[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nanjing Reju Therapeutics Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100633593","phase-1-a-clinical-study-to-evaluate-the-safety-tolerability-and-pharmacokinetic-characteristics-of-rc010-inhalation-powder-in-healthy-participants-100633593",false,"NCT07528703","A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of RC010 Inhalation Powder in Healthy Participants","A Phase Ia Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of RC010 Inhalation Powder in Healthy Chinese Participants","Inclusion Criteria:\n\n1. Be able to communicate well with the researchers, fully understand the objectives and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form;\n2. Aged between 18 and 55 years inclusive, of both genders;\n3. Have a body mass index (BMI) between 19.0 kg\u002Fm² and 28.0 kg\u002Fm² inclusive, and a body weight of ≥ 50.0 kg for males or ≥ 45.0 kg for females;\n4. Have no plans for childbearing, sperm donation or egg donation from the time of voluntarily signing the informed consent form until 90 days after the last dose, and voluntarily adopt medically approved contraceptive measures (including their partners, see Appendix 1 for details).\n\nExclusion Criteria:\n\n1. Received clinical trial medication or participated in other medical research activities within 3 months prior to screening, and is deemed unsuitable for study enrollment by the investigator.\n2. Has a history of or currently suffers from clinically unstable diseases\u002Fabnormalities of the cardiovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatological, infectious, hematological, nervous, or neuropsychiatric systems, which the investigator judges to interfere with study conduct.\n3. Has a history of glaucoma, functional constipation, benign prostatic hyperplasia, urinary tract obstruction, or similar conditions.\n4. Has a history of severe oral\u002Fmaxillofacial deformities, or presents with oral candidiasis, ulcers, or other mucosal lesions at screening that may affect oral inhalation administration.\n5. Has a past or current history of bleeding risk-increasing diseases (e.g., acute gastritis, active bleeding peptic ulcers), clinically significant thrombocytopenia\u002Fanemia (Hb \\\u003C 80 g\u002FL and\u002For PLT \\\u003C 100×10⁹\u002FL), active pathological bleeding, or intracranial hemorrhage history.\n6. Suffered from lower respiratory tract infection, or upper respiratory tract infection requiring antibiotic therapy, within 6 weeks prior to screening\u002Fenrollment.\n7. Has a history of chronic obstructive pulmonary disease (COPD) or other respiratory diseases, including but not limited to tuberculosis infection, α-1 antitrypsin deficiency, cystic fibrosis, symptomatic asthma, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary arterial hypertension, pulmonary edema, or interstitial lung disease.\n8. Received any live vaccine (excluding influenza vaccine) within 30 days prior to screening, or plans to receive vaccines during the study period.\n9. Has a history of drug allergies, specific allergic conditions (e.g., asthma, urticaria, eczema), is an atopic individual (allergic to ≥2 types of drugs\u002Ffoods\u002Fpollen), or has a known allergy to any component of RC010 Inhalation Powder.\n10. Lost blood or donated blood \\> 400 mL within 3 months prior to screening (excluding female menstrual blood loss), or intends to donate blood during the study or within 1 month post-study.\n11. Underwent surgery within 1 month prior to screening, or plans to undergo surgery during the study period.\n12. Excessively consumed tea, coffee, or caffeinated beverages (average ≥ 8 cups\u002Fday, 250 mL\u002Fcup) within 6 months prior to screening.\n13. Ingested caffeine\u002Fxanthine-containing products (e.g., coffee, tea, cola, chocolate), poppy seed-containing foods, or CYP2C8\u002FCYP3A4-affecting substances (e.g., limes, grapefruit\u002Fjuice, pomelos) within 48 hours prior to investigational product administration.\n14. Used hepatic drug-metabolizing enzyme inhibitors\u002Finducers within 28 days prior to screening; or used prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health supplements within 14 days prior to screening. For long half-life drugs, the washout period shall be at least 5 times the drug half-life.\n15. Has special dietary requirements and cannot comply with the unified study diet.\n16. Has venous blood collection difficulties, or a history of needle phobia\u002Fhematophobia.\n17. Is a heavy smoker (smoking ≥ 5 cigarettes\u002Fday within 3 months prior to the first dose), cannot comply with smoking prohibition during the study, or has a positive smoking test result.\n18. Has a history of regular alcohol consumption within 6 months prior to screening (women \\> 14 standard units\u002Fweek, men \\> 21 standard units\u002Fweek; 1 unit = 14g alcohol), cannot abstain from alcohol during the study, or has a positive breath alcohol test result.\n19. Has a history of drug abuse, or has a positive drug abuse screening result (including benzodiazepines, methamphetamine, cocaine, morphine, ketamine, tetrahydrocannabinol carboxylic acid).\n20. Has clinically significant abnormal findings in screening physical examination, vital signs, laboratory tests (blood\u002Furine\u002Fstool routine, biochemistry, coagulation, thyroid function, etc.), abdominal B-ultrasound, or chest X-ray, as judged by the investigator.\n21. Has positive screening results for HBsAg, anti-HCV, TPPA, or HIV-Ag\u002FAb.\n22. Has screening pulmonary function test results showing FEV₁\u002Fpredicted value ≤ 80%, FVC ≤ 80% of predicted value, or other clinically significant abnormalities.\n23. Is a pregnant\u002Flactating woman, or has a positive screening blood pregnancy test result.\n24. Has clinically significant abnormal 12-lead ECG findings at screening (e.g., bradycardia\u002Ftachycardia, QTcF ≥ 450 ms \\[male\\]\u002F≥ 470 ms \\[female\\], arrhythmia), as judged by the investigator.\n25. Has screening serum potassium concentration \\\u003C 3.5 mmol\u002FL.\n26. Is unwilling\u002Funable to correctly use the inhaler for investigational product administration, or fails inhalation training.\n27. Is deemed unsuitable for study participation due to other circumstances judged by the investigator.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},42,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Phase 1A, first in human, randomized, double-blinded, placebo-controlled, dose escalation study of RC010 in healthy adult volunteers. RC010 is a small-molecule drug , being developed as a novel therapeutic treatment for patients with Idiopathic Pulmonary fibrosis (IPF). This study aims to evaluate the safety, tolerability and pharmacokinetics of RC010 after Single ascending doses .",[28],"IPF","NOT_YET_RECRUITING","2026-04-07",{"date":32,"type":33},"2026-04-14","ACTUAL",{"date":35,"type":22},"2026-04",{"date":37,"type":22},"2027-12",{"name":39,"class":40},"Nanjing Reju Therapeutics Co., Ltd","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":58,"leadSponsor":60,"locationsCount":4},"100633058","phase-1-a-study-to-evaluate-the-safety-tolerability-and-pharmacokinetic-profile-of-rc017-ophthalmic-ointment-following-single-and-multiple-doses-in-healthy-adult-participants-100633058","NCT07521748","A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of RC017 Ophthalmic Ointment Following Single and Multiple Doses in Healthy Adult Participants","A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of RC017 Ophthalmic Ointment Following Single and Multiple Doses in Healthy Adult Participants","Inclusion Criteria:\n\n1. Healthy male and female trial participants aged 18 to 55 years old (inclusive);\n2. Body Mass Index (BMI) ranging from 19.0 to 26.0 kg\u002Fm² (inclusive), with body weight ≥ 50 kg for males and ≥ 45 kg for females;\n3. At screening, best corrected visual acuity (BCVA) of both eyes should be ≥ 1.0; in addition, ophthalmic examinations (including assessment of ocular symptoms, slit-lamp microscopy\u002Fexternal eye examination, corneal fluorescein staining, funduscopy, and intraocular pressure measurement) should show no abnormalities in both eyes, or any abnormalities detected should be judged as clinically insignificant by the investigator;\n4. Have a full understanding of the trial procedures, voluntarily participate in the trial, and sign a written informed consent form (ICF);\n5. Female participants with childbearing potential must have a negative result in the serum pregnancy test at screening. Throughout the entire study period and within 3 months after the study conclusion, all female participants, male participants and their sexual partners must agree to adopt effective contraceptive measures (Note: Contraceptive measures include both pharmacological and non-pharmacological methods, see Appendix 4 for details).\n\nExclusion Criteria:\n\n1. History of ocular diseases deemed by the investigator as unsuitable for enrollment, including but not limited to dry eye, glaucoma, blepharitis, meibomianitis, allergic conjunctivitis, iritis, uveitis, and\u002For active ocular inflammation or infection.\n2. Prior history of ocular surgeries, including laser refractive surgery and intraocular surgery, etc.\n3. Participants who wore contact lenses or cosmetic colored contact lenses within 2 weeks prior to screening, or those requiring contact lens wear during the trial.\n4. Use of any prescription or over-the-counter (OTC) medications (including vitamins, antacids, Chinese herbal medicines, dietary supplements, and topical ophthalmic drugs) within 2 weeks prior to screening.\n5. Clinically significant abnormalities in vital signs, physical examination findings, laboratory test results (complete blood count \\[CBC\\], urine routine, blood biochemistry, coagulation function, infectious disease screening, serum pregnancy test \\[females only\\]) or 12-lead electrocardiogram (ECG), as judged by the investigator.\n6. History of diseases involving the central nervous, mental, cardiovascular, renal, hepatic, respiratory, metabolic, or musculoskeletal systems, which in the investigator's judgment may compromise participant safety or interfere with study results.\n7. Clinically significant history of allergies, especially drug allergies, or known hypersensitivity to any component of the study drug.\n8. Daily cigarette smoking \\> 5 sticks within 3 months prior to the trial.\n9. Suspected or confirmed alcohol dependence; average daily alcohol intake \\> 2 units within 3 months (1 unit = 10 mL pure ethanol, equivalent to 200 mL beer \\[5% alcohol\\], 25 mL spirits \\[40% alcohol\\], or 83 mL wine \\[12% alcohol\\]); or positive alcohol test result.\n10. History of drug abuse; or positive urine test for ketamine, morphine, methamphetamine, MDMA, or tetrahydrocannabinol carboxylic acid (THC-COOH).\n11. Participation in another clinical trial within 3 months prior to screening.\n12. Blood donation or blood loss ≥ 400 mL within 3 months prior to screening.\n13. Pregnant or lactating females.\n14. Unsuitability for venous blood collection.\n15. Vaccination within 30 days prior to screening, or planned vaccination during the study period.\n16. Any other conditions deemed by the investigator as unsuitable for enrollment.",{"count":50,"type":22},24,[25],"This is a Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of RC017 Ophthalmic Ointment Following Single and Multiple Doses in Healthy Adult Participants.RC017 is a small-molecule drug, being developed as a novel therapeutic treatment for patients with Dry Eye Disease (DED) . This study aims to evaluate the safety, tolerability and pharmacokinetics of RC017 after Single and Multiple Doses.",[54],"Dry Eye",{"date":56,"type":33},"2026-04-13",{"date":35,"type":22},{"date":59,"type":22},"2027-04",{"name":39,"class":40},""]