Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-30 @ 2:59 AM
Study NCT ID:
NCT05930704
Status:
UNKNOWN
Last Update Posted:
2023-07-17
First Post:
2023-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2025-04-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-13', 'studyFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2023-06-26', 'lastUpdatePostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'From day 1 up to 9 months'}], 'secondaryOutcomes': [{'measure': 'Maximum observed concentration of SHR-2017 (Cmax)', 'timeFrame': 'Day 1 pre-dose up to Day 253'}, {'measure': 'Area under the serum concentration time curve from time 0 to time of last quantifiable serum concentration (AUC0-t) of SHR-2017', 'timeFrame': 'Day 1 pre-dose up to Day 253'}, {'measure': 'Time to maximum observed concentration (Tmax) of SHR-2017', 'timeFrame': 'Day 1 pre-dose up to Day 253'}, {'measure': 'Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (uNTx/Cr)', 'timeFrame': 'Baseline up to Day 253'}, {'measure': 'Percent change from baseline in serum Type I Collagen Carboxy-terminal Peptide (CTX)', 'timeFrame': 'Baseline up to Day 253'}, {'measure': 'Percent change from baseline in Intact Parathyroid Hormone (iPTH)', 'timeFrame': 'Baseline up to Day 253'}, {'measure': 'Percent change from baseline in Bone-Specific Alkaline Phosphatase (BALP)', 'timeFrame': 'Baseline up to Day 253'}, {'measure': 'Number of subjects who developed SHR-2017 antidrug antibodies (ADA)', 'timeFrame': 'Baseline up to Day 253'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The primary objective was to evaluate the safety and tolerability of SHR-2017 after a single subcutaneous (SC) injection in postmenopausal women'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Postmenopausal women ages ≥ 50 years.\n2. Body weight≥45 kg, body mass index (BMI) of 18.0 to 29.0 kg/m2 (inclusive).\n3. Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).\n\nExclusion Criteria:\n\n1. History of malignancy.\n2. Menopause due to simple hysterectomy.\n3. Subjects with poor blood pressure control.\n4. Subjects with positive tests for infectious diseases.\n5. Have a history of diseases related to bone metabolism.\n6. Use of drugs that may affect bone metabolism before administration.\n7. Have a history of alcoholism, medical abuse, or drug use, or have a positive alcohol breath test or drug abuse screening.\n8. Female who are pregnant or breastfeeding.\n9. Unable to tolerate venipunctures or have a history of fainting needles and blood.\n10. Other reasons that the investigator consider it inappropriate to participate in the trial.'}, 'identificationModule': {'nctId': 'NCT05930704', 'briefTitle': 'Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection in Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection Administered Subcutaneously to Postmenopausal Women', 'orgStudyIdInfo': {'id': 'SHR-2017-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-2017 injection', 'interventionNames': ['Drug: SHR-2017 injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SHR-2017 injection', 'type': 'DRUG', 'description': 'Randomized participants of multiple dose cohorts will receive a single subcutaneous dose of SHR-2017 injection.', 'armGroupLabels': ['SHR-2017 injection']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Randomized participants will receive a single SC injection dose of matching placebo.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250000', 'city': 'Jinan', 'state': 'Shangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Zhao', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yuanyuan Huang', 'role': 'CONTACT', 'email': 'yuanyuan.huang@hengrui.com', 'phone': '0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}