[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"viral-respiratory-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:viral-respiratory-infection":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100610060","phase-2-a-study-assessing-safety-tolerability-and-efficacy-of-inna-051-in-preventing-respiratory-illness-due-to-viral-infections-in-healthy-adults-18-to-45-years-of-age-100610060",false,"NCT07222670","A Study Assessing Safety, Tolerability, and Efficacy of INNA-051 in Preventing Respiratory Illness Due to Viral Infections in Healthy Adults 18 to 45 Years of Age","A Randomized, Double-Blind, Two-Part, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate Safety, Tolerability, and Efficacy of INNA-051 as Prophylaxis for Respiratory Tract Illness in Healthy Adults 18 to 45 Years of Age Who Are at Risk for Viral Respiratory Infections","POSITS","Inclusion Criteria:\n\n* In good general health and without clinically significant medical, psychiatric, chronic or intermittent health conditions.\n* At risk for exposure to viral respiratory infection, for example, living in crowded housing, university housing, or military barracks, working in a childcare center or caring for a child aged 10 or less, healthcare workers, factory workers, taxi and bus drivers, grocery clerks, and educators or counselors who work in crowded environments or with multiple exposures with different people daily.\n* Agree to use highly effective birth control.\n\nExclusion Criteria:\n\n* Presence of Type I or Type II diabetes, asthma or other chronic respiratory condition.\n* Active infections including Hepatitis B Virus, Hepatitis C Virus, or Human Immunodeficiency (HIV).\n* Concurrent participation in another clinical trial involving investigational product or prior receipt of investigational product within 90 days or 5 half-lives of the product.\n* Active clinical signs or symptoms of acute respiratory illness (runny nose, sore throat, fever, etc.).\n* Received a vaccine against Respiratory Syncytial Virus (RSV) or COVID-19 within 180 days.\n* Pregnant or lactating women.",true,"ALL","18 Years","45 Years",{"count":22,"type":23},1100,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","Acute upper and lower respiratory infections are a major public health problem and a leading cause of morbidity and mortality worldwide. The purpose of this trial is to assess the safety of the investigational agent INNA-051, given intranasally, and its potential effectiveness in reducing the occurrence, severity, and\u002For the duration of illness resulting from respiratory virus infections. The trial will enroll generally healthy adults (age 18 - 45 years) who are at risk for exposure to viral respiratory infection, for example, due to living conditions or occupation. Participants will be treated with INNA-051 or placebo once weekly for 4 weeks (Part A) or 12 weeks (Part B) during the respiratory virus season.",[29,30],"Viral Respiratory Infection","Viral Respiratory Illnesses",[32,33,34,35,36,37],"Respiratory virus","Viral respiratory infection","Viral respiratory illness","Prophylaxis","Intranasal","Viral respiratory disease","RECRUITING","2026-02-09",{"date":41,"type":42},"2026-02-11","ACTUAL",{"date":44,"type":42},"2025-12-04",{"date":46,"type":23},"2027-02-09",{"name":48,"class":49},"ENA Respiratory Pty Ltd","INDUSTRY",5,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":58,"targetDuration":4,"studyType":24,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100582132","phase-1-study-of-the-safety-tolerability-and-pharmacokinetic-profile-of-ascending-doses-of-ingavirin-forte-capsules-folliwing-single-and-subsequent-multiple-oral-administration-in-healthy-volunteers-100582132","NCT06859333","Study of the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of Ingavirin Forte, Capsules, Folliwing Single and Subsequent Multiple Oral Administration in Healthy Volunteers","An Open-label Study of the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of Ingavirin Forte, Capsules, Folliwing Single and Subsequent Multiple Oral Administration in Healthy Volunteers","Inclusion Criteria:\n\n1. Signed informed consent form by the healthy subject prior to any study activities.\n2. Males and females aged 18 to 45 years (inclusive) of Caucasian race.\n3. Verified \"healthy\" diagnosis (no abnormalities detected based on clinical, laboratory, and instrumental examination methods specified in the protocol).\n4. Blood pressure (BP) levels: systolic blood pressure (SBP) from 100 to 130 mm Hg (inclusive), diastolic blood pressure (DBP) from 70 to 85 mm Hg (inclusive).\n5. Heart rate (HR) from 60 to 89 beats per minute (inclusive).\n6. Respiratory rate (RR) from 12 to 20 breaths per minute (inclusive).\n7. Body temperature from 36.0°C to 36.9°C (inclusive).\n8. Body mass index (BMI): 18.5 kg\u002Fm² ≤ BMI ≤ 30 kg\u002Fm², with a minimum body weight of ≥ 55 kg for men and ≥ 45 kg for women.\n9. Agreement to use adequate contraceptive methods throughout the study and for 30 days after its completion; for women of childbearing potential - a negative urine pregnancy test result.\n\nNon-inclusion criteria:\n\n1. Known allergic history.\n2. Hypersensitivity to imidazolylethylamide of pentanedioic acid and N,N'-bis-\\[2-(1,3-diazocyclopent-2,4-dien-4-yl)ethyl\\] diamide of malonic acid (XC9) and\u002For excipients included in the study drug in the medical history.\n3. Drug intolerance to imidazolylethylamide of pentanedioic acid and N,N'-bis-\\[2-(1,3-diazocyclopent-2,4-dien-4-yl)ethyl\\] diamide of malonic acid (XC9) and\u002For excipients included in the study drug.\n4. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.\n5. Evidence or history of chronic diseases of the kidneys, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital, and immune systems, as well as skin, hematopoietic and vision organs.\n6. History of GIT surgery (except for appendectomy at least 1 year prior to screening).\n7. Diseases\u002Fconditions that, in the judgment of the investigator, may affect the absorption, distribution, metabolism, or excretion of the study drug (SD).\n8. Acute infectious diseases less than 4 weeks before screening.\n9. Use of drugs that significantly affect hemodynamics, drugs affecting liver function (barbiturates, omeprazole, cimetidine, etc.), drugs that prolong the QT interval (antipsychotics (haloperidol, quetiapine, olanzapine, risperidone, sulpiride), antidepressants (fluoxetine, sertraline), antiarrhythmics (amiodarone), antibiotics (clarithromycin, azithromycin, moxifloxacin, levofloxacin, ciprofloxacin), antifungals (fluconazole), diuretics (furosemide)), less than 2 months before screening.\n10. Regular use of drugs less than 2 weeks before screening and single use of drugs less than 7 days before screening (including over-the-counter drugs, vitamins, dietary supplements, herbal medicines).\n11. Blood or plasma donation within 3 months before screening.\n12. Use of hormonal contraceptives (in women) within 2 months before the start of screening.\n13. Use of depot injections of any drugs less than 3 months before the start of screening.\n14. Pregnancy or lactation; positive urine pregnancy test for women of childbearing potential.\n15. Women of childbearing potential who have had unprotected sexual intercourse within 30 days prior to taking study medications with an unsterilized partner.\n16. Participation in another clinical trial less than 3 months prior to screening or concurrently with this study.\n17. Consumption of more than 10 units of alcohol per week in the last month before inclusion in the study or a history of alcoholism, drug addiction, or substance abuse.\n18. Smoking more than 10 cigarettes per day currently or having smoked that amount in the past 6 months prior to screening; unwillingness to refrain from smoking during their stay at the research center.\n19. Consumption of alcohol, caffeine, and xanthine-containing products within 7 days prior to taking the study drug.\n20. Consumption of citrus fruits, cranberries, rose hips and products containing them, preparations or products containing St. John's wort within 7 days prior to taking the study drug.\n21. Dehydration due to diarrhea, vomiting or other causes within the last 24 hours before taking the study drug.\n22. Positive blood test to human immunodeficiency virus (HIV) types 1 and 2; antibodies to Treponema pallidum antigens; surface antigen of hepatitis B virus (HBsAg); antibodies to hepatitis C virus antigens at screening.\n23. Clinically significant deviations on electrocardiogram (ECG) in medical history and\u002For at screening including: QTcF interval (corrected by Fredericia) ≥430 ms in men and ≥450 ms in women.\n24. Information on risk factors for developing torsades de pointes such as heart failure, hypokalemia, family history of prolonged QT syndrome.\n25. Positive urine test for narcotic substances and potent medications at screening.\n26. Positive test for alcohol vapors at screening.\n27. Planning hospitalization during the study period for any reason other than hospitalization provided for by this protocol.\n28. Inability or unwillingness to comply with protocol requirements, perform procedures prescribed by the protocol, adhere to dietary and activity regimens.\n29. Belonging to a vulnerable group of volunteers: students from higher and secondary medical, pharmaceutical and dental educational institutions; junior staff from clinics and laboratories; employees of pharmaceutical companies; military personnel and prisoners; individuals in nursing homes; low-income and unemployed individuals; representatives of national minorities; homeless individuals; refugees; individuals under guardianship or custody; individuals unable to give consent; as well as law enforcement officers.\n30. Other conditions that, in the judgment of the investigator, may interfere with participation in the study or may lead to early withdrawal of the volunteer including adherence to fasting or special diets (e.g., vegetarianism, veganism, salt restriction) or a special lifestyle (night work hours, extreme physical exertion).\n\nExclusion Criteria:\n\n1. The volunteer's withdrawal from further participation in the study.\n2. Non-compliance by the volunteer with the study participation rules (missed study procedures, self-administration of prohibited medications, violation of dietary and lifestyle restrictions, etc.).\n3. The emergence of reasons\u002Fsituations during the study that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.).\n4. Volunteers selected for participation in the study who do not meet inclusion\u002Fexclusion criteria.\n5. Development of a severe adverse event (SAE) and\u002For serious adverse reaction (SAR) in the volunteer during the study.\n6. The volunteer requires or undergoes treatment that may affect the pharmacokinetics of the study drug.\n7. Missing two or more consecutive blood samples or three or more blood samples during one study period.\n8. The occurrence of vomiting\u002Fdiarrhea within 8 hours after taking the study drug.\n9. Positive urine test for narcotic substances and potent medications.\n10. Positive test for alcohol vapors.\n11. Positive pregnancy test in female participants.\n12. The emergence of other reasons during the study that prevent the conduct of the study according to the protocol.",{"count":59,"type":23},36,[61],"PHASE1","This is a Single Center, First-in-human Study of Safety, Tolerability, and Pharmacokinetic Profile of Ascending Single and Multiple Doses of Ingavirin Forte, Capsules in Healthy Volunteers.",[64,29],"Influenza","2025-07-02",{"date":67,"type":42},"2025-07-08",{"date":69,"type":42},"2025-01-13",{"date":71,"type":23},"2025-12-31",{"name":73,"class":49},"Valenta Pharm JSC",1]