Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-25 @ 8:11 PM
Study NCT ID:
NCT06556966
Status:
COMPLETED
Last Update Posted:
2025-05-29
First Post:
2024-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Assessing the Safety and Tolerability of LY03020 in Chinese Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-23', 'studyFirstSubmitDate': '2024-08-13', 'studyFirstSubmitQcDate': '2024-08-13', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quantitatively determine the concentration of LPM787000048 and major metabolites (if applicable) in urine and calculate the cumulative excretion ratio in urine.', 'timeFrame': 'up to144 hours', 'description': 'One dose group will be selected for metabolite identification.'}], 'primaryOutcomes': [{'measure': 'Frequency of adverse events (AEs)', 'timeFrame': 'up to144 hours', 'description': 'Percentage of adverse events'}], 'secondaryOutcomes': [{'measure': 'Maximum observed concentration (Cmax) of LPM787000048 in plasma', 'timeFrame': 'up to144 hours', 'description': 'Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.'}, {'measure': 'Time to maximum observed concentration (Tmax) of LPM787000048 in plasma', 'timeFrame': 'up to144 hours', 'description': 'Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.'}, {'measure': 'Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma', 'timeFrame': 'up to144 hours', 'description': 'Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.'}, {'measure': 'Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma', 'timeFrame': 'up to144 hours', 'description': 'Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.'}, {'measure': 'Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma', 'timeFrame': 'up to144 hours', 'description': 'Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.'}, {'measure': 'Apparent volume of distribution（Vz/F） of LPM787000048 in plasma', 'timeFrame': 'up to144 hours', 'description': 'Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.'}, {'measure': 'Apparent total body clearance (CL/F) of LPM787000048 from plasma', 'timeFrame': 'up to144 hours', 'description': 'Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia', "Alzheimer's Disease Psychosis"]}, 'descriptionModule': {'briefSummary': 'This is a single-center, randomized, double-blind, placebo-controlled, ascending single oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects.', 'detailedDescription': 'The study will set 2.5mg, 5mg, 10mg, 20mg, 40mg, 60mg, 80mg and 100mg, a total of 8 dose groups. Qualified subjects were enrolled in site at D-1 ( 1 day before administration ) and randomized.The subjects should fast for at least 10 hours before medication administration, with no restrictions on water intake. The subjects will be required to orally take LY03020 or a placebo on an empty stomach upon waking on D1 (the day of medication administration). From D1 to D7, they will undergo safety assessments and PK biological sample collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects sign informed consent voluntarily.\n* Male or female aged 18 to 45 years.\n* Body weight ≥ 50.0 kg for male and ≥ 45.0 kg for female, and male or female greater than or equal to 18.5 but less than 26.0 kg/m2 of body mass index (BMI).\n\nExclusion Criteria:\n\n* Subjects have any clinically significant medical condition or chronic disease.\n* Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure,or angle-closure glaucoma.Subjects have a abnormal and clinically significant test for ophthalmic examination during screening.\n* Subjects with condition that may interfere with the drug absorption, distribution, metabolism and excretion significantly.\n* Subjects had a history of surgery within 3 months prior to administration, or had not recovered, or have a surgical plan during the study.\n* Subjects have any clinically significant abnormal vital signs, laboratory values, and ECGs.\n* Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration.\n* Subjects have a history of allergic diseases, or allergic to any substance contained in the formulation\n* Subjects have a positive test for HBsAg, HCV-Ab, HIV-Ab, or syphilis serum reaction.'}, 'identificationModule': {'nctId': 'NCT06556966', 'briefTitle': 'A Study Assessing the Safety and Tolerability of LY03020 in Chinese Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Luye Pharma Group Ltd.'}, 'officialTitle': 'A Phase Ⅰ, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Study to Assess the Safety, Tolerability, and Pharmacokinetics of LPM787000048 Maleate Sustained-release Tablet (LY03020) in Chinese Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'LY03020/CT-CHN-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY03020', 'description': 'Subjects will take single-dose LY03020 on Day 1', 'interventionNames': ['Drug: LY03020']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects will take single-dose Placebo on Day 1', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY03020', 'type': 'DRUG', 'otherNames': ['LPM787000048 Maleate sustained-release tablet'], 'description': 'LY03020 for one single dose', 'armGroupLabels': ['LY03020']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo of LPM787000048 Maleate sustained-release tablet'], 'description': 'Placebo for one single dose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing AnDing Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Gang Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing AnDing Hospital Capital Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luye Pharma Group Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}