| Primary | 1_Subjects With Adverse Event (AE); Non-Serious AEs and Serious AEs | Evaluate reported adverse events (AEs) and serious adverse events (SAEs). The number of subjects affected by AEs or SAEs is presented below. Please note: comprehensive summaries of AEs and SAEs are presented in section 'Adverse Events'; these include the preferred term of the AE or SAE, the number of subjects affected, and the number of events for a each preferred term. | Safety set: all randomised subjects who received a dose of study treatment, including partial dose. | Posted | | Count of Participants | | Participants | | From pre-dose (baseline) up to day 84. | | | | ID | Title | Description |
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| OG000 | CHF 10067 1000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody | | OG001 | CHF 10067 2000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody | | OG002 | CHF 10067 3000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody | | OG003 | Placebo | A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution) Placebo: Intravenous administration of a physiological solution as placebo |
| | | Title | Denominators | Categories |
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| Serious TEAE | | |
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| Secondary | 2_Systemic Exposure [Area Under the Concentration-time Curve From Zero to Time (AUC0-t)] | Evaluate the area under the concentration-time curve (AUC) from zero to the last quantifiable concentration (AUC0-t) of CHF10067 after a single dose. | Pharmacokinetic set (PK set): all subjects from the safety set, excluding subjects without any valid PK measurement or with important protocol deviations significantly affecting PK, for example, use of non-permitted medications. | Posted | | Mean | Standard Deviation | day.μg/mL | | Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion, 2, 4, 8, and 20 h after the end of infusion and 5, 7, 14, 28, 56, and 84 days post-dose. | | | | ID | Title | Description |
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| OG000 | CHF 10067 1000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody | | OG001 | CHF 10067 2000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody | | OG002 | CHF 10067 3000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody |
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| Secondary | 3_Area Under the Concentration-time Curve (AUC) From Zero to Infinity (AUC0-∞) | Evaluate the area under the concentration-time curve (AUC) from zero to infinity (AUC0-∞) of CHF10067 after a single dose. | Pharmacokinetic set (PK set): all subjects from the safety set, excluding subjects without any valid PK measurement or with important protocol deviations significantly affecting PK, for example, use of non-permitted medications. | Posted | | Mean | Standard Deviation | day.μg/mL | | Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion, 2, 4, 8, and 20 h after the end of infusion and 5, 7, 14, 28, 56, and 84 days post-dose. | | | | ID | Title | Description |
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| OG000 | CHF 10067 1000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody | | OG001 | CHF 10067 2000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody | | OG002 | CHF 10067 3000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody |
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| Secondary | 4_Pharmacokinetics -- Maximum Plasma Concentration (Cmax) | Evaluate the Cmax (maximum observed concentration) after a single dose of CHF10067. | Pharmacokinetic set (PK set): all subjects from the safety set, excluding subjects without any valid PK measurement or with important protocol deviations significantly affecting PK, for example, use of non-permitted medications. | Posted | | Mean | Standard Deviation | μg/mL | | Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion, 2, 4, 8, and 20 h after the end of infusion and 5, 7, 14, 28, 56, and 84 days post-dose. | | | | ID | Title | Description |
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| OG000 | CHF 10067 1000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody | | OG001 | CHF 10067 2000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody | | OG002 | CHF 10067 3000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody |
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| Secondary | 5_Pharmacokinetics -- Time to Maximum Observed Concentration (Tmax) | Evaluate the time to maximum observed concentration (tmax). | Pharmacokinetic set (PK set): all subjects from the safety set, excluding subjects without any valid PK measurement or with important protocol deviations significantly affecting PK, for example, use of non-permitted medications. | Posted | | Median | Full Range | hour | | Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion, 2, 4, 8, and 20 h after the end of infusion and 5, 7, 14, 28, 56, and 84 days post-dose. | | | | ID | Title | Description |
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| OG000 | CHF 10067 1000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody | | OG001 | CHF 10067 2000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody | | OG002 | CHF 10067 3000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody |
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| Secondary | 6_Pharmacokinetics -- Serum Concentration at the End of Infusion (Cinf) | Evaluate serum concentration at the end of infusion (Cinf) of CHF10067. | Pharmacokinetic set (PK set): all subjects from the safety set, excluding subjects without any valid PK measurement or with important protocol deviations significantly affecting PK, for example, use of non-permitted medications. | Posted | | Mean | Standard Deviation | μg/mL | | Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion (up to 6 hours from the start of infusion). | | | | ID | Title | Description |
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| OG000 | CHF 10067 1000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody | | OG001 | CHF 10067 2000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody | | OG002 | CHF 10067 3000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody |
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| Secondary | 7_Pharmacokinetics -- Time at the End of Infusion (Tinf) | Evaluate the time of serum concentration at the end of infusion (Tinf). Time at the end of the infusion. | Pharmacokinetic set (PK set): all subjects from the safety set, excluding subjects without any valid PK measurement or with important protocol deviations significantly affecting PK, for example, use of non-permitted medications. | Posted | | Median | Full Range | hour | | Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion (up to 6 hours from the start of infusion). | | | | ID | Title | Description |
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| OG000 | CHF 10067 1000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody | | OG001 | CHF 10067 2000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody | | OG002 | CHF 10067 3000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody |
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| Secondary | 8_Pharmacokinetics -- Clearance (CL) | Evaluate clearance (CL) of CHF10067. | Pharmacokinetic set (PK set): all subjects from the safety set, excluding subjects without any valid PK measurement or with important protocol deviations significantly affecting PK, for example, use of non-permitted medications. | Posted | | Mean | Standard Deviation | liter/day | | Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion, 2, 4, 8, and 20 h after the end of infusion and 5, 7, 14, 28, 56, and 84 days post-dose. | | | | ID | Title | Description |
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| OG000 | CHF 10067 1000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody | | OG001 | CHF 10067 2000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody | | OG002 | CHF 10067 3000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody |
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| Secondary | 9_Pharmacokinetics -- Volume of Distribution (Vz) | Evaluate volume of distribution (Vz) CHF10067. | Pharmacokinetic set (PK set): all subjects from the safety set, excluding subjects without any valid PK measurement or with important protocol deviations significantly affecting PK, for example, use of non-permitted medications. | Posted | | Mean | Standard Deviation | liter | | Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion, 2, 4, 8, and 20 h after the end of infusion and 5, 7, 14, 28, 56, and 84 days post-dose. | | | | ID | Title | Description |
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| OG000 | CHF 10067 1000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody | | OG001 | CHF 10067 2000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody | | OG002 | CHF 10067 3000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody |
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| Secondary | 10_Pharmacokinetics -- Terminal Half-life (t1/2) | Evaluate the terminal half-life (t1/2) of CHF10067. | Pharmacokinetic set (PK set): all subjects from the safety set, excluding subjects without any valid PK measurement or with important protocol deviations significantly affecting PK, for example, use of non-permitted medications. | Posted | | Mean | Standard Deviation | days | | From pre-dose (baseline) up to day 84. | | | | ID | Title | Description |
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| OG000 | CHF 10067 1000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody | | OG001 | CHF 10067 2000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody | | OG002 | CHF 10067 3000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody |
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| Secondary | 11_Spirometry -- Forced Expiratory Volume in the First Second (FEV1) -- Percent Predicted -- Change From Baseline | Forced expiratory volume in the first second (FEV1) parameters, summarised using descriptive statistics at each analysis time point by treatment. Summary results show the change from baseline of the percent predicted. | Safety set: all subjects who were randomised and received a dose of study treatment, including partial dose. | Posted | | Mean | Standard Deviation | percent predicted FEV1 | | Pre-dose (baseline), and on 7, 28, 56, and 84 day post-dose. | | | | ID | Title | Description |
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| OG000 | CHF 10067 1000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody | | OG001 | CHF 10067 2000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody | | OG002 | CHF 10067 3000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody |
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| Secondary | 12_Spirometry -- Forced Vital Capacity (FVC) -- Percent Predicted -- Change From Baseline | Forced vital capacity (FVC) parameters will be summarised using descriptive statistics at each analysis time point by treatment. Summary results show the change from baseline of the percent predicted. | Safety set: all subjects who were randomised and received a dose of study treatment, including partial dose. | Posted | | Mean | Standard Deviation | percent predicted FVC | | Text adjusted Pre-dose (baseline), and on 7, 28, 56, and 84 day post-dose. | | | | ID | Title | Description |
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| OG000 | CHF 10067 1000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody | | OG001 | CHF 10067 2000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody | | OG002 | CHF 10067 3000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody | |
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| Secondary | 13_Vital Signs -- Abnormal Changes in Systolic and Diastolic Blood Pressure | Evaluate abnormal changes in systolic and diastolic blood pressure from baseline at any post-baseline time point. | Safety set: all subjects who were randomised and received a dose of study treatment, including partial dose. | Posted | | Count of Participants | | Participants | | From pre-dose (baseline) up to day 84. | | | | ID | Title | Description |
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| OG000 | CHF 10067 1000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody | | OG001 | CHF 10067 2000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody | | OG002 | CHF 10067 3000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody | | OG003 | Placebo | |
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| Secondary | 14_Immunogenicity Profile -- Anti-drug Antibody (ADA) and Neutralising Antibody (nAb). | Evaluate the immunogenicity profile of CHF 10067 in serum, with respect to the development of anti-drug antibody (ADA) and neutralising antibody (nAb). A robust immunogenicity profile indicates the potential for the drug to trigger an immune response in patients, leading to the formation of ADAs. These antibodies can affect the drug's efficacy, safety, and pharmacokinetics. Detecting the presence of ADAs in serum samples was performed using an enzyme linked immunosorbent assay (ELISA), a validated assay method. Neutralizing Antibody (nAb) are a subset of ADAs that can interfere with the drug's therapeutic activity by blocking its binding to the target or inhibiting its downstream effects. The presence of ADAs and nAbs can affect the drug's pharmacokinetics (PK) by altering its absorption, distribution, metabolism, and excretion. This can lead to changes in drug exposure and potentially impact efficacy and safety. | Safety set: all subjects who were randomised and received a dose of study treatment, including partial dose. | Posted | | Count of Participants | | Participants | | Pre-dose (baseline), at day 14, 28, 56, 84, and in case of early termination. | | | | ID | Title | Description |
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| OG000 | CHF 10067 1000 mg (Test Treatment) | A single intravenous (IV) dose of CHF10067 CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody | | OG001 | CHF 10067 2000 mg (Test Treatment) | |
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