Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:03 AM
Study NCT ID:
NCT07415304
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of ISM4808 in Healthy Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'This is a double-blind study in which participants and investigators are blinded to treatment assignment.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be assigned to receive ISM4808 or placebo in parallel cohorts within single ascending dose (SAD) and multiple ascending dose (MAD) phases. A food effect (FE) assessment will be conducted in a selected dose cohort following an appropriate washout period using the same subjects in the single ascending dose cohorts.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-01-26', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Maximum Observed Serum Concentration (Cmax) of Erythropoietin (EPO)', 'timeFrame': 'SAD cohorts: From Day 1 pre-dose through 72 hours post-dose; MAD cohorts: Day 1 and Day 10', 'description': 'Cmax is the maximum serum concentration observed after dosing. This will be evaluated as part of the pharmacodynamic (PD) assessment of ISM4808'}, {'measure': 'Time to Maximum Observed Serum Concentration (Tmax) of EPO', 'timeFrame': 'SAD cohorts: From Day 1 pre-dose through 72 hours post-dose ; MAD cohorts: Day 1 pre-dose, Day 1 and Day 10', 'description': 'Tmax is the time at which the maximum observed serum concentration (Cmax) is reached, determined directly from the serum concentration-time data'}, {'measure': 'Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of EPO', 'timeFrame': 'SAD cohorts: Pre-dose through 72 hours post-dose ; MAD cohorts: Day 1 and Day 10', 'description': 'AUC0-t will be calculated using the linear-log trapezoidal method'}, {'measure': 'Correlation Between plasma ISM4808 Concentration and Placebo-Corrected Change From Baseline in QTcF Interval', 'timeFrame': 'SAD/food-effect cohorts: From pre-dose (baseline) up to Day 9; MAD cohorts: From pre-dose (baseline) up to Day 18', 'description': 'A Concentration-QT (C-QT) modeling analysis will be performed using plasma ISM4808 concentration data matched with ECG sampling time points. The correlation between the drug concentration and the placebo-corrected change from baseline in QTcF (measured in milliseconds \\[ms\\] via 12-lead Electrocardiogram \\[ECG\\]) will be evaluated using a linear mixed-effects model to estimate the concentration-dependent effect on the QTc interval.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)', 'timeFrame': 'SAD/food-effect cohorts: From first dose up to Day 9; MAD cohorts: From first dose up to Day 18', 'description': 'A TEAE is an adverse event (AE) occurrence in a subject who received study drug whether or not considered related to the study product.\n\nAny adverse event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment is categorized as SAE.\n\nThe number of participants who experience at least one TEAE and SAE will be presented.'}], 'secondaryOutcomes': [{'measure': 'Terminal elimination half-life (t1/2) of ISM4808', 'timeFrame': 'SAD/Food-effect cohorts: Pre-dose through 72 hours post-dose', 'description': 't1/2 is the time required for the plasma concentration of ISM4808 to decrease by half in the terminal phase. It is derived from the terminal slope of the concentration versus time curve'}, {'measure': 'Terminal elimination half-life (t1/2) of ISM4808', 'timeFrame': 'MAD cohorts: Day 1 and Day 10', 'description': 't1/2 is the time required for the plasma concentration of ISM4808 to decrease by half in the terminal phase. It is derived from the terminal slope of the concentration versus time curve'}, {'measure': 'Time to Maximum Observed Plasma Concentration (Tmax) of ISM4808', 'timeFrame': 'SAD/Food-effect cohorts: Pre-dose through 72 hours post-dose', 'description': 'Tmax is the time at which the maximum observed plasma concentration (Cmax) is reached, determined directly from the plasma concentration-time data'}, {'measure': 'Time to Maximum Observed Plasma Concentration (Tmax) of ISM4808', 'timeFrame': 'MAD cohorts: Day 1 and Day 10', 'description': 'Tmax is the time at which the maximum observed plasma concentration (Cmax) is reached, determined directly from the plasma concentration-time data'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of ISM4808', 'timeFrame': 'SAD/Food-effect cohorts: Pre-dose through 72 hours post-dose', 'description': 'Cmax will be derived directly from the plasma concentration-time profiles'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of ISM4808', 'timeFrame': 'MAD cohorts: Day 1 and Day 10', 'description': 'Cmax will be derived directly from the plasma concentration-time profiles'}, {'measure': 'Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of ISM4808', 'timeFrame': 'SAD/Food-effect cohorts: Pre-dose through 72 hours post-dose', 'description': 'AUC0-t will be calculated using the linear-log trapezoidal method'}, {'measure': 'Area Under the Plasma Concentration-Time Curve within a dosing interval (AUC0-tau) of ISM4808', 'timeFrame': 'MAD cohorts: Day 1 and Day 10', 'description': 'AUC0-tau is the area under the plasma concentration-time curve within the specified dosing interval, calculated using the linear-log trapezoidal method'}, {'measure': 'Average Steady-state Plasma Concentration (Cav) of ISM4808', 'timeFrame': 'MAD cohorts: Day 1 and Day 10', 'description': 'Cav will be calculated as AUC 0- tau divided by the dosing interval tau'}, {'measure': 'Amount Excreted into Urine (Ae)of ISM4808', 'timeFrame': 'MAD cohorts: 0-24 hours post dose on Day 10', 'description': 'Ae is the total amount of unchanged drug excreted in the urine'}, {'measure': 'Percentage of dose excreted in urine (Ae%) of ISM4808', 'timeFrame': 'MAD cohorts: 0-24 hours post dose on Day 10', 'description': 'The percentage of the administered dose that is excreted as unchanged drug in the urine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a Phase I, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), food effect, and QTc effects of single and multiple ascending oral doses of ISM4808 in healthy adult subjects.', 'detailedDescription': 'The study consists of two parts, Part 1 includes single ascending dose (SAD) and food effect (FE) assessments, FE assessments will be conducted in a selected dose cohort from the single ascending dose phase, using the same subjects after an appropriate washout period, AND Part 2 includes multiple ascending dose (MAD) evaluations. Safety, PK, PD, and concentration-QTc relationship will be assessed across dose levels.\n\nDose escalation decisions will be based on the review of available safety, tolerability, and pharmacokinetic data by a Safety Monitoring Committee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Able and willing to provide written informed consent and comply with all study procedures.\n\n * Healthy male or female adults aged 18 to 55 years at the time of informed consent.\n * Body mass index (BMI) 19-26 kg/m²; body weight ≥50 kg (males) and ≥45 kg (females).\n * Medically healthy with no clinically significant abnormalities in medical history, physical examination, vital signs, laboratory tests, or 12-lead ECG, as determined by the investigator.\n * Women of childbearing potential and male subjects with partners of childbearing potential must agree to use effective contraception from screening through 3 months after the last dose of investigational product.\n\nExclusion Criteria:\n\n* History or presence of any clinically significant disease (including cardiovascular, neurological, psychiatric, gastrointestinal, hepatic, renal, hematologic, endocrine, or immune disorders) that may interfere with study participation or data interpretation.\n* Personal or family history of clinically significant cardiac disease, including QT prolongation, torsades de pointes, myocardial infarction, heart failure, or sudden cardiac death.\n* Use of medications known to prolong QT/QTc interval or treatment for clinically significant cardiac conditions.\n* Screening 12-lead ECG abnormalities, including QTcF \\>450 ms (males) or \\>470 ms (females), PR interval \\>210 ms, QRS duration \\>110 ms, clinically significant arrhythmias, or uncontrolled hypertension.\n* Participation in another interventional clinical trial or receipt of any investigational drug within 3 months prior to first dosing.\n* Blood donation or significant blood loss (≥400 mL) within 3 months prior to first dosing.\n* Pregnant or breastfeeding women, or positive pregnancy test at screening or prior to dosing.\n* Positive tests for HBsAg, HCV antibody, HIV antibody, or syphilis.\n* History of drug or alcohol abuse, positive drug screen, or inability to abstain from alcohol, nicotine, or prohibited substances during the study.\n* Use of prescription or non-prescription medications, herbal products, supplements, or vaccines within 28 days prior to dosing, unless approved by the investigator.\n* Any condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.'}, 'identificationModule': {'nctId': 'NCT07415304', 'briefTitle': 'A Phase 1 Study of ISM4808 in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'TaiGen Biotechnology Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral ISM4808 in Healthy Adult Subjects in China', 'orgStudyIdInfo': {'id': 'ISM4808-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ISM4808', 'description': 'Participants receive ISM4808 administered orally in single ascending dose and multiple ascending dose regimens.', 'interventionNames': ['Drug: ISM4808']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive matching placebo administered orally in single ascending dose and multiple ascending dose regimens.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ISM4808', 'type': 'DRUG', 'description': 'ISM4808 administered orally as capsules in single ascending dose and multiple ascending dose regimens, with flexible dosing schedules based on emerging safety and pharmacokinetic data.', 'armGroupLabels': ['ISM4808']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo administered orally under the same conditions as ISM4808.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Li-Wen Chang', 'role': 'CONTACT', 'email': 'lwchang@taigenbiotech.com', 'phone': '+886-2-8177-7020 227', 'phoneExt': '1227'}], 'overallOfficials': [{'name': 'Gan Zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xiangya Hospital of Central South University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TaiGen Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'R&G Pharma Studies Co.,Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}