Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
Study NCT ID:
NCT07171034
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I Study of KLA318-2 Nanocrystal Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-08-28', 'studyFirstSubmitQcDate': '2025-09-05', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events (AEs)', 'timeFrame': 'UP to Day 14'}], 'secondaryOutcomes': [{'measure': 'PK parameter Cmax', 'timeFrame': 'UP to Day 3', 'description': 'Maximum peak plasma concentration (Cmax) after single dose and in a steady state after multiple doses'}, {'measure': 'PK parameter Tmax', 'timeFrame': 'UP to Day 3', 'description': 'Time of Cmax (Tmax) after single dose and in a steady state after multiple doses'}, {'measure': 'PK parameter AUC0-t', 'timeFrame': 'UP to Day 3', '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': 'UP to Day 3', 'description': 'AUC from time zero to infinity (AUC0-∞) after single dose and in a steady state after multiple doses'}, {'measure': 'PK parameter t1/2', 'timeFrame': 'UP to Day 3', '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 Participants']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety,tolerability and pharmacokinetics properties of KLA318-2 Nanocrystal Injection after a single intravenous injection in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Health participants (Age: 18\\~45 years);\n2. Body Weight: Male≥50.0kg, Female≥45.0kg; 18.5 ≤BMI≤ 28.0;\n3. Normal ECG, showing no clinically relevant deviations, as judged by the investigator.\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 drug interactions with celecoxib 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, or positive drugs of abuse test result;\n10. Subjects with difficult venous blood collection/intolerance to venipuncture, or with a history of needle phobia/blood phobia;\n11. Massive blood loss (\\> 200 mL) in the past 3 months;\n12. Special requirements for diet;\n13. Heavy smoker ( more than 3 cigarettes/day) within 3 months;\n14. History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months, or positive alcohol test;\n15. Heavy caffeine intake;\n16. History of grapefruit, xanthine-rich foods intake within 7 days;\n17. Female participants are pregnant or lactating;\n18. History of unprotected sex within 2 weeks.'}, 'identificationModule': {'nctId': 'NCT07171034', 'briefTitle': 'A Phase I Study of KLA318-2 Nanocrystal 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 KLA318-2 Nanocrystal Injection in Healthy Participants', 'orgStudyIdInfo': {'id': 'KLA318-2-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KLA318-2 Nanocrystal Injection 60mg', 'description': '12 participants receive KLA318-2 60mg', 'interventionNames': ['Drug: KLA318-2 Nanocrystal Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'KLA318-2 Nanocrystal Injection 120mg', 'description': 'Period 1, 6 participants receive KLA318-2 120mg → 6 participants receive Celebrex Capsule 200mg; Period 2, 6 participants receive Celebrex Capsule 200mg → 6 participants receive KLA318-2 120mg', 'interventionNames': ['Drug: KLA318-2 Nanocrystal Injection', 'Drug: Celebrex Capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'KLA318-2 Nanocrystal Injection 180mg', 'description': 'Period 1, 6 participants receive KLA318-2 180mg → 6 participants receive Celebrex Capsules 400mg; Period 2, 6 participants receive Celebrex Capsules 400mg → 6 participants receive KLA318-2 180mg', 'interventionNames': ['Drug: KLA318-2 Nanocrystal Injection', 'Drug: Celebrex Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'KLA318-2 Nanocrystal Injection 240mg', 'description': '12 participants receive KLA318-2 240mg', 'interventionNames': ['Drug: KLA318-2 Nanocrystal Injection']}], 'interventions': [{'name': 'KLA318-2 Nanocrystal Injection', 'type': 'DRUG', 'description': 'Intravenous injection, single dose', 'armGroupLabels': ['KLA318-2 Nanocrystal Injection 120mg', 'KLA318-2 Nanocrystal Injection 180mg', 'KLA318-2 Nanocrystal Injection 240mg', 'KLA318-2 Nanocrystal Injection 60mg']}, {'name': 'Celebrex Capsule', 'type': 'DRUG', 'description': 'P.O., single dose', 'armGroupLabels': ['KLA318-2 Nanocrystal Injection 120mg', 'KLA318-2 Nanocrystal Injection 180mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250014', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Zhao', 'role': 'CONTACT', 'email': 'zhao4wei2@hotmail.com', 'phone': '0531-89268212'}], 'facility': 'The first affiliated hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Wei Qi', 'role': 'CONTACT', 'email': 'qiw@kelun.com', 'phone': '028-82339360'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunan Kelun Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}