Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT01992367
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2013-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1, Randomised Double Blinded Placebo Controlled Study of ASLAN003
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-31', 'studyFirstSubmitDate': '2013-11-13', 'studyFirstSubmitQcDate': '2013-11-19', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '6 months', 'description': 'Safety assessments will include 12 lead ECGs, physical examiniation, vital signs measurements, pulse rate, RR, body temperature, clinical laboratory assessments and recording of adverse events'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a single-centre, placebo-controlled, randomised, double-blind study to evaluate the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of ASLAN003 in healthy subjects', 'detailedDescription': 'This is a single-centre, placebo-controlled, randomised, double-blind study involving SAD and MAD of ASLAN003 in healthy subjects.\n\nThe study is divided into two parts:\n\n* Part A: SAD cohorts and 1 cohort to assess food effect of ASLAN003 PK.\n* Part B: MAD cohorts with one cohort being of healthy elderly subjects.\n\nThere will be a sentinel pair of subjects for each of SAD Cohorts 1, 2 and 3 who will be dosed first and then the same dose will be given to the rest of the subjects in the respective cohorts.\n\nIn addition, 8 subjects will receive ASLAN003 under both fed and fasted conditions'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The inclusion criteria for all subjects are as follows:\n* are capable of understanding and complying with the requirements of the study and have signed the informed consent form (ICF);\n* are able to communicate well with the Investigator, and understand and comply with the requirements of the study;\n* male subjects aged between 21 and 50 years, inclusive (Part A and Cohorts 5, 6 and 7 of Part B only); male subjects and female subjects of non childbearing potential aged ≥55 years (Cohort 8 of Part B only);\n* body mass index (BMI) in the range of 18 to 30 kg/m2, inclusive;\n* healthy, as determined by pre study medical history, physical examinations, vital sign measurements, electrocardiogram (ECG; 12 lead reporting RR, PR, QRS, corrected QT \\[QTc\\] and QT interval corrected for heart rate using Fridericia's formulas \\[QTcF\\]) recordings with no evidence of clinically relevant medical disorders based on the opinion of the Investigator;\n* whose out-of-normal range clinical laboratory test results are not clinically relevant and are acceptable to the Investigator;\n* male subjects must be willing to use barrier contraception during sexual intercourse, i.e. condoms, even if their partners are post-menopausal, surgically sterile or are using accepted contraceptive methods, from the first day of dose administrations until 3 months after the last dose administration;\n\nExclusion Criteria:\n\n* The exclusion criteria for all subjects are as follows:\n* have participated in a study involving another investigational device or drug study within 90 days prior to randomisation in this study;\n* history of drug hypersensitivity reactions or hypersensitivity to drugs chemically related to the IP;\n* history or evidence of a clinically significant disorder, condition or disease (including, but not limited to, cardiopulmonary, oncologic, autoimmune, immunogenic, renal, metabolic, haematological or psychiatric), that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;\n* existence of any surgical or medical condition which, in the judgement of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the IP;\n* clinically significant history or evidence of any active or suspected bacterial, viral, fungal or parasitic infection within the 30 days prior to randomisation (e.g. common cold, viral syndrome, flu-like symptoms, etc.);\n* active or recent history (within 30 days prior to randomisation) of acute viral infection of the skin (e.g. Herpes simplex, Molluscum contagiosum);\n* active or history of psoriasis, or a first-degree relative with active or history of psoriasis;\n* known history or evidence of active or latent tuberculosis infection (e.g. positive tuberculin skin test showing induration \\>5 mm or positive tuberculin blood test) in absence of previous Bacillus Calmette Guerin vaccination, or recent exposure (within 6 months prior to randomisation in this study) to an individual with active tuberculosis or with intention to travel to a country with a high risk of tuberculosis during the study period (including the follow up period);\n* history of autoimmune disease including but not limited to lupus, rheumatoid arthritis, autoimmune thyroid disease and immune thrombocytopenia;\n* with QT or QTcF values higher than 450 ms at screening;\n* history of regular alcohol consumption (within 6 months prior to randomisation in this study), defined as: an average weekly intake of greater than 21 units or any average daily intake of greater than 3 units. One unit is equivalent to a half pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine;"}, 'identificationModule': {'nctId': 'NCT01992367', 'briefTitle': 'Phase 1, Randomised Double Blinded Placebo Controlled Study of ASLAN003', 'organization': {'class': 'OTHER', 'fullName': 'ASLAN Pharmaceuticals'}, 'officialTitle': 'A Phase 1, Randomised, Double Blind, Placebo Controlled, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of ASLAN003 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'ASLAN003-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo arm', 'interventionNames': ['Drug: ASLAN003 ACTIVE']}, {'type': 'OTHER', 'label': 'ASLAN003', 'description': 'Active drug', 'interventionNames': ['Drug: ASLAN003 ACTIVE']}], 'interventions': [{'name': 'ASLAN003 ACTIVE', 'type': 'DRUG', 'otherNames': ['ASLAN 003 , LAS186323'], 'description': 'This is a single-centre, placebo-controlled, randomised, double-blind study involving SAD and MAD of ASLAN003 in healthy subjects.', 'armGroupLabels': ['ASLAN003', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Please contact ASLAN Pharmaceuticals Pte Ltd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'contact@aslanpharma.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ASLAN Pharmaceuticals', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}