AsthmaPhase 1NCT07851623
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 Phase 1 study testing CHF10136 in people with Asthma and Healthy Volunteers, run by Chiesi Farmaceutici S.p.A. at 3 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Healthy Volunteers
- What is being tested?
- CHF10136
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 2 Oct 2026to 27 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For PART 1 - SAD
- Healthy male or female participant ≥18 and ≤55 years of age
- Body mass index (BMI) ≥18 and ≤30 kg/m2 at screening and weight at least 50 kg;
- Good physical and mental status, determined via assessment of medical history at screening and physical examination at screening and prior to randomisation;
- Spirometry measurements within normal limits at screening and prior to randomisation based on the American Thoracic Society (ATS)/European 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/Forced Vital Capacity (FVC) ratio must be >0.7.
- Male and Female participants willing and able to comply with study procedures
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- For PART 2 - MAD
- Male or female participants ≥18 and ≤55 years of age at screening
- BMI ≥18 and ≤32 kg/m2 at screening and weight at least 50 kg;
- 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.
- Not currently receiving regular maintenance therapy for asthma, with no changes to treatment within <4 weeks prior to screening, and no exposure to ICS in the 12 weeks prior to screening including ICS reliever therapy;
- Pre-bronchodilator FEV1 ≥70% of predicted at the screening visit and prior to randomisation;
- Male and Female participants willing and able to comply with study procedures
- For PART 3 - REPEATED DOSE
- Male or female participants ≥18 and ≤65 years of age at screening
- BMI ≥18 and ≤35 kg/m2 at screening and weight at least 50 kg;
- 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.
- On a stable asthma treatment regimen of medium to high dose Inhaled Corticosteroids/Long-Acting Beta2-Agonists(ICS/LABA) (as defined by GINA 2026 guidelines) with no changes to treatment within 12 weeks prior to screening.
- Pre-bronchodilator FEV1 ≥40% and ≤90% of predicted at the screening visit and prior to randomisation;
- Asthma Control Questionnaire - 6 Items (ACQ-6) score of 0.5 to 3.0 at screening and prior to randomisation;
- Male and Female participants willing and able to comply with study procedures
Who cannot join
- For PART 1 - SAD
- Participation in another clinical study where investigational drug was received less than 90 days or 5 half-lives prior to screening, whichever is longer;
- 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;
- 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.
- Positive hepatitis panel and/or positive HIV test at the screening visit.
- 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);
Show all 35Show fewer
- History of malignancy within 5 years of screening (non-melanoma skin cancer is permitted if adequately treated for 12 months prior to screening);
- 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]).
- Known intolerance and/or hypersensitivity to the Investigational Medicinal Product (IMP) or to any of the excipients contained in the formulation used in the study;
- 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.
- For PART 2 - MAD
- Participation in another clinical study where investigational drug was received less than 90 days or 5 half-lives prior to screening, whichever is longer;
- 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;
- 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;
- 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.
- Positive hepatitis panel and/or positive HIV test at the screening visit.
- 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);
- Lower respiratory tract infection not resolved within 8 weeks prior to screening and/or randomisation, as determined by the Investigator;
- 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;
- Use of inhaled or systemic corticosteroids within 12 weeks of screening or prior to randomisation;
- 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);
- History of malignancy within 5 years of screening (non-melanoma skin cancer is permitted if adequately treated for 12 months prior to screening);
- Abnormal liver enzymes at screening or prior to randomisation (ALT or AST or total bilirubin:>1.0 × upper limit of normal [ULN]).
- 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.
- For PART 3 - REPEATED DOSE
- Participation in another clinical study where investigational drug was received less than 90 days or 5 half-lives prior to screening, whichever is longer;
- 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;
- 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;
- 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.
- Positive hepatitis panel and/or positive HIV test at the screening visit.
- 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);
- Asthma exacerbation or lower respiratory tract infection requiring medication or visit to the emergency department within 4 weeks prior to screening and/or prior to randomisation;
- Use of systemic corticosteroids within 8 weeks of screening or prior to randomisation;
- History of malignancy within 5 years of screening;
- 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;
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chiesi Clinical trial Info clinicaltrials_info@chiesi.com contact
United Kingdom3 sites, 3 recruiting
- Recruiting
Fortrea Leeds CRU
Leeds
- Not yet recruiting
hVIVO
London
- Not yet recruiting
MEU
Manchester
About this study
Official title: 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
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.
Read the detailed description
This is a first-in-human (FiH), randomized, double-blind, placebo-controlled study of CHF10136 administered via dry powder inhaler.
The 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.
Healthy 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.
- Conditions
- Asthma, Healthy Volunteers
- Being tested
- CHF10136, CHF10136 matched placebo
- Keywords
- Asthma, First in Human, Adults
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF10136Drug
CHF10136 powder for inhalation administered orally using a Dry Powder Inhaler.
CHF10136 matched placeboDrug
Matching placebo powder for inhalation administered using a Dry Powder Inhaler.
| Study group | Role | What they receive |
|---|---|---|
| CHF10136. | Experimental | Participants receive CHF10136 administered via dry powder inhaler. Doses vary according to study cohort. Receives: Drug: CHF10136 |
| Placebo | Placebo comparator | Participants receive placebo powder for inhalation administered via dry powder inhaler. Receives: Drug: CHF10136 matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events
Assessment of safety through collection of treatment-emergent adverse events.
Measured: 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)
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
Measured: 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)
Change From Baseline in Electrocardiogram Parameters: HR (Heart Rate)
Measured: 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)
Change From Baseline in Electrocardiogram Parameters: Intervals recorded: PR, QT, QRS duration, QTcF (Fridericia corrected QT interval)
Measured: Part 1: Day 1 to Day 2 - Part 2 & 3: Day 1 to Day N + 1 (Day after the last treatment intake)
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.
Number of subjects with abnormal urine laboratory test results.
Measured: 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)
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Measured: 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)
Secondary outcomes (9)
Area Under the Plasma Concentration-Time Curve (AUC) for CHF10136 (parent compound) and its main metabolite.)
Measured: Part 1: Up to 72 hours post-dose and on Day 1 - Part 2 & 3: Day N (the last day of treatment intake )
Maximum Observed Plasma Concentration (Cmax) of CHF10136 (parent compound) and its main metabolite.)
Measured: 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 )
Time to Maximum Plasma Concentration (Tmax) of CHF10136 (parent compound) and its main metabolite.)
Measured: 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 )
Terminal Half-Life (t½) of CHF10136 (parent compound) and its main metabolite.)
Measured: Day 1 for Part 1
Apparent Clearance (CL/F) of CHF10136 (parent compound) and its main metabolite.)
Measured: Up to 72 hours post-dose
Apparent Volume of Distribution (Vz/F) of CHF10136 (parent compound) and its main metabolite.)
Measured: Up to 72 hours post-dose
Pharmacokinetic Parameters of the main Metabolite
includes AUC
Measured: Up to 72 hours post-dose
Pharmacokinetic Parameters of the main Metabolite
includes Cmax
Measured: Up to 72 hours post-dose
Pharmacokinetic Parameters of the main Metabolite
include Metabolite Ratios
Measured: Up to 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start2 Oct 2026
- Primary completion27 Dec 2027 (estimated)
- Study completion27 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a randomized, double-blind, placebo-controlled first-in-human study using a sequential cohort dose-escalation design consisting of 3 parts. Participants within each cohort will be randomized to receive CHF10136 or matching placebo. The study includes: * Part 1 (SAD): Single Ascending Dose cohorts (6 cohorts) * Part 2 (MAD): Multiple Ascending Dose cohorts (4 cohorts) * Part 3 Repeated Dose cohort (1Cohort)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rory Taylor, MD, Study director, Chiesi Farmaceutici S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851623
- Sponsor's protocol ID
- CLI-10136AA1-01
- Other IDs
- 1014398
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07851623
- Acronym / sponsor ID
- CLI-10136AA1-01
- Conditions
- Asthma, Healthy Volunteers
- Keywords
- Asthma, First in Human, Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 2 Oct 2026 (actual)
- Primary completion
- 27 Dec 2027 (estimated)
- Study completion
- 27 Dec 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a first-in-human (FiH), randomized, double-blind, placebo-controlled study of CHF10136 administered via dry powder inhaler.
The 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.
Healthy 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, placebo-controlled first-in-human study using a sequential cohort dose-escalation design consisting of 3 parts. Participants within each cohort will be randomized to receive CHF10136 or matching placebo. The study includes: * Part 1 (SAD): Single Ascending Dose cohorts (6 cohorts) * Part 2 (MAD): Multiple Ascending Dose cohorts (4 cohorts) * Part 3 Repeated Dose cohort (1Cohort)
| Arm | Type | Receives |
|---|---|---|
| CHF10136. | Experimental | Drug: CHF10136Participants receive CHF10136 administered via dry powder inhaler. Doses vary according to study cohort. |
| Placebo | Placebo comparator | Drug: CHF10136 matched placeboParticipants receive placebo powder for inhalation administered via dry powder inhaler. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- For PART 1 - SAD
- Healthy male or female participant ≥18 and ≤55 years of age
- Body mass index (BMI) ≥18 and ≤30 kg/m2 at screening and weight at least 50 kg;
- Good physical and mental status, determined via assessment of medical history at screening and physical examination at screening and prior to randomisation;
- Spirometry measurements within normal limits at screening and prior to randomisation based on the American Thoracic Society (ATS)/European 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/Forced Vital Capacity (FVC) ratio must be >0.7.
Key exclusion criteria (35 listed)
- For PART 1 - SAD
- Participation in another clinical study where investigational drug was received less than 90 days or 5 half-lives prior to screening, whichever is longer;
- 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;
- 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.
- Positive hepatitis panel and/or positive HIV test at the screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHF10136CHF10136 powder for inhalation administered orally using a Dry Powder Inhaler. | Drug | CHF10136. |
| CHF10136 matched placeboMatching placebo powder for inhalation administered using a Dry Powder Inhaler. | Drug | Placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events
Time frame: 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)
Assessment of safety through collection of treatment-emergent adverse events.
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
Time frame: 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)
Change From Baseline in Electrocardiogram Parameters: HR (Heart Rate)
Time frame: 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)
Change From Baseline in Electrocardiogram Parameters: Intervals recorded: PR, QT, QRS duration, QTcF (Fridericia corrected QT interval)
Time frame: Part 1: Day 1 to Day 2 - Part 2 & 3: Day 1 to Day N + 1 (Day after the last treatment intake)
Change From Baseline in Clinical Laboratory Parameters
Time frame: 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)
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. Number of subjects with abnormal urine laboratory test results.
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Time frame: 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)
9 secondary outcomes
Area Under the Plasma Concentration-Time Curve (AUC) for CHF10136 (parent compound) and its main metabolite.)
Time frame: Part 1: Up to 72 hours post-dose and on Day 1 - Part 2 & 3: Day N (the last day of treatment intake )
Maximum Observed Plasma Concentration (Cmax) of CHF10136 (parent compound) and its main metabolite.)
Time frame: 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 )
Time to Maximum Plasma Concentration (Tmax) of CHF10136 (parent compound) and its main metabolite.)
Time frame: 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 )
Terminal Half-Life (t½) of CHF10136 (parent compound) and its main metabolite.)
Time frame: Day 1 for Part 1
Apparent Clearance (CL/F) of CHF10136 (parent compound) and its main metabolite.)
Time frame: Up to 72 hours post-dose
Apparent Volume of Distribution (Vz/F) of CHF10136 (parent compound) and its main metabolite.)
Time frame: Up to 72 hours post-dose
Pharmacokinetic Parameters of the main Metabolite
Time frame: Up to 72 hours post-dose
Pharmacokinetic Parameters of the main Metabolite
Time frame: Up to 72 hours post-dose
Pharmacokinetic Parameters of the main Metabolite
Time frame: Up to 72 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chiesi Clinical trial Info clinicaltrials_info@chiesi.com contact
Rory Taylor, MD study director
Chiesi Farmaceutici S.p.A.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHF10136 in people with Asthma and Healthy Volunteers, run by Chiesi Farmaceutici S.p.A. at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiesi Clinical trial Info clinicaltrials_info@chiesi.com (+390521279715, clinicaltrials_info@chiesi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (time frame: 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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.