[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658413":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":63,"studyPopulation":15,"armGroups":64,"interventions":77,"overallOfficials":87,"centralContacts":91,"locations":97,"responsibleParty":125,"collaborators":15,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":15,"eligibilityCriteria":133,"healthyVolunteers":134,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":15,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":151,"whyStopped":15,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Chiesi Farmaceutici S.p.A.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":29,"otherOutcomes":15},[9,13,17,19,22,26],{"measure":10,"description":11,"timeFrame":12},"Number of Participants With Treatment-Emergent Adverse Events","Assessment of safety through collection of treatment-emergent adverse events.","Part 1, 2 and 3: Day - 28 to Day - 2 (Screening Visit), Day -1, Day 1, Day 2, Day 3, Day 4, and Day 8 (Follow-up Visit)",{"measure":14,"description":15,"timeFrame":16},"Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure",null,"Part 1, 2 and 3:Day - 28 to Day - 2 (Screening Visit), Day -1, Day 1, Day 2, Day 3, Day 4, and Day 8 (Follow-up Visit)",{"measure":18,"description":15,"timeFrame":16},"Change From Baseline in Electrocardiogram Parameters: HR (Heart Rate)",{"measure":20,"description":15,"timeFrame":21},"Change From Baseline in Electrocardiogram Parameters: Intervals recorded: PR, QT, QRS duration, QTcF (Fridericia corrected QT interval)","Part 1: Day 1 to Day 2 - Part 2 & 3: Day 1 to Day N + 1 (Day after the last treatment intake)",{"measure":23,"description":24,"timeFrame":25},"Change From Baseline in Clinical Laboratory Parameters","Number of subjects with abnormal blood laboratory test results. Quantitative laboratory parameters (chemistry and haematology) will be summarised by treatment as absolute value and change from baseline using descriptive statistics.\n\nNumber of subjects with abnormal urine laboratory test results.","Part 1: Screening visit, Day -1, Day 4 and Day 8 - Part 2 & 3: Screening Visit, Day -1, Day 4 , Day 7, Day N+1 (Day after the last treatment intake), Day N+7 (Follow-up Visit)",{"measure":27,"description":15,"timeFrame":28},"Change From Baseline in Forced Expiratory Volume in One Second (FEV1)","Part 1: Screening Visit, Day 1 and Day 2 - Part 2& 3: Screening Visit, Day -1, Day 1 and Day N (the last day of treatment intake)",[30,33,36,38,41,44,46,49,51],{"measure":31,"description":15,"timeFrame":32},"Area Under the Plasma Concentration-Time Curve (AUC) for CHF10136 (parent compound) and its main metabolite.)","Part 1: Up to 72 hours post-dose and on Day 1 - Part 2 & 3: Day N (the last day of treatment intake )",{"measure":34,"description":15,"timeFrame":35},"Maximum Observed Plasma Concentration (Cmax) of CHF10136 (parent compound) and its main metabolite.)","Part 1: on Day 1, up to 72 hours post-dose - Part 2 & 3: on Day 1 and Day N (the last day of treatment intake )",{"measure":37,"description":15,"timeFrame":35},"Time to Maximum Plasma Concentration (Tmax) of CHF10136 (parent compound) and its main metabolite.)",{"measure":39,"description":15,"timeFrame":40},"Terminal Half-Life (t½) of CHF10136 (parent compound) and its main metabolite.)","Day 1 for Part 1",{"measure":42,"description":15,"timeFrame":43},"Apparent Clearance (CL\u002FF) of CHF10136 (parent compound) and its main metabolite.)","Up to 72 hours post-dose",{"measure":45,"description":15,"timeFrame":43},"Apparent Volume of Distribution (Vz\u002FF) of CHF10136 (parent compound) and its main metabolite.)",{"measure":47,"description":48,"timeFrame":43},"Pharmacokinetic Parameters of the main Metabolite","includes AUC",{"measure":47,"description":50,"timeFrame":43},"includes Cmax",{"measure":47,"description":52,"timeFrame":43},"include Metabolite Ratios",{"allocation":54,"interventionModel":55,"interventionModelDescription":56,"primaryPurpose":57,"observationalModel":15,"timePerspective":15,"maskingInfo":58},"RANDOMIZED","SEQUENTIAL","This is a randomized, double-blind, placebo-controlled first-in-human study using a sequential cohort dose-escalation design consisting of 3 parts.\n\nParticipants within each cohort will be randomized to receive CHF10136 or matching placebo.\n\nThe study includes:\n\n* Part 1 (SAD): Single Ascending Dose cohorts (6 cohorts)\n* Part 2 (MAD): Multiple Ascending Dose cohorts (4 cohorts)\n* Part 3 Repeated Dose cohort (1Cohort)","TREATMENT",{"masking":59,"maskingDescription":15,"whoMasked":60},"DOUBLE",[61,62],"PARTICIPANT","INVESTIGATOR","This is a first-in-human (FiH), randomized, double-blind, placebo-controlled study of CHF10136 administered via dry powder inhaler.\n\nThe study consists of three sequential parts. Part 1 is a single ascending dose evaluation in healthy adult participants. Part 2 is a multiple ascending dose evaluation in participants with mild asthma. Part 3 is a repeated-dose evaluation in participants with moderate-to-severe asthma. Dose escalation and progression between study parts will occur following review of available safety and pharmacokinetic data.\n\nHealthy participants and participants with asthma will be enrolled and randomized to receive CHF10136 or placebo. Safety assessments, pharmacokinetic sampling, and exploratory pharmacodynamic assessments will be performed throughout the study.",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"CHF10136.","EXPERIMENTAL","Participants receive CHF10136 administered via dry powder inhaler. Doses vary according to study cohort.",[70],"Drug: CHF10136",{"label":72,"type":73,"description":74,"interventionNames":75},"Placebo","PLACEBO_COMPARATOR","Participants receive placebo powder for inhalation administered via dry powder inhaler.",[76],"Drug: CHF10136 matched placebo",[78,83],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":15},"DRUG","CHF10136","CHF10136 powder for inhalation administered orally using a Dry Powder Inhaler.",[66],{"type":79,"name":84,"description":85,"armGroupLabels":86,"otherNames":15},"CHF10136 matched placebo","Matching placebo powder for inhalation administered using a Dry Powder Inhaler.",[72],[88],{"name":89,"affiliation":5,"role":90},"Rory Taylor, MD","STUDY_DIRECTOR",[92],{"name":93,"role":94,"phone":95,"phoneExt":15,"email":96},"Chiesi Clinical trial Info clinicaltrials_info@chiesi.com","CONTACT","+390521279715","clinicaltrials_info@chiesi.com",[98,109,117],{"facility":99,"status":15,"city":100,"state":15,"zip":15,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":15},"Fortrea Leeds CRU","Leeds","United Kingdom","UK",{"type":104,"coordinates":105},"Point",[106,107],-1.54785,53.79648,{"lat":107,"lon":106},{"facility":110,"status":15,"city":111,"state":15,"zip":15,"country":101,"countryCode":102,"cosmosGeoPoint":112,"geoPoint":116,"contacts":15},"hVIVO","London",{"type":104,"coordinates":113},[114,115],-0.12574,51.50853,{"lat":115,"lon":114},{"facility":118,"status":15,"city":119,"state":15,"zip":15,"country":101,"countryCode":102,"cosmosGeoPoint":120,"geoPoint":124,"contacts":15},"MEU","Manchester",{"type":104,"coordinates":121},[122,123],-2.23743,53.48095,{"lat":123,"lon":122},{"type":126,"investigatorFullName":15,"investigatorTitle":15,"investigatorAffiliation":15,"oldNameTitle":15,"oldOrganization":15},"SPONSOR","100658413","phase-1-evaluation-of-safety-side-effects-and-how-the-drug-inhaled-chf10136-is-absorbed-modified-and-removed-from-the-body-in-healthy-adults-and-adults-with-asthma-100658413",false,"NCT07851623","Evaluation of Safety, Side Effects, and How the Drug, Inhaled CHF10136, Is Absorbed, Modified and Removed From the Body in Healthy Adults and Adults With Asthma","A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of CHF10136, Administered Via Dry Powder Inhaler, After Single Ascending Dose in Healthy Subjects, Multiple Ascending Doses in Mild Asthmatic Subjects and Followed by a Repeated Dose in One Cohort of Moderate-to-Severe Asthmatic Subjects","INCLUSION CRITERIA\n\nFor PART 1 - SAD\n\n* Healthy male or female participant ≥18 and ≤55 years of age\n* Body mass index (BMI) ≥18 and ≤30 kg\u002Fm2 at screening and weight at least 50 kg;\n* Good physical and mental status, determined via assessment of medical history at screening and physical examination at screening and prior to randomisation;\n* Spirometry measurements within normal limits at screening and prior to randomisation based on the American Thoracic Society (ATS)\u002FEuropean Respiratory Society (ERS) interpretative strategies for spirometry. The forced expiratory volume in the first second (FEV1) must be \\>80% of predicted normal value and the FEV1\u002FForced Vital Capacity (FVC) ratio must be \\>0.7.\n* Male and Female participants willing and able to comply with study procedures\n\nFor PART 2 - MAD\n\n* Male or female participants ≥18 and ≤55 years of age at screening\n* BMI ≥18 and ≤32 kg\u002Fm2 at screening and weight at least 50 kg;\n* Physician-diagnosed asthma for at least 6 months and before the age of 50 years. Documented evidence of one of the confirmed variable expiratory airflow criteria, as per the GINA 2026 guidelines, is required within 10 years prior to screening.\n* Not currently receiving regular maintenance therapy for asthma, with no changes to treatment within \\\u003C4 weeks prior to screening, and no exposure to ICS in the 12 weeks prior to screening including ICS reliever therapy;\n* Pre-bronchodilator FEV1 ≥70% of predicted at the screening visit and prior to randomisation;\n* Male and Female participants willing and able to comply with study procedures\n\nFor PART 3 - REPEATED DOSE\n\n* Male or female participants ≥18 and ≤65 years of age at screening\n* BMI ≥18 and ≤35 kg\u002Fm2 at screening and weight at least 50 kg;\n* Physician-diagnosed asthma for at least 6 months and before the age of 50 years. Documented evidence of one of the confirmed variable expiratory airflow criteria, as per the GINA 2026 guidelines, is required within 10 years prior to screening.\n* On a stable asthma treatment regimen of medium to high dose Inhaled Corticosteroids\u002FLong-Acting Beta2-Agonists(ICS\u002FLABA) (as defined by GINA 2026 guidelines) with no changes to treatment within 12 weeks prior to screening.\n* Pre-bronchodilator FEV1 ≥40% and ≤90% of predicted at the screening visit and prior to randomisation;\n* Asthma Control Questionnaire - 6 Items (ACQ-6) score of 0.5 to 3.0 at screening and prior to randomisation;\n* Male and Female participants willing and able to comply with study procedures\n\nEXCLUSION CRITERIA:\n\nFor PART 1 - SAD\n\n* Participation in another clinical study where investigational drug was received less than 90 days or 5 half-lives prior to screening, whichever is longer;\n* Clinically relevant respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, haematologic, metabolic, neurological or psychiatric disorders that may interfere with successful completion of this protocol, according to the Investigator's judgment;\n* Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation or which may impact the safety of the participant or the evaluation of the results of the study, according to the Investigator's judgment.\n* Positive hepatitis panel and\u002For positive HIV test at the screening visit.\n* Presence of any current infection, previous infection that resolved less than 7 days prior to screening or prior to randomisation or other latent or chronic infections (e.g. recurrent sinusitis, genital or ocular herpes, urinary tract infection);\n* History of malignancy within 5 years of screening (non-melanoma skin cancer is permitted if adequately treated for 12 months prior to screening);\n* Abnormal liver enzymes at screening or prior to randomisation (alanine aminotransferase \\[ALT\\] or aspartate aminotransferase \\[AST\\] or total bilirubin: \\>1.0 × upper limit of normal \\[ULN\\]).\n* Known intolerance and\u002For hypersensitivity to the Investigational Medicinal Product (IMP) or to any of the excipients contained in the formulation used in the study;\n* For females only: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until termination of the gestation.\n\nFor PART 2 - MAD\n\n* Participation in another clinical study where investigational drug was received less than 90 days or 5 half-lives prior to screening, whichever is longer;\n* Clinically relevant and uncontrolled respiratory disorders, including high-risk and non-persistent asthma; clinically relevant, uncontrolled, cardiac, hepatic, gastrointestinal, renal, endocrine, haematologic, metabolic, neurological or psychiatric disorders that may interfere with successful completion of this protocol, according to the Investigator's judgment;\n* History of any clinically significant respiratory disorders including but not limited to chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, alpha-1 antitrypsin deficiency, bronchiectasis, sarcoidosis, pulmonary hypertension or interstitial lung disease;\n* Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation or which may impact the safety of the participant or the evaluation of the results of the study, according to the Investigator's judgment.\n* Positive hepatitis panel and\u002For positive HIV test at the screening visit.\n* Presence of any current infection, previous infection that resolved less than 7 days prior to screening or prior to randomisation or other latent or chronic infections (e.g. recurrent sinusitis, genital or ocular herpes, urinary tract infection);\n* Lower respiratory tract infection not resolved within 8 weeks prior to screening and\u002For randomisation, as determined by the Investigator;\n* Asthma exacerbation requiring medication or visit to the emergency department, including increase in Short-Acting Beta-Agonists (SABA) use, within 8 weeks of screening or during the study;\n* Use of inhaled or systemic corticosteroids within 12 weeks of screening or prior to randomisation;\n* Use of any asthma controller medication within 4 weeks of screening or prior to randomisation (including, but not limited to, LABA, leukotriene antagonists, xanthines, anti-cholinergics);\n* History of malignancy within 5 years of screening (non-melanoma skin cancer is permitted if adequately treated for 12 months prior to screening);\n* Abnormal liver enzymes at screening or prior to randomisation (ALT or AST or total bilirubin:\\>1.0 × upper limit of normal \\[ULN\\]).\n* For females only: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until termination of the gestation.\n\nFor PART 3 - REPEATED DOSE\n\n* Participation in another clinical study where investigational drug was received less than 90 days or 5 half-lives prior to screening, whichever is longer;\n* Clinically relevant and uncontrolled respiratory disorders, including high-risk and non-persistent asthma; clinically relevant, uncontrolled, cardiac, hepatic, gastrointestinal, renal, endocrine, haematologic, metabolic, neurological or psychiatric disorders that may interfere with successful completion of this protocol, according to the Investigator's judgment;\n* History of any clinically significant respiratory disorders including but not limited to chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, alpha-1 antitrypsin deficiency, bronchiectasis, sarcoidosis, pulmonary hypertension or interstitial lung disease;\n* Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation or which may impact the safety of the participant or the evaluation of the results of the study, according to the Investigator's judgment.\n* Positive hepatitis panel and\u002For positive HIV test at the screening visit.\n* Presence of any current infection, previous infection that resolved less than 7 days prior to screening or prior to randomisation or other latent or chronic infections (e.g. recurrent sinusitis, genital or ocular herpes, urinary tract infection);\n* Asthma exacerbation or lower respiratory tract infection requiring medication or visit to the emergency department within 4 weeks prior to screening and\u002For prior to randomisation;\n* Use of systemic corticosteroids within 8 weeks of screening or prior to randomisation;\n* History of malignancy within 5 years of screening;\n* For females only: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until termination of the gestation;",true,"ALL","18 Years","65 Years",{"count":139,"type":140},120,"ESTIMATED","INTERVENTIONAL",[143],"PHASE1","This study evaluates the safety and tolerability of CHF10136 administered by inhalation in healthy adults and adults with asthma. The study includes single-dose, multiple-dose, and repeated-dose treatment periods and will also characterize the pharmacokinetic profile of CHF10136.",[146,147],"Asthma","Healthy Volunteers",[146,149,150],"First in Human","Adults","NOT_YET_RECRUITING","2026-09-25",{"date":154,"type":155},"2026-10-01","ACTUAL",{"date":154,"type":140},{"date":158,"type":140},"2027-12-27",{"name":5,"class":6},3]