Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT05130567
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-03
First Post:
2021-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of LP-128 Capsules in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2021-11-09', 'studyFirstSubmitQcDate': '2021-11-21', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration-time curve (AUC) of LP-128', 'timeFrame': 'Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively', 'description': 'Plasma samples were collected at different points for pharmacokinetic analysis'}, {'measure': 'Apparent terminal phase half-life (T1/2) of LP-128', 'timeFrame': 'Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively', 'description': 'Plasma samples were collected at different points for pharmacokinetic analysis'}, {'measure': 'Maximum observed plasma concentration (Cmax) of LP-128', 'timeFrame': 'Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively', 'description': 'Plasma samples were collected at different points for pharmacokinetic analysis'}, {'measure': 'Adverse events of LP-128', 'timeFrame': 'Up to 28 days', 'description': 'The incidence and severity of adverse events as assessed by NCI CTCAE v5.0.'}], 'secondaryOutcomes': [{'measure': 'Excretion of LP-128 in urine', 'timeFrame': 'Up to 4 days', 'description': 'Urine samples will be collected at different points for pharmacokinetic analysis'}, {'measure': 'Excretion of LP-128 in feces', 'timeFrame': 'Up to 4 days', 'description': 'feces samples will be collected at different points for pharmacokinetic analysis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis b']}, 'descriptionModule': {'briefSummary': 'A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of LP-128 Capsules After Single- and Multiple-Dose in Healthy Subjects', 'detailedDescription': 'This trial includes single dose and multiple dose phases. The single-dose phase included six dose cohorts. Based on the safety and pharmacokinetic results of single-dose study, approximately 2 doses will be selected to conduct multiple-dose study. The primary study objectives are to evaluate the safety, tolerability, and pharmacokinetic characteristics of LP-128 capsules in healthy subjects after single and multiple dosing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects have no history of serious digestive system, central nervous system, cardiovascular system, kidney, respiratory system, metabolism and endocrine, skeletal and muscular system, blood system disease and cancer\n* Subjects (including partners) are willing to take effective contraception measures during study and within 3 months after last dose\n* Male and female healthy subjects aged 18 to 55 years old\n* Male subjects weigh ≥ 50 kg, and female subjects weigh ≥ 45 kg\n* Subjects able to understand and comply with study requirements\n* Willing to sign the informed consent and fully understand the content, process and possible adverse reactions of the trial\n\nExclusion Criteria:\n\n* Abnormal vital signs, physical examination or laboratory tests with clinical significance\n* Abnormal ECG, chest X-ray, abdominal ultrasound or echocardiography with clinical significance\n* Positive screening for viral hepatitis, HIV and syphilis\n* Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug; or subjects who have consumed tea or alcohol-containing food product within 24hrs before administration the study drug\n* Subjects who have a history of dysphagia or condition may affect drug absorption, distribution, metabolism and excretion\n* Female subjects are breastfeeding or pregnant\n* Subjects who have a history of drug/alcohol/tobacco abuse\n* Subjects who have had a blood donation or massive blood loss within three months before screening; or had major surgery within six months before screening\n* Subjects who have participated in other clinical trial within three months before screening\n* Subjects have special dietary requirements or cannot tolerate a standard meal\n* Subjects who are not suitable for this trial based on the assessment of investigator'}, 'identificationModule': {'nctId': 'NCT05130567', 'briefTitle': 'A Study of LP-128 Capsules in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangzhou Lupeng Pharmaceutical Company LTD.'}, 'officialTitle': 'A Randomized Study of LP-128 Capsules vs. Placebo to Evaluate Safety, Tolerability and Pharmacokinetics in Healthy Subjects', 'orgStudyIdInfo': {'id': 'LP-128-CN101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-dose Experimental Group', 'description': 'LP-128 capsule will be adminstrated one time at doses up to 240mg', 'interventionNames': ['Drug: LP-128 capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Single-dose Control Group', 'description': 'Placebo capsule will be adminstrated one time at doses up to 240mg', 'interventionNames': ['Other: Matching Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Multi-dose Experimental Group', 'description': 'LP-128 capsule will be adminstrated once daily, for up to 14 days', 'interventionNames': ['Drug: LP-128 capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Multi-dose Control Group', 'description': 'Placebo capsule will be adminstrated once daily, for up to 14 days', 'interventionNames': ['Other: Matching Placebo']}], 'interventions': [{'name': 'LP-128 capsules', 'type': 'DRUG', 'otherNames': ['NWP-1080'], 'description': 'Oral dosing with LP-128 capsules', 'armGroupLabels': ['Multi-dose Experimental Group', 'Single-dose Experimental Group']}, {'name': 'Matching Placebo', 'type': 'OTHER', 'description': 'Oral dosing with placebo capsules to match LP-128 capsules.', 'armGroupLabels': ['Multi-dose Control Group', 'Single-dose Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'NanFang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Chongyuan Xu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital of Nanfang Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Lupeng Pharmaceutical Company LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}