[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648299":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":11,"centralContacts":43,"locations":11,"responsibleParty":49,"collaborators":11,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":11,"overallStatus":75,"whyStopped":11,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":11},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,14,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 (SAD): ICF004","EXPERIMENTAL",null,[13],"Drug: ICF004",{"label":15,"type":16,"description":11,"interventionNames":17},"Part 1 (SAD): Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",{"label":20,"type":10,"description":11,"interventionNames":21},"Part 2 (MAD): ICF004",[13],{"label":23,"type":16,"description":11,"interventionNames":24},"Part 2 (MAD): Placebo",[25],"Drug: Pacebo",[27,32,36,39],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"DRUG","ICF004","Participants in the Single Ascending Dose (SAD) part will receive a single dose of ICF004 via dry powder inhaler. There are 5 planned dose cohorts (1, 4, 8, 12, and 16 mg).",[9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"Placebo","Participants in the Single Ascending Dose (SAD) part will receive a single dose of matching placebo via dry powder inhaler.",[15],{"type":28,"name":29,"description":37,"armGroupLabels":38,"otherNames":11},"Participants in the Multiple Ascending Dose (MAD) part will receive multiple doses of ICF004 via dry powder inhaler. The doses will be administered once daily (QD) or twice daily (BID). There are 4 planned cohorts. The exact dose levels will be determined based on the safety and tolerability results from Part 1.",[20],{"type":28,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"Pacebo","Participants in the Multiple Ascending Dose (MAD) part will receive multiple doses of matching placebo via dry powder inhaler, administered once daily (QD) or twice daily (BID).",[23],[44],{"name":45,"role":46,"phone":47,"phoneExt":11,"email":48},"Jingya Zhao, Ph.D","CONTACT","86-21-64370045","jingya2010@126.com",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Jieming QU","Professor","100648299","phase-1-the-safety-and-pk-study-of-inhaled-icf004-in-healthy-chinese-volunteers-100648299",false,"NCT07719218","The Safety and PK Study of Inhaled ICF004 in Healthy Chinese Volunteers","A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Inhaled Doses of ICF004 in Healthy Chinese Participants","ICF004-INH","Inclusion Criteria:\n\n1. Fully understand the study procedures and methods, volunteer to participate in this study, and sign the written informed consent form.\n2. Healthy adult participants, male or female, aged 18 to 50 years (inclusive).\n3. Body Mass Index (BMI) ≥ 18 and \\\u003C 28 kg\u002Fm²; body weight ≥ 50.0 kg and \\\u003C 90.0 kg for males, and ≥ 45.0 kg and \\\u003C 90.0 kg for females.\n4. Medically healthy as determined by the investigator, based on the absence of clinically significant abnormalities in physical examinations, laboratory tests, vital signs, chest X-ray, and electrocardiogram (ECG).\n5. Able to use the inhalation device correctly and effectively.\n6. Agree to use effective contraceptive measures throughout the study period. Female participants of childbearing potential must agree to use effective contraception from the screening period until 6 months after the last dose. During this period, female participants must agree to have no plans for pregnancy or egg donation\u002Fharvesting; male participants must agree to have no plans to father a child or donate sperm. Their male or female partners of childbearing potential must also agree to use effective contraceptive measures during this period.\n\nExclusion Criteria:\n\n1. History of any clinically significant disease (including past and current history), including but not limited to respiratory, cardiovascular, gastrointestinal, hematological, endocrine, immunological, dermatological, malignant tumor, neuropsychiatric, ear\u002Fnose\u002Fthroat (ENT), or metabolic diseases; or any other condition that, in the opinion of the investigator (or sub-investigator), makes the participant unsuitable for the study.\n2. Major surgery within 6 months prior to dosing, planned surgery during the study, or previous surgery that may significantly affect the pharmacokinetics or safety evaluation of the study drug.\n3. Current oral diseases that may affect the study, as judged by the investigator (e.g., oropharyngeal candidiasis, oral ulcers, oral mucosal lesions).\n4. Fever (body temperature \\> 37.5°C) or symptomatic respiratory infection within 1 month prior to dosing; any infection requiring systemic antibiotics or antivirals within 3 months prior to screening; or a history of recurrent infections.\n5. Positive test results for Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen (HBsAg), Treponema pallidum (syphilis) antibody, or Hepatitis C Virus (HCV) antibody.\n6. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), or total bilirubin exceeding the upper limit of normal (ULN) at the screening or baseline visit.\n7. Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) \\\u003C 80% of the predicted value, or FEV1\u002FFVC \\\u003C 0.7, or arterial oxygen saturation \\\u003C 95% at the screening or baseline visit.\n8. Smoking (including e-cigarettes) within 6 months prior to dosing, or a positive smoking (nicotine\u002Fcotinine) test.\n9. History of drug abuse within 3 months prior to screening, or a positive urine drug screen.\n10. Participation in any drug or medical device clinical trial within 3 months prior to screening.\n11. Blood donation or blood loss ≥ 400 mL within 3 months prior to dosing.\n12. Difficulty in venous blood sampling, intolerance to venipuncture, or a history of needle or blood phobia (vasovagal syncope).\n13. Known allergy to the study drug or any of its ingredients.\n14. Female participants who are pregnant or lactating, or who plan to become pregnant from the time of the study through 6 months after the last dose.\n15. Any condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.",true,"ALL","18 Years","50 Years",{"count":66,"type":67},73,"ESTIMATED","INTERVENTIONAL",[70],"PHASE1","The goal of this clinical trial is to learn about the safety of an inhaled study drug called ICF004 in healthy adults. ICF004 is being created to treat progressive lung scarring in the future. It will also learn how the body handles the drug over time.\n\nThe main questions it aims to answer are:\n\nWhat medical problems or side effects do participants have when taking ICF004? How does the body absorb and metabolize ICF004? Researchers will compare ICF004 to a placebo (a look-alike powder that contains no active drug) to see if ICF004 is safe and well-tolerated.\n\nParticipants will:\n\nBreathe in a single dose or multiple doses of ICF004 or a placebo using a dry powder inhaler; Stay at or visit the study clinic for checkups and tests; Give blood samples so researchers can measure the amount of drug in their blood.",[73,74],"Interstitial Lung Disease (ILD)","Healthy Volunteers","NOT_YET_RECRUITING","2026-07-17",{"date":78,"type":79},"2026-07-22","ACTUAL",{"date":81,"type":67},"2026-07-30",{"date":83,"type":67},"2029-07-30",{"name":5,"class":6}]