Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2025-12-27 @ 9:52 PM
Study NCT ID:
NCT06992661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-28
First Post:
2025-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Pharmacokinetics and Safety of Single-dose Inhaled ICF004 in Healthy Volunteers and Patients With Interstitial Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-05-19', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-24 hours of blood samples in ILD patients', 'timeFrame': 'Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose', 'description': 'AUC0-24 hours: Area Under the plasma concentration-time Curve from time zero to 24 hours post dose. Plasma pharmacokinetic (PK) parameters of ICF004 in ILD patients.'}], 'secondaryOutcomes': [{'measure': 'AUC0-∞ of blood samples in ILD patients', 'timeFrame': 'Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose', 'description': 'AUC0-∞: Area Under the plasma concentration-time Curve from time zero to infinity. Plasma pharmacokinetic (PK) parameters of ICF004 in ILD patients.'}, {'measure': 'Tmax of blood samples in ILD patients', 'timeFrame': 'Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose', 'description': 'Tmax: Time to reach maximum plasma concentration. Plasma pharmacokinetic (PK) parameters of ICF004 in ILD patients.'}, {'measure': 'Cmax of blood samples in ILD patients', 'timeFrame': 'Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose', 'description': 'Cmax: Peak Plasma Concentration. Plasma pharmacokinetic (PK) parameters of ICF004 in ILD patients.'}, {'measure': 'T1/2 of blood samples in ILD patients', 'timeFrame': 'Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose', 'description': 'T1/2: Half-life. Plasma pharmacokinetic (PK) parameters of ICF004 in ILD patients.'}, {'measure': 'AUC0-24 hours of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients', 'timeFrame': '1 hours, 6 hours, 12 hours, and 24 hours post-dose', 'description': 'AUC0-24 hours: Area Under the BALF concentration-time Curve from time zero to 24 hours post-dose. Lung pharmacokinetic (PK) parameters of ICF004 in ILD patients.'}, {'measure': 'AUC0-∞ of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients', 'timeFrame': '1 hours, 6 hours, 12 hours, and 24 hours post-dose', 'description': 'AUC0-∞: Area Under the BALF concentration-time Curve from time zero to infinity. Lung pharmacokinetic (PK) parameters of ICF004 in ILD patients.'}, {'measure': 'Tmax of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients', 'timeFrame': '1 hours, 6 hours, 12 hours, and 24 hours post-dose', 'description': 'Tmax: Time to reach maximum BALF concentration. Lung pharmacokinetic (PK) parameters of ICF004 in ILD patients.'}, {'measure': 'Cmax of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients', 'timeFrame': '1 hours, 6 hours, 12 hours, and 24 hours post-dose', 'description': 'Cmax: Peak BALF Concentration. Lung pharmacokinetic (PK) parameters of ICF004 in ILD patients.'}, {'measure': 'T1/2 of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients', 'timeFrame': '1 hours, 6 hours, 12 hours, and 24 hours post-dose', 'description': 'T1/2: Half-life. Lung pharmacokinetic (PK) parameters of ICF004 in ILD patients.'}, {'measure': 'AUC0-24 hours of blood samples in healthy volunteers', 'timeFrame': 'Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose', 'description': 'AUC0-24 hours: Area Under the plasma concentration-time Curve from time zero to 24 hours post-dose. Lung pharmacokinetic (PK) parameters of ICF004 in healthy volunteers'}, {'measure': 'AUC0-∞ of blood samples in healthy volunteers', 'timeFrame': 'Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose', 'description': 'AUC0-∞: Area Under the plasma concentration-time Curve from time zero to infinity. Plasma pharmacokinetic (PK) parameters of ICF004 in healthy volunteers.'}, {'measure': 'Tmax of blood samples in healthy volunteers', 'timeFrame': 'Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose', 'description': 'Tmax: Time to reach maximum plasma concentration. Plasma pharmacokinetic (PK) parameters of ICF004 in healthy volunteers.'}, {'measure': 'Cmax of blood samples in healthy volunteers', 'timeFrame': 'Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose', 'description': 'Cmax: Peak Plasma Concentration. Plasma pharmacokinetic (PK) parameters of ICF004 in healthy volunteers.'}, {'measure': 'T1/2 of blood samples in healthy volunteers', 'timeFrame': 'Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose', 'description': 'T1/2: Half-life. Plasma pharmacokinetic (PK) parameters of ICF004 in healthy volunteers.'}, {'measure': 'Incidence of adverse events and serious adverse events.', 'timeFrame': 'Through study completion, an average of 7 days', 'description': 'Safety Evaluation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Interstitial Lung Disease (ILD)', 'Healthy Volunteers']}, 'descriptionModule': {'briefSummary': "This Phase 1 clinical trial investigates the pharmacokinetics and safety profile of single-dose inhaled ICF004, an epigallocatechin gallate (EGCG) powder formulation, in healthy volunteers and patients with interstitial lung disease (ILD). The randomized, double-blind, dose-escalation study employs a parallel-group design with three inhaled dose cohorts (4mg, 8mg, and 12mg) and one oral comparator arm (600mg Teavigo®), enrolling a total of 42 patients (12 per inhaled group, 6 in oral group) and 42 healthy volunteers (12 per inhaled group, 6 in oral group). The trial features comprehensive pharmacokinetic sampling through 15 timed blood collections over 24 hours and bronchoalveolar lavage at specified intervals (1h, 6h, 12h, or 24h post-dose) to characterize both systemic and pulmonary drug exposure. The study incorporates rigorous safety monitoring including adverse event tracking, vital sign measurements, and laboratory assessments over a 7-day observation period following drug administration. Conducted at Shanghai Jiao Tong University's Ruijin Hospital over a 12-month period (July 2025-July 2026), this investigation aims to establish the foundational pharmacokinetic parameters and safety profile of inhaled EGCG delivery in ILD patients while comparing pulmonary bioavailability against conventional oral administration."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'ICD patients:\n\nInclusion Criteria:\n\n1. Age ≥40 years, any gender\n2. Diagnosed or suspected ILD (IPF or CTD-ILD) based on HRCT or thin-section CT\n3. FVC ≥40% predicted, DLCO ≥40% predicted, FEV1/FVC ≥0.7\n4. Able to tolerate bronchoscopy\n5. Willing to use effective contraception during study\n6. Able to abstain from coffee/tea products 48h before to 48h after dosing\n7. Capable of proper inhaler use\n\nExclusion Criteria:\n\n1. Pregnancy or lactation\n2. Allergy to study drug components\n3. Active respiratory infection or acute cardiopulmonary disease\n4. Abnormal liver function (ALT/AST/GGT \\> ULN or total bilirubin \\> ULN)\n5. Recent smoking (within 6 months) or alcohol abuse\n6. Participation in other clinical trials within 3 months\n7. Blood donation ≥400mL within 3 months\n8. HBV DNA ≥2000 IU/mL or HCV RNA ≥1000 IU/mL or HIV positive'}, 'identificationModule': {'nctId': 'NCT06992661', 'briefTitle': 'A Study of the Pharmacokinetics and Safety of Single-dose Inhaled ICF004 in Healthy Volunteers and Patients With Interstitial Lung Disease', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'A Study of the Pharmacokinetics and Safety of Single-dose Inhaled ICF004 in Healthy Volunteers and Patients With Interstitial Lung Disease', 'orgStudyIdInfo': {'id': '20250508'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental 1-ICD', 'description': 'ICF004 inhaled powder, 4 mg, inhalation', 'interventionNames': ['Drug: ICF004 inhaled powder']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental 2-ICD', 'description': 'ICF004 inhaled powder, 8 mg, inhalation', 'interventionNames': ['Drug: ICF004 inhaled powder']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental 3-ICD', 'description': 'ICF004 inhaled powder, 12 mg, inhalation', 'interventionNames': ['Drug: ICF004 inhaled powder']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator-ICD', 'description': 'Teavigo®, 600mg, Oral', 'interventionNames': ['Drug: Oral Teavigo® capsules']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental 1-Healthy volunteer', 'description': 'ICF004 inhaled powder, 4 mg, inhalation', 'interventionNames': ['Drug: ICF004 inhaled powder']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental 2-Healthy volunteer', 'description': 'ICF004 inhaled powder, 8 mg, inhalation', 'interventionNames': ['Drug: ICF004 inhaled powder']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental 3-Healthy volunteer', 'description': 'ICF004 inhaled powder, 12 mg, inhalation', 'interventionNames': ['Drug: ICF004 inhaled powder']}, {'type': 'EXPERIMENTAL', 'label': 'Active Comparator-Healthy volunteer', 'description': 'Teavigo®, 600mg, Oral', 'interventionNames': ['Drug: Oral Teavigo® capsules']}], 'interventions': [{'name': 'ICF004 inhaled powder', 'type': 'DRUG', 'description': 'ICF004 is an investigational inhaled powder formulation containing epigallocatechin gallate (EGCG), the most biologically active polyphenol component derived from green tea extract. Developed for targeted pulmonary delivery, ICF004 utilizes a proprietary RS01 dry powder inhaler device to achieve localized therapeutic effects in lung tissue while minimizing systemic exposure.\n\nThe formulation consists of micronized EGCG (≥90% purity) in precisely dosed capsules (1mg or 4mg per unit). Preclinical studies demonstrate that inhaled administration achieves 10-20× higher lung concentrations compared to oral dosing, with correspondingly lower plasma levels - potentially reducing the hepatotoxicity risk associated with high oral EGCG doses (European Food Safety Authority recommends \\<800mg/day orally).', 'armGroupLabels': ['Experimental 1-Healthy volunteer', 'Experimental 1-ICD', 'Experimental 2-Healthy volunteer', 'Experimental 2-ICD', 'Experimental 3-Healthy volunteer', 'Experimental 3-ICD']}, {'name': 'Oral Teavigo® capsules', 'type': 'DRUG', 'description': 'Teavigo® is a standardized, high-purity epigallocatechin gallate (EGCG) supplement developed by DSM Nutritional Products. The oral capsules contain ≥94% pure EGCG extracted from green tea (Camellia sinensis), making them one of the most concentrated commercially available EGCG formulations.', 'armGroupLabels': ['Active Comparator-Healthy volunteer', 'Active Comparator-ICD']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jieming QU', 'investigatorAffiliation': 'Ruijin Hospital'}}}}