Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-01 @ 12:30 AM
Study NCT ID:
NCT06883695
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-12
First Post:
2025-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ⅰ Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events (AEs)', 'timeFrame': 'From screening period up to day 113.'}], 'secondaryOutcomes': [{'measure': 'Area under the concentration-time curve from time 0 to the last time point after SHR-3045 administration (AUC0-last).', 'timeFrame': 'Post-dose at day 1 to day 113.'}, {'measure': 'Area under the concentration-time curve from time 0 to infinity after SHR-3045 administration (AUC0-inf).', 'timeFrame': 'Post-dose at day 1 to day 113.'}, {'measure': 'Maximum observed concentration of SHR-3045 (Cmax).', 'timeFrame': 'Post-dose at day 1 to day 113.'}, {'measure': 'Time to maximum observed concentration of SHR-3045 (Tmax).', 'timeFrame': 'Post-dose at day 1 to day 113.'}, {'measure': 'Clearance of SHR-3045 (CL).', 'timeFrame': 'Post-dose at day 1 to day 113.'}, {'measure': 'Terminal elimination half-life of SHR-3045 (t1/2).', 'timeFrame': 'Post-dose at day 1 to day 113.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3045 in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects with ability to understand the trial procedures and possible adverse events, voluntary participation in the trial.\n2. Subjects who can provide written informed consent.\n3. Males or females aged 18-55 years (both inclusive).\n4. Males with body weight ≥ 50 kg, or females with body weight ≥ 45 kg.\n5. No clinically significant abnormalities in the medical history, general physical examinations, vital signs and laboratory tests.\n\nExclusion Criteria:\n\n1. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening.\n2. Known or suspected history of drug abuse.\n3. Addiction to tobacco and alcohol.\n4. Individuals who are unable to adhere to the dietary requirements of this trial during the study period.\n5. Judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.'}, 'identificationModule': {'nctId': 'NCT06883695', 'briefTitle': 'A Phase Ⅰ Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangdong Hengrui Pharmaceutical Co., Ltd'}, 'officialTitle': 'A Phase Ⅰ, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'SHR-3045-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-3045 Group', 'interventionNames': ['Drug: SHR-3045 Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'SHR-3045 Placebo Group', 'interventionNames': ['Drug: SHR-3045 Placebo Injection']}], 'interventions': [{'name': 'SHR-3045 Injection', 'type': 'DRUG', 'description': 'SHR-3045 injection.', 'armGroupLabels': ['SHR-3045 Group']}, {'name': 'SHR-3045 Placebo Injection', 'type': 'DRUG', 'description': 'SHR-3045 placebo injection.', 'armGroupLabels': ['SHR-3045 Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200080', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai General Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Hengrui Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}