[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557040":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":39,"locations":47,"responsibleParty":71,"collaborators":31,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":31,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":31,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":31,"overallStatus":50,"whyStopped":31,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Mannkind Corporation","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"(Part A) MKND-201 SAD","EXPERIMENTAL","Part A involves a Single Ascending Dose (SAD) study with three cohorts. In each cohort, participants will receive a single dose of MKND-201 or placebo for one day. The doses will be categorized as Target Dose, High Dose, and Very High Dose. Allocation is randomized and double-blind, maintaining a ratio of 3:1 (MKND-201:placebo). Participants will use a breath-powered inhaler, which aerosolizes the powder for lung delivery",[13],"Drug: (Part A) MKND-201",{"label":15,"type":10,"description":16,"interventionNames":17},"(Part B) MKND-201 MAD","Part B involves a Multiple Ascending Dose (MAD) study with two cohorts. In each cohort, participants will receive MKND-201 or placebo twice daily (BID) at either the Target Dose or High Dose. Allocation is randomized 3:1 (MKND-201:placebo) and double-blind. Participants will use a breath-powered inhaler, which aerosolizes the powder for lung delivery",[18],"Drug: (Part B) MKND-201",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","Administered as a single dose or BID using the same number of cartridges as MKND-201 participants in the same cohort",[24],"Drug: Placebo",[26,32,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","(Part A) MKND-201","Participants will receive single ascending doses (Target Dose, High Dose, and Very High Dose) of MKND-201 or placebo administered via oral inhalation on Day 1",[9],null,{"type":27,"name":20,"description":33,"armGroupLabels":34,"otherNames":31},"Participants will receive matching placebo across Part A and Part B of the study.",[20],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":31},"(Part B) MKND-201","Participants will receive multiple ascending doses (Target Dose and High Dose) of MKND-201 or placebo administered via oral inhalation, twice daily, from Day 1 to Day 7",[15],[40,45],{"name":41,"role":42,"phone":43,"phoneExt":31,"email":44},"Jennifer Pleitez","CONTACT","818-661-5000","MKC-NI-001study@mannkindcorp.com",{"name":46,"role":42,"phone":43,"phoneExt":31,"email":44},"Johanna Ulloa",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Flourish Research","RECRUITING","San Antonio","Texas","78229","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-98.49363,29.42412,{"lat":60,"lon":59},[63,68],{"name":64,"role":42,"phone":65,"phoneExt":66,"email":67},"Sierra Wilson","210-949-0122","208","SWilson@flourishresearch.com",{"name":69,"role":70,"phone":31,"phoneExt":31,"email":31},"Douglas Denham, DO","PRINCIPAL_INVESTIGATOR",{"type":72,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100557040","phase-1-a-study-to-evaluate-safety-tolerability-and-pharmacokinetics-of-mknd-201-in-healthy-volunteers-100557040",false,"NCT06532942","A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Nintedanib Inhalation Powder (MNKD-201) in Healthy Volunteers","Key Inclusion Criteria:\n\n* Is ≥40 and ≤65 years of age at the time of signing the informed consent form.\n* Has a negative urine test for selected drugs of abuse and negative alcohol test at screening and upon admission to the CRU on Day -1. Note: Participants should not consume poppy seeds within 24 hours before urine drug screening because this can falsify the results of the opiate urine drug test.\n* Is willing to adhere to the restrictions and requirements specified in the protocol.\n* Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test (i.e., the virus that causes COVID-19) on Day -1.\n* Is capable of performing spirometry, as required by the study procedures.\n\nKey Exclusion Criteria:\n\n* Has a history of significant lung disease (e.g., pulmonary fibrosis, cystic fibrosis, COPD, emphysema, chronic pulmonary infection, recent upper or lower respiratory tract infection in the prior 8 weeks, history of lung surgery or procedure, etc.)\n* Has endocrine, thyroid, or respiratory disease, diabetes mellitus, coronary heart disease, GI disease, or history of any psychotic mental illness.\n* Has a history of hepatic disease or has abnormal liver function tests (i.e., aspartate aminotransferase \\[AST\\] \\> 1.5 × upper limit of normal \\[ULN\\] or alanine aminotransferase \\[ALT\\] \\> 1.5 × ULN) at screening.\n* Has renal impairment (estimated glomerular filtration rate \\[eGFR\\] \\\u003C 60 mL\u002Fmin\u002F1.73 m2), as calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), at screening.\n* Has any history of pulmonary malignancy.\n* Has a history of substance abuse or dependency or history of recreational drug use over the last 2 years (by self-declaration).",true,"ALL","40 Years","65 Years",{"count":85,"type":86},40,"ESTIMATED","INTERVENTIONAL",[89],"PHASE1","MKC-NI-001 is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (MNKD-201) in healthy adult volunteers. The trial consists of a Single Ascending Dose (SAD), followed by a Multiple Ascending Dose (MAD) with a primary objective to evaluate the safety, tolerability, and pharmacokinetics (PK) of MNKD-201 compared to placebo in healthy adult participants.",[92],"Healthy Volunteers","2024-08-02",{"date":95,"type":96},"2024-08-06","ACTUAL",{"date":98,"type":96},"2024-05-28",{"date":100,"type":86},"2024-10-31",{"name":5,"class":6},1]