Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-01 @ 5:47 AM
Study NCT ID:
NCT07143318
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First-in-Human Single and Multiple Dose of KLA578-1 for Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events (AEs)', 'timeFrame': 'Up to day 13'}], 'secondaryOutcomes': [{'measure': 'PK parameter Cmax', 'timeFrame': 'single dose：up to Day 6 ; multiple doses: up to Day 8', 'description': 'Maximum peak plasma concentration (Cmax) after single dose and in a steady state after multiple doses'}, {'measure': 'PK parameter Tmax', 'timeFrame': 'single dose：up to Day 6 ; multiple doses: up to Day 8', 'description': 'Time of Cmax (Tmax) after single dose and in a steady state after multiple doses'}, {'measure': 'PK parameter Cmin,ss', 'timeFrame': 'multiple doses: up to Day 1', 'description': 'The trough concentration observed during the drug administration interval in a steady state (Cmin,ss) after multiple doses'}, {'measure': 'PK parameter AUC0-t', 'timeFrame': 'single dose：up to Day 6 ; multiple doses: up to Day 8', 'description': 'Area under the concentration-time curve (AUC0-t) from time zero to time "t" after single dose and in a steady state after multiple doses'}, {'measure': 'PK parameter AUC0-∞', 'timeFrame': 'single dose：up to Day 6 ; multiple doses: up to Day 8', 'description': 'AUC from time zero to infinity (AUC0-∞) after single dose and in a steady state after multiple doses'}, {'measure': 'PK parameter AUCtau,ss', 'timeFrame': 'multiple doses: up to Day 1', 'description': 'AUC for the drug administration interval in a steady state (AUCtau,ss) after multiple doses'}, {'measure': 'PK parameter t1/2', 'timeFrame': 'single dose：up to Day 6 ; multiple doses: up to Day 8', 'description': 'Terminal-phase elimination half-life (t1/2) after single dose and in a steady state after multiple doses'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single and multiple doses of KLA578-1 for injection in healthy volunteers', 'detailedDescription': '"The study will be carried out in 2 parts. Part 1: This is a open-label, single ascending dose (SAD) escalation study with a total of 3 dose groups, i.e., Groups 1 to 3. There are a total of 12 volunteers in each group with a similar male to female ratio. Groups 1 and 3 are single-arm study, all volunteers will receive the experimental drug ""KLA578-1 for Injection"" ; Group 2 is a randomized, two-treatment, two-period, crossover study, 12 volunteers will be randomized to TR sequence or RT sequence with 6 volunteers in each sequence. The experimental drug ""KLA578-1 for injection"" will be administered in the TR sequence of Period 1, the control drug ""Etopcoxib Tablets"" will be administered to the RT sequence. After 7 days of washing, the control drug ""Etocoxib Tablets"" will be administered in the TR sequence, and the experimental drug ""KLA578-1 for Injection"" will be administered in the RT sequence.\n\nPart 2: This is a open-label, single-arm multiple dose study. A dose group is temporarily set up, with a total of 12 volunteers enrolled, and the male-to-female ratio will be similar. Volunteers will receive the experimental drug ""KLA578-1 for Injection"" 120 mg once daily (every 24 h ± 2 min with reference to the dosing time on D1) under fasting conditions (fasting for at least 10 hours) from D1 to D5; Drinking water is prohibited from 1 h before each dose to 1 h postdose, and fasted within 4 hours after dosing on D1 and D5."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Health Volunteers (Age: 18\\~45 years);\n2. Body Weight: Male≥50.0kg, Female≥45.0kg; 19.0 ≤BMI≤ 26.0;\n3. There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, laboratory tests;\n4. Heart rate ≥ 60 bpm and pulse ≥ 60 beats/min.\n\nExclusion Criteria:\n\n1. Allergy or Drug hypersensitivity;\n2. Clinically significant Medical History;\n3. Gastrointestinal ulcers or gastrointestinal bleeding;\n4. History of any surgery within 4 weeks;\n5. History of any Medication within 14 days;\n6. History of any inducers or inhibitors of major CYP450 enzymes within 30 days;\n7. History of any clinical study within 3 months;\n8. History of any vaccine within 1 month;\n9. History of any drug abuse;\n10. Tablet dysphagia;\n11. Needle sickness, Hematosickness;\n12. Massive blood loss (\\> 200 mL) in the past 3 months;\n13. Female volunteers are pregnant or lactating;\n14. History of unprotected sex within 2 weeks;\n15. Special requirements for diet;\n16. Heavy smoker ( more than 3 cigarettes/day) within 3 months;\n17. History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months;\n18. Heavy caffeine intake;\n19. History of grapefruit, xanthine-rich foods intake within 7 days;\n20. Positive alcohol test;\n21. Positive drugs of abuse test result.'}, 'identificationModule': {'nctId': 'NCT07143318', 'briefTitle': 'First-in-Human Single and Multiple Dose of KLA578-1 for Injection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.'}, 'officialTitle': 'A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of KLA578-1 for Injection in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'KLA578-1-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KLA578-1 60mg', 'description': '12 volunteers receive KLA578-1 for injection 60mg', 'interventionNames': ['Drug: KLA578-1 for injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'KLA578-1 120mg', 'description': 'Period 1, 6 volunteers receive KLA578-1 for injection 120mg → 6 volunteers receive Etopcoxib Tablets 120mg; Period 2, 6 volunteers receive Etopcoxib Tablets 120mg → 6 volunteers receive KLA578-1 for injection 120mg', 'interventionNames': ['Drug: KLA578-1 for injection', 'Drug: Etopcoxib Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'KLA578-1 240mg', 'description': '12 volunteers receive KLA578-1 for injection 240mg', 'interventionNames': ['Drug: KLA578-1 for injection']}, {'type': 'EXPERIMENTAL', 'label': 'multiple doses of KLA578-1 for injection', 'description': '12 volunteers receive KLA578-1 for injection 120mg over 5 consecutive days.', 'interventionNames': ['Drug: KLA578-1 for injection']}], 'interventions': [{'name': 'KLA578-1 for injection', 'type': 'DRUG', 'description': 'Intravenous injection, single dose', 'armGroupLabels': ['KLA578-1 120mg', 'KLA578-1 240mg', 'KLA578-1 60mg', 'multiple doses of KLA578-1 for injection']}, {'name': 'Etopcoxib Tablets', 'type': 'DRUG', 'description': 'P.O., single dose', 'armGroupLabels': ['KLA578-1 120mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '611130', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guoping Yang', 'role': 'CONTACT', 'email': 'ygp9880@163.com', 'phone': '13974817168'}, {'name': 'Chengxian Guo', 'role': 'CONTACT', 'email': 'gchxyy@163.com', 'phone': '15580992599'}], 'facility': 'The Third Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Wei Qi', 'role': 'CONTACT', 'email': 'qiw@kelun.com', 'phone': '028-82339360'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan Kelun Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}