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

NCT07851623 | Not Yet Recruiting Phase 1

• 2 other identifiers: CLI-10136AA1-011014398
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Asthma; Healthy Volunteers

Keywords

Asthma; First in Human; Adults

Outcome Measures

Primary Outcomes (6)

• 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)

• Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure

  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)

  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)

  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.

  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)

  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.)

  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.)

  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.)

  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.)

  Day 1 for Part 1

• Apparent Clearance (CL/F) of CHF10136 (parent compound) and its main metabolite.)

  Up to 72 hours post-dose

Study Arms (2)

CHF10136.

EXPERIMENTAL

Participants receive CHF10136 administered via dry powder inhaler. Doses vary according to study cohort.

Drug: CHF10136

Placebo

PLACEBO COMPARATOR

Participants receive placebo powder for inhalation administered via dry powder inhaler.

Drug: CHF10136 matched placebo

Interventions

CHF10136 DRUG

CHF10136 powder for inhalation administered orally using a Dry Powder Inhaler.

CHF10136.

CHF10136 matched placebo DRUG

Matching placebo powder for inhalation administered using a Dry Powder Inhaler.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (3)

Fortrea Leeds CRU

Leeds, United Kingdom

Location

hVIVO

London, United Kingdom

Location

MEU

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Rory Taylor, MD

  Chiesi Farmaceutici S.p.A.

  STUDY DIRECTOR

Central Study Contacts

Chiesi Clinical trial Info clinicaltrials_info@chiesi.com

CONTACT

+390521279715; clinicaltrials_info@chiesi.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 27, 2027
• Study Completion (Estimated): December 27, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)