Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-02-21 @ 2:54 PM
Study NCT ID:
NCT04592835
Status:
UNKNOWN
Last Update Posted:
2020-10-19
First Post:
2020-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety, Tolerability and Pharmacokinetic Properties of DWRX2003
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10-19', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-16', 'studyFirstSubmitDate': '2020-10-07', 'studyFirstSubmitQcDate': '2020-10-16', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'follow-up 35 days after dosing', 'description': 'Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)'}], 'secondaryOutcomes': [{'measure': 'To assess PK parameters of niclosamide injectable (DWRX2003) through Cmax', 'timeFrame': 'at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28', 'description': 'Measured through Maximum (peak) plasma drug concentration (Cmax)'}, {'measure': 'To assess PK parameters of niclosamide injectable (DWRX2003) through tmax', 'timeFrame': 'at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28', 'description': 'Time to reach Cmax following IP administration (tmax)'}, {'measure': 'To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-last', 'timeFrame': 'at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28', 'description': 'Area under the curve from zero to time of last measurable concentration (AUC0-last)'}, {'measure': 'To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-∞', 'timeFrame': 'at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28', 'description': 'Area under the curve from zero to infinity (AUC0-∞)'}, {'measure': 'To assess PK parameters of niclosamide injectable (DWRX2003) through t1/2', 'timeFrame': 'at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28', 'description': 'Elimination half-life (t1/2)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Patients']}, 'descriptionModule': {'briefSummary': 'This study is designed to assess the safety, tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy males and females, between 18 and 65 years of age, inclusive, at time of signing the Informed Consent Form (ICF).\n2. Body mass index between 18.0 lesser than or equal to Body Mass Index (BMI) lesser than or equal to 32 at Screening, with a minimum weight of 50 kg (inclusive).\n3. Willing to sign ICF on a voluntary basis and to voluntarily participate in the study, after being fully informed of and completely understanding this study, prior to any Screening procedure being undertaken\n\nExclusion Criteria:\n\n1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;\n2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note participants with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee).\n3. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee)'}, 'identificationModule': {'nctId': 'NCT04592835', 'briefTitle': 'To Evaluate the Safety, Tolerability and Pharmacokinetic Properties of DWRX2003', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled, Single-ascending Dose Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Following Intramuscular Administration in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'DW_DWJ1516101_Australia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 (288mg)', 'description': '72 mg/0.3 mL x 4 injection sites', 'interventionNames': ['Drug: DWRX2003']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 (576 mg)', 'description': '144 mg/0.6 mL x 4 injection sites', 'interventionNames': ['Drug: DWRX2003']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 (960 mg)', 'description': '216 mg/1.0 mL x 4 injection sites', 'interventionNames': ['Drug: DWRX2003']}], 'interventions': [{'name': 'DWRX2003', 'type': 'DRUG', 'description': 'Intramuscularly injection at predefined injection sites\n\nDrug: Placebo Intramuscularly injection at predefined injection sites', 'armGroupLabels': ['Cohort 1 (288mg)', 'Cohort 2 (576 mg)', 'Cohort 3 (960 mg)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novotech (Australia) Pty Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}