[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lumen Bioscience, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"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":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100658427","phase-1-a-study-of-intranasal-lmn-1001-in-healthy-adults-100658427",false,"NCT07852208","A Study of Intranasal LMN-1001 in Healthy Adults","Trial to Optimize Tolerability and Explore the Pharmacodynamics of Intranasal LMN-1001","Inclusion Criteria:\n\n* Male and female adults aged \\> 18 and \\\u003C 65 years at screening\n* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg\u002Fm2, with a maximum body weight of 120 kg at screening\n* General good health, without significant medical illness or abnormal physical examination, or laboratory findings per PI discretion\n* Willing and able to comply with all study activities, assessments, and restrictions through 28 days of follow-up, have provided written informed consent to participate in the clinical trial before any study-related activities are carried out, and, in the PI's opinion, able to understand the full nature and purpose of the trial, including possible risks and adverse effects\n* Subjects of child-bearing potential use effective contraception from screening through 12 weeks after study dosing.\n\n  * Female volunteers must:\n\n    * Be of nonchildbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause, and a follicle-stimulating hormone level \\>40 IU\u002FL at the screening visit), or\n    * If of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use an acceptable method of contraception from signing the consent form until at least 30 days after the last dose of the study drug.\n  * Male volunteers must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception from signing the consent form until at least 90 days after the last dose of study drug\n\nExclusion Criteria:\n\n* History or presence of clinically significant medical condition or disease, including (but not limited to) clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease\n* Any acute illness or surgery within the past 12 weeks prior to screening determined by the PI to be clinically relevant\n* Known allergy or previous anaphylaxis to any components of the study product\n* Allergies, a history of allergic conditions, nasal or sinus conditions, upper respiratory conditions, or chronic respiratory conditions, including seasonal allergies and mild asthma (history of childhood asthma or childhood allergies are not exclusionary)\n* History of nasal or upper respiratory pathology or abnormalities\n* Ongoing (within 28 days of study product administration through end of follow-up) use of nasal spray or drops and\u002For use of any intranasal spray or drops and\u002For inhaled product within 28 days prior to study drug administration.'\n* Ongoing (within 28 days of study product administration through end of follow-up) or planned treatment with immunomodulator or immunosuppressant agents or medicines (including over the counter, herbal and prescription drugs and supplements with significant activity in the respiratory tract)\n* Treatment with an investigational device or compound within 30 days or 5 half-lives (whichever is longer) prior to study product administration\n* Current or planned pregnancy or breastfeeding\u002Flactating\n* Tobacco or nicotine use from screening through 28 days of study product administration\n* Unable or unwilling to provide adequate informed consent",true,"ALL","18 Years","65 Years",{"count":21,"type":22},36,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of this study is to optimize the tolerability of LMN-1001 relative to its ability to activate the host immune response. LMN-1001 is an investigational dry powder containing recombinant interferon lambda (IFN-λ).\n\nResearchers will monitor side effects, vital signs, nasal symptoms, physical examination findings, and laboratory test results. Nasal and blood samples will be collected to determine how long LMN-1001 remains in the nose, whether it reaches the bloodstream, whether the body produces antibodies against it, and whether it causes local or whole-body immune responses. Participants will be followed through Day 28.",[28],"Viral Infections",[30,31,32,33,34,35,36,37,38,39],"LMN-1001","Interferon Lambda","Innate Immunity","Host-Directed Antiviral","Intranasal","Safety","Tolerability","Nasal Mucosa","Immunity","Spirulina","NOT_YET_RECRUITING","2026-09-25",{"date":43,"type":44},"2026-10-01","ACTUAL",{"date":46,"type":22},"2026-11-09",{"date":48,"type":22},"2027-07-24",{"name":50,"class":51},"Lumen Bioscience, Inc.","INDUSTRY",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":16,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":52},"100558885","early-phase-1-gi-pharmacokinetics-of-lmn-401-in-individuals-with-ileostomies-100558885","NCT06556940","G.I. Pharmacokinetics of LMN-401 in Individuals With Ileostomies","A Clinical Trial to Assess the Intraluminal Pharmacokinetics of LMN-401 in Individuals With Ileostomies","Inclusion Criteria:\n\n* Aged 19 years and above\n* Medically stable\n* Mature and stable ileostomy (no revisions in past 6 months)\n* Willing and able to participate in all study visits\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Unable or unwilling to provide adequate informed consent\n* Gastroparesis\n* Using or planning to use anti-diarrheal medication\n* Using or planning to use opioids\n* Clinically significant disease\n* Women who are pregnant, intending to become pregnant, or breastfeeding\n* Non-English speakers","19 Years",{"count":62,"type":22},12,[64],"EARLY_PHASE1","The goal of this interventional study is to learn about the intraluminal pharmacokinetics (PK) of the investigational drug LMN-401 in adult healthy volunteers with ileostomies. LMN-401 is being developed as a potential new treatment for Traveler's Diarrhea. The study will also learn about the safety of the investigational drug LMN-401.\n\nThe main questions it aims to answer are:\n\n* What is the timing and amount of components of investigational drug LMN-401 detected in the collected ileostomy material?\n* Is LMN-401 safe and well tolerated in healthy volunteers taking the investigational drug?\n\nResearchers will compare the timing and amount of investigational drug components detected in the ileostomy material in volunteers taking the investigational drug LMN-401 formulated into tablets with different properties. The impact of the study participant's fed or fasted state on the timing and amount of drug components detected in the ileostomy material will also be evaluated.\n\nEach study participant will come into the research clinic for four study visits. Study participants will receive the investigational product formulated into tablets with different properties. Ileostomy material will be collected at baseline (pre-dose) and every two hours after investigational product dose administration for 10 hours.",[67],"Travelers Diarrhea","RECRUITING","2025-01-07",{"date":71,"type":44},"2025-01-09",{"date":73,"type":44},"2024-12-04",{"date":75,"type":22},"2025-12-02",{"name":50,"class":51},""]