Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2026-02-21 @ 2:55 PM
Study NCT ID:
NCT04730050
Status:
UNKNOWN
Last Update Posted:
2021-11-24
First Post:
2021-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic Characteristics of TT-01025-CL in Healthy Subjects
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': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-23', 'studyFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2021-01-25', 'lastUpdatePostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'up to 7 days post-dose'}, {'measure': 'AUC', 'timeFrame': 'up to 7 days post-dose'}, {'measure': 'Terminal half-life', 'timeFrame': 'up to 7 days post-dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To assess the safety, tolerability and pharmacokinetic characteristics of TT-01025 in healthy male subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent must be obtained before any assessment is performed.\n* Age ≥ 18 years and ≤ 55 years, male or female.\n* Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and weighs at least 50 kg.\n* No clinically significant findings in medical examination, including physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory tests.\n* Male participant and his female spouse/partner who is of childbearing potential agree to use highly effective contraception\\* consisting of two forms of birth control (at least one of which must be a barrier method) from signing of informed consent throughout the study period and for 90 days after final study drug administration.\n* A female subject of childbearing potential who is sexually active agrees to use highly effective contraception\\* consisting of two forms of birth control (at least one of which must be a barrier method) from signing of informed consent throughout the duration of the study period and for 90 days after last study drug administration. If the next menstrual period is delayed, a pregnancy test will be required for exclusion of pregnancy.\n\n * Highly effective contraception is defined as:\n\n * Established use of oral, injected, or implanted hormonal methods of contraception\n * Placement of an intrauterine device or intrauterine system\n * Barrier methods of contraception: condom with spermicidal foam, gel, film, cream, suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, gel, film, cream, or suppository\n* Able to understand and sign informed consent and to comply with the protocol\n\nExclusion Criteria:\n\n* Any history of clinically serious disease.\n* Any active or unstable clinically significant medical condition as judged by the investigator.\n* Subject has abnormal Screening findings or Day -2 laboratory value that suggest a clinically significant underlying disease.\n* Hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes.\n* Received any investigational drug within 30 days or 5x T1/2 whichever is longer before the Screening.\n* Participants who have undergone major surgery ≤ 2 months prior to start study drug.\n* Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality in clinical test, including but not limited to any of the following at Screening and\n\nCheck-in, repeat testing is allowed for verification, at the discretion of the Investigator:\n\n* Heart rate \\< 45 beats per minute (bpm) or \\> 90 bpm (taken during blood pressure measurement).\n* Systolic blood pressure (SBP) \\< 90 mmHg or \\> 140 mmHg; diastolic blood pressure (DBP) \\< 50 mmHg or \\> 90 mmHg.\n* Average of the 3 QT intervals corrected using Fridericia's formula (QTcF) \\> 450 milliseconds.\n* Second degree or higher Atrioventricular block on ECG\n* Estimated glomerular filtration rate (eGFR) \\< 90 ml/min/1.73m2\n\n * Impaired renal function or abnormal liver enzymes at baseline, including but not limited to:\n* Alanine aminotransferase (ALT) \\> upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) \\> ULN\n* Estimated glomerular filtration rate (eGFR) \\< 90 ml/min/1.73m2\n\n * Women who are pregnant or lactating, or intending to become pregnant before, during or within 90 days after exit from this study.\n * Women with baseline FSH ≥40mIU/ml\n * Participant who has had a loss of more than 100 mL blood (e.g., a blood donation) within 2 months before study drug administration, or has received any blood, plasma, or platelet transfusions within 3 months before Check-in, or plans to donate blood, ova or sperm during the study or within 3 months after the study.\n * Participant who has a known history of, or a positive test result for, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) types 1 or 2 at screening.\n * Participant who has used prescription or over-the-counter (OTC) medication (other than ≤2 g/day paracetamol \\[acetaminophen\\] or ≤800 mg/day ibuprofen), vitamins, or herbal remedies, within 7 days or 5 half-lives before study drug administration, whichever is longer.\n * Participant who has a history of alcohol abuse (defined as an alcohol intake more than 21 units per week) or a history of drug abuse within the 6 months before study drug administration, or a history of substance abuse deemed significant by the investigator. A unit of alcohol is defined as 240 mL of beer, 120 mL of wine, or 20 mL of spirits.\n * Participant who smokes cigarettes or uses other nicotine-containing products (e.g., vape, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers), has done so in the 3 months prior to screening.\n * Consumption of caffeine or xanthine-containing food or beverages from at least 72 hours prior to Check-in to the clinical research unit until at least 24 hours after last drug administration\n * Participant who has a positive test for alcohol or drugs of abuse (amphetamines, barbiturates, benzodiazepines, MDMA, oxycodone, phencyclidine, methamphetamine, tricyclic antidepressants, opiates, methadone, cocaine, cannabinoids, amphetamines, or cotinine) at Screening or Check-in.\n * Subject is unable to complete this study for other reasons or the Investigator believes that he or she should be excluded.\n * Participant who has a positive swab test of COVID-19 from Screening or Check-in testing."}, 'identificationModule': {'nctId': 'NCT04730050', 'briefTitle': 'A Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic Characteristics of TT-01025-CL in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Chem'}, 'officialTitle': 'A Phase I, First-In-Human, Randomized, Double Blind, Placebo Controlled, Single Ascending-Dose and Multi Ascending Dose Study of TT-01025-CL in Healthy Subjects', 'orgStudyIdInfo': {'id': 'TT01025US01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug: TT-01025-CL', 'description': 'TT-01025-CL', 'interventionNames': ['Drug: TT-01025-CL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Drug: Placebo', 'description': 'Placebo of TT-01025-CL', 'interventionNames': ['Drug: TT-01025-CL']}], 'interventions': [{'name': 'TT-01025-CL', 'type': 'DRUG', 'description': 'Oral tablet', 'armGroupLabels': ['Drug: Placebo', 'Drug: TT-01025-CL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89113', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Las Vegas Clinical Research Unit', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Chem', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}