference ≥ 90 cm is required, while female participants ≥ 85 cm.\n\nExclusion Criteria:\n\n* Participants with any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers.\n* Participants with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or those with hereditary diseases that easily induce to medullary thyroid carcinoma.\n* Participants with a history of pancreatitis or symptomatic gallbladder disease.\n* Serum calcitonin \\> ULN at screening.\n* Participants with systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg at screening.\n* Participants with ALT \\>2 × ULN and /or AST \\> 2 × ULN at screening.\n* Participants whose fasting triglycerides \\> 5.7 mmol/L, total cholesterol \\> 7.75 mmol/L, low-density lipoprotein cholesterol \\> 4.9 mmol/L at screening.\n* Participants with abnormal uric acid levels accompanied by clinical symptoms (those without clinical symptoms can be included).\n* Participants with fasting blood glucose levels \\> 7 mmol/L.\n* Participants with creatinine clearance \\< 60 mL/min at screening \\[calculation formula: CLcr: (140 - age) × weight (kg) / \\[72 × 0.0113 × Scr (μmol/L)\\], × 0.85 for females\\].\n* Participants have experienced significant changes in diet or exercise habits or within ≥5% changes in body weight within 3 months prior to screening.\n* Participants with clinically significant ECG abnormality deemed unsuitable participation for study by the investigator; or with ECG QTcF values \\> 450 ms for male participants or \\> 470 ms for female participants.'}, 'identificationModule': {'nctId': 'NCT06778850', 'briefTitle': 'A Phase I/IIa Clinical Study to Assess the Single and Multiple Ascending Doses of MDR-001 Tablets in Healthy Participants and Obese/ Overweight Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'MindRank AI Ltd'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase I/IIa Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of MDR-001 Tablets Administrated Orally in Healthy Participants and Obese/ Overweight Participants', 'orgStudyIdInfo': {'id': 'MDR-001-CN-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MDR-001（SAD）', 'description': 'Single doses of MDR-001 administered orally.', 'interventionNames': ['Drug: MDR-001']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo (SAD)', 'description': 'Placebo administered orally.', 'interventionNames': ['Drug: palcebo']}, {'type': 'EXPERIMENTAL', 'label': 'MDR-001 (MAD)', 'description': 'Multiple doses of MDR-001 administered orally.', 'interventionNames': ['Drug: MDR-001']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo (MAD)', 'description': 'Placebo administered orally.', 'interventionNames': ['Drug: palcebo']}], 'interventions': [{'name': 'MDR-001', 'type': 'DRUG', 'description': 'Oral administration of small molecule MDR-001 tablets', 'armGroupLabels': ['MDR-001 (MAD)', 'MDR-001（SAD）']}, {'name': 'palcebo', 'type': 'DRUG', 'description': 'Administered orally placebo', 'armGroupLabels': ['Placebo (MAD)', 'Placebo (SAD)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanhua Ding', 'role': 'CONTACT'}, {'name': 'Guixia Wang', 'role': 'CONTACT'}], 'facility': 'The first hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Ruowen Guo', 'role': 'CONTACT', 'email': 'ruowen.guo@mindrank.cn', 'phone': '+86 0571-85233836'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MindRank AI Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}