Trial Outcomes & Findings for A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibody (mAb) in Patients With IPF (SAD). (NCT NCT05513950)
NCT ID: NCT05513950
Last Updated: 2025-08-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
From pre-dose (baseline) up to day 84.
Results posted on
2025-08-14
Participant Flow
For the study, 52 male and female subjects were screened 3-28 days before randomization; of these, 27 subjects were screening failures. Overall, 25 subjects were randomized; of these 1 subject (CHF 10067 3000 mg) did not receive the study medication due to technical reasons.
Participant milestones
| Measure |
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
|
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
|
CHF 10067 3000 mg (Test Treatment)
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of a high dose of the monoclonal antibody
|
Placebo
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
7
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
CHF 10067 3000 mg (Test Treatment)
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of a high dose of the monoclonal antibody
|
Placebo
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
Overall Study
Not treated due to technical reasons
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Data available only for ex-smokers.
Baseline characteristics by cohort
| Measure |
CHF 10067 1000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody
|
CHF 10067 2000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody
|
CHF 10067 3000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody
|
Placebo
n=6 Participants
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 7.3 • n=6 Participants
|
61.8 years
STANDARD_DEVIATION 8.0 • n=6 Participants
|
58.7 years
STANDARD_DEVIATION 8.2 • n=6 Participants
|
70.7 years
STANDARD_DEVIATION 4.1 • n=6 Participants
|
63.0 years
STANDARD_DEVIATION 8.1 • n=24 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
8 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
16 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
24 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Body Mass Index (BMI)
|
25.98 kg/m^2
STANDARD_DEVIATION 2.17 • n=6 Participants
|
30.23 kg/m^2
STANDARD_DEVIATION 3.66 • n=6 Participants
|
30.02 kg/m^2
STANDARD_DEVIATION 4.18 • n=6 Participants
|
27.80 kg/m^2
STANDARD_DEVIATION 1.90 • n=6 Participants
|
28.51 kg/m^2
STANDARD_DEVIATION 3.42 • n=24 Participants
|
|
Smoking status at screening
Tobacco: Ex-smoker
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
13 Participants
n=24 Participants
|
|
Smoking status at screening
Tobacco: Non-smoker
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
11 Participants
n=24 Participants
|
|
Smoking status at screening
E-cigarettes: Ex-smoker
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Smoking status at screening
E-cigarettes: Non-smoker
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
24 Participants
n=24 Participants
|
|
Duration of smoking
|
40.3 years
STANDARD_DEVIATION 7.8 • n=3 Participants • Data available only for ex-smokers.
|
33.7 years
STANDARD_DEVIATION 16.3 • n=3 Participants • Data available only for ex-smokers.
|
21.7 years
STANDARD_DEVIATION 5.7 • n=3 Participants • Data available only for ex-smokers.
|
24.5 years
STANDARD_DEVIATION 16.3 • n=4 Participants • Data available only for ex-smokers.
|
29.6 years
STANDARD_DEVIATION 13.5 • n=13 Participants • Data available only for ex-smokers.
|
|
Number of pack-years
|
18.60 pack-years
STANDARD_DEVIATION 8.79 • n=3 Participants • Data available only for ex-smokers.
|
22.43 pack-years
STANDARD_DEVIATION 18.60 • n=3 Participants • Data available only for ex-smokers.
|
20.00 pack-years
STANDARD_DEVIATION 7.00 • n=3 Participants • Data available only for ex-smokers.
|
18.00 pack-years
STANDARD_DEVIATION 13.98 • n=4 Participants • Data available only for ex-smokers.
|
19.62 pack-years
STANDARD_DEVIATION 11.43 • n=13 Participants • Data available only for ex-smokers.
|
|
Time since diagnosis
|
1.25 years
n=6 Participants
|
0.79 years
n=6 Participants
|
1.21 years
n=6 Participants
|
1.40 years
n=6 Participants
|
1.00 years
n=24 Participants
|
|
Type of diagnosis
UIP pattern on available HRCT scan prior to screening
|
3 Participants
n=6 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
5 Participants
n=6 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
4 Participants
n=6 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
3 Participants
n=6 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
15 Participants
n=24 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
|
Type of diagnosis
Possible UIP pattern on available HRCT scan prior to screening
|
0 Participants
n=6 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
0 Participants
n=6 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
0 Participants
n=6 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
0 Participants
n=3 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
0 Participants
n=21 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
|
Type of diagnosis
Probable UIP pattern on available HRCT scan prior to screening. IPF confirmation: YES
|
3 Participants
n=6 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
1 Participants
n=6 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
2 Participants
n=6 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
3 Participants
n=6 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
9 Participants
n=24 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
|
Type of diagnosis
Probable UIP pattern HRCT scan prior to screening. Lung biopsy in accordance with HRCT: NA
|
3 Participants
n=3 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
1 Participants
n=1 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
2 Participants
n=2 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
3 Participants
n=3 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
9 Participants
n=9 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
|
Type of diagnosis
Probable UIP pattern HRCT scan prior to screening. Lung biopsy in accordance with HRCT: YES
|
0 Participants
n=3 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
1 Participants
n=1 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
1 Participants
n=2 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
2 Participants
n=3 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
4 Participants
n=9 Participants • Results are provided for subjects with relevant diagnostic data. IPF=Idiopathic pulmonary fibrosis; HRCT=High-resolution computed tomography; UIP=Usual interstitial pneumonia;
|
|
Antifibrotic treatment for IPF
NO
|
2 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
12 Participants
n=24 Participants
|
|
Antifibrotic treatment for IPF
YES
|
4 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
12 Participants
n=24 Participants
|
|
Antifibrotic treatment for IPF
Nintedanib
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
9 Participants
n=24 Participants
|
|
Antifibrotic treatment for IPF
Pirfenidone
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=24 Participants
|
|
Number of subjects with no exacerbations in the 3 months before screening
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
24 Participants
n=24 Participants
|
|
FEV1 actual value
|
2.190 liters
STANDARD_DEVIATION 0.343 • n=6 Participants
|
2.550 liters
STANDARD_DEVIATION 0.735 • n=6 Participants
|
2.107 liters
STANDARD_DEVIATION 0.628 • n=6 Participants
|
2.405 liters
STANDARD_DEVIATION 0.308 • n=6 Participants
|
2.313 liters
STANDARD_DEVIATION 0.530 • n=24 Participants
|
|
FEV1 % of predicted
|
69.90 % of predicted normal value
STANDARD_DEVIATION 11.28 • n=6 Participants
|
85.75 % of predicted normal value
STANDARD_DEVIATION 15.97 • n=6 Participants
|
77.67 % of predicted normal value
STANDARD_DEVIATION 13.64 • n=6 Participants
|
81.05 % of predicted normal value
STANDARD_DEVIATION 10.74 • n=6 Participants
|
78.59 % of predicted normal value
STANDARD_DEVIATION 13.55 • n=24 Participants
|
|
FVC actual value
|
2.818 liters
STANDARD_DEVIATION 0.385 • n=6 Participants
|
3.267 liters
STANDARD_DEVIATION 1.116 • n=6 Participants
|
2.632 liters
STANDARD_DEVIATION 0.914 • n=6 Participants
|
2.965 liters
STANDARD_DEVIATION 0.429 • n=6 Participants
|
2.920 liters
STANDARD_DEVIATION 0.762 • n=24 Participants
|
|
FVC % of predicted normal value
|
70.33 % of predicted normal value
STANDARD_DEVIATION 13.17 • n=6 Participants
|
85.23 % of predicted normal value
STANDARD_DEVIATION 20.15 • n=6 Participants
|
75.67 % of predicted normal value
STANDARD_DEVIATION 14.11 • n=6 Participants
|
75.72 % of predicted normal value
STANDARD_DEVIATION 10.57 • n=6 Participants
|
76.74 % of predicted normal value
STANDARD_DEVIATION 14.95 • n=24 Participants
|
PRIMARY outcome
Timeframe: From pre-dose (baseline) up to day 84.Population: Safety set: all randomised subjects who received a dose of study treatment, including partial dose.
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.
Outcome measures
| Measure |
CHF 10067 1000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody
|
CHF 10067 2000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody
|
CHF 10067 3000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody
|
Placebo
n=6 Participants
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
1_Subjects With Adverse Event (AE); Non-Serious AEs and Serious AEs
Serious TEAE
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
1_Subjects With Adverse Event (AE); Non-Serious AEs and Serious AEs
Non-serious TEAE
|
4 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
|
1_Subjects With Adverse Event (AE); Non-Serious AEs and Serious AEs
AE leading to study treatment discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
1_Subjects With Adverse Event (AE); Non-Serious AEs and Serious AEs
AE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.Population: 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.
Evaluate the area under the concentration-time curve (AUC) from zero to the last quantifiable concentration (AUC0-t) of CHF10067 after a single dose.
Outcome measures
| Measure |
CHF 10067 1000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody
|
CHF 10067 2000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody
|
CHF 10067 3000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody
|
Placebo
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
2_Systemic Exposure [Area Under the Concentration-time Curve From Zero to Time (AUC0-t)]
|
3424 day.μg/mL
Standard Deviation 647
|
7902 day.μg/mL
Standard Deviation 1001
|
15592 day.μg/mL
Standard Deviation 3027
|
—
|
SECONDARY outcome
Timeframe: 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.Population: 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.
Evaluate the area under the concentration-time curve (AUC) from zero to infinity (AUC0-∞) of CHF10067 after a single dose.
Outcome measures
| Measure |
CHF 10067 1000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody
|
CHF 10067 2000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody
|
CHF 10067 3000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody
|
Placebo
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
3_Area Under the Concentration-time Curve (AUC) From Zero to Infinity (AUC0-∞)
|
3450 day.μg/mL
Standard Deviation 660
|
8141 day.μg/mL
Standard Deviation 1112
|
16328 day.μg/mL
Standard Deviation 3245
|
—
|
SECONDARY outcome
Timeframe: 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.Population: 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.
Evaluate the Cmax (maximum observed concentration) after a single dose of CHF10067.
Outcome measures
| Measure |
CHF 10067 1000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody
|
CHF 10067 2000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody
|
CHF 10067 3000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody
|
Placebo
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
4_Pharmacokinetics -- Maximum Plasma Concentration (Cmax)
|
307 μg/mL
Standard Deviation 43.9
|
668 μg/mL
Standard Deviation 126
|
1067 μg/mL
Standard Deviation 173
|
—
|
SECONDARY outcome
Timeframe: 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.Population: 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.
Evaluate the time to maximum observed concentration (tmax).
Outcome measures
| Measure |
CHF 10067 1000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody
|
CHF 10067 2000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody
|
CHF 10067 3000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody
|
Placebo
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
5_Pharmacokinetics -- Time to Maximum Observed Concentration (Tmax)
|
1.69 hour
Interval 1.67 to 3.67
|
3.78 hour
Interval 3.58 to 11.67
|
5.39 hour
Interval 5.35 to 7.43
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion (up to 6 hours from the start of infusion).Population: 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.
Evaluate serum concentration at the end of infusion (Cinf) of CHF10067.
Outcome measures
| Measure |
CHF 10067 1000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody
|
CHF 10067 2000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody
|
CHF 10067 3000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody
|
Placebo
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
6_Pharmacokinetics -- Serum Concentration at the End of Infusion (Cinf)
|
304 μg/mL
Standard Deviation 44.6
|
658 μg/mL
Standard Deviation 138
|
1065 μg/mL
Standard Deviation 174
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion (up to 6 hours from the start of infusion).Population: 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.
Evaluate the time of serum concentration at the end of infusion (Tinf). Time at the end of the infusion.
Outcome measures
| Measure |
CHF 10067 1000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody
|
CHF 10067 2000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody
|
CHF 10067 3000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody
|
Placebo
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
7_Pharmacokinetics -- Time at the End of Infusion (Tinf)
|
1.68 hour
Interval 1.67 to 1.72
|
3.69 hour
Interval 3.58 to 3.85
|
5.38 hour
Interval 5.35 to 5.5
|
—
|
SECONDARY outcome
Timeframe: 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.Population: 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.
Evaluate clearance (CL) of CHF10067.
Outcome measures
| Measure |
CHF 10067 1000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody
|
CHF 10067 2000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody
|
CHF 10067 3000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody
|
Placebo
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
8_Pharmacokinetics -- Clearance (CL)
|
0.295 liter/day
Standard Deviation 0.0489
|
0.250 liter/day
Standard Deviation 0.0357
|
0.190 liter/day
Standard Deviation 0.0363
|
—
|
SECONDARY outcome
Timeframe: 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.Population: 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.
Evaluate volume of distribution (Vz) CHF10067.
Outcome measures
| Measure |
CHF 10067 1000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody
|
CHF 10067 2000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody
|
CHF 10067 3000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody
|
Placebo
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
9_Pharmacokinetics -- Volume of Distribution (Vz)
|
4.93 liter
Standard Deviation 0.969
|
5.99 liter
Standard Deviation 0.716
|
5.21 liter
Standard Deviation 1.03
|
—
|
SECONDARY outcome
Timeframe: From pre-dose (baseline) up to day 84.Population: 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.
Evaluate the terminal half-life (t1/2) of CHF10067.
Outcome measures
| Measure |
CHF 10067 1000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody
|
CHF 10067 2000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody
|
CHF 10067 3000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody
|
Placebo
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
10_Pharmacokinetics -- Terminal Half-life (t1/2)
|
11.7 days
Standard Deviation 2.20
|
16.8 days
Standard Deviation 2.32
|
19.1 days
Standard Deviation 1.93
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (baseline), and on 7, 28, 56, and 84 day post-dose.Population: Safety set: all subjects who were randomised and received a dose of study treatment, including partial dose.
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.
Outcome measures
| Measure |
CHF 10067 1000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody
|
CHF 10067 2000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody
|
CHF 10067 3000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody
|
Placebo
n=6 Participants
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
11_Spirometry -- Forced Expiratory Volume in the First Second (FEV1) -- Percent Predicted -- Change From Baseline
Day 7
|
3.93 percent predicted FEV1
Standard Deviation 3.35
|
0.50 percent predicted FEV1
Standard Deviation 2.74
|
-0.20 percent predicted FEV1
Standard Deviation 1.34
|
-0.43 percent predicted FEV1
Standard Deviation 2.60
|
|
11_Spirometry -- Forced Expiratory Volume in the First Second (FEV1) -- Percent Predicted -- Change From Baseline
Day 28
|
3.76 percent predicted FEV1
Standard Deviation 3.66
|
-0.55 percent predicted FEV1
Standard Deviation 3.06
|
-2.93 percent predicted FEV1
Standard Deviation 2.81
|
-0.55 percent predicted FEV1
Standard Deviation 3.37
|
|
11_Spirometry -- Forced Expiratory Volume in the First Second (FEV1) -- Percent Predicted -- Change From Baseline
Day 56
|
3.18 percent predicted FEV1
Standard Deviation 3.58
|
-0.68 percent predicted FEV1
Standard Deviation 3.54
|
-0.75 percent predicted FEV1
Standard Deviation 5.68
|
-1.35 percent predicted FEV1
Standard Deviation 2.93
|
|
11_Spirometry -- Forced Expiratory Volume in the First Second (FEV1) -- Percent Predicted -- Change From Baseline
Day 84
|
0.13 percent predicted FEV1
Standard Deviation 5.57
|
0.36 percent predicted FEV1
Standard Deviation 4.30
|
-2.70 percent predicted FEV1
Standard Deviation 2.93
|
-1.40 percent predicted FEV1
Standard Deviation 3.62
|
SECONDARY outcome
Timeframe: Text adjusted Pre-dose (baseline), and on 7, 28, 56, and 84 day post-dose.Population: Safety set: all subjects who were randomised and received a dose of study treatment, including partial dose.
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.
Outcome measures
| Measure |
CHF 10067 1000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody
|
CHF 10067 2000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody
|
CHF 10067 3000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody
|
Placebo
n=6 Participants
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
12_Spirometry -- Forced Vital Capacity (FVC) -- Percent Predicted -- Change From Baseline
Day 7
|
3.12 percent predicted FVC
Standard Deviation 2.24
|
-0.90 percent predicted FVC
Standard Deviation 3.31
|
-0.50 percent predicted FVC
Standard Deviation 2.89
|
-0.92 percent predicted FVC
Standard Deviation 3.80
|
|
12_Spirometry -- Forced Vital Capacity (FVC) -- Percent Predicted -- Change From Baseline
Day 28
|
2.70 percent predicted FVC
Standard Deviation 3.74
|
-0.50 percent predicted FVC
Standard Deviation 2.58
|
-3.23 percent predicted FVC
Standard Deviation 2.76
|
-0.13 percent predicted FVC
Standard Deviation 4.10
|
|
12_Spirometry -- Forced Vital Capacity (FVC) -- Percent Predicted -- Change From Baseline
Day 56
|
2.50 percent predicted FVC
Standard Deviation 1.87
|
-1.17 percent predicted FVC
Standard Deviation 3.12
|
-1.42 percent predicted FVC
Standard Deviation 6.55
|
-0.90 percent predicted FVC
Standard Deviation 2.84
|
|
12_Spirometry -- Forced Vital Capacity (FVC) -- Percent Predicted -- Change From Baseline
Day 84
|
-0.72 percent predicted FVC
Standard Deviation 4.02
|
-0.36 percent predicted FVC
Standard Deviation 3.56
|
-1.98 percent predicted FVC
Standard Deviation 3.79
|
-1.97 percent predicted FVC
Standard Deviation 3.22
|
SECONDARY outcome
Timeframe: From pre-dose (baseline) up to day 84.Population: Safety set: all subjects who were randomised and received a dose of study treatment, including partial dose.
Evaluate abnormal changes in systolic and diastolic blood pressure from baseline at any post-baseline time point.
Outcome measures
| Measure |
CHF 10067 1000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody
|
CHF 10067 2000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody
|
CHF 10067 3000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody
|
Placebo
n=6 Participants
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
13_Vital Signs -- Abnormal Changes in Systolic and Diastolic Blood Pressure
Systolic Blood Pressure Increase From Baseline >20 mmHg
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
13_Vital Signs -- Abnormal Changes in Systolic and Diastolic Blood Pressure
Systolic Blood Pressure Decrease From Baseline >20 mmHg
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
13_Vital Signs -- Abnormal Changes in Systolic and Diastolic Blood Pressure
Diastolic Blood Pressure Decrease From Baseline >10 mmHg
|
3 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
|
13_Vital Signs -- Abnormal Changes in Systolic and Diastolic Blood Pressure
Diastolic Blood Pressure Increase From Baseline >10 mmHg
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Pre-dose (baseline), at day 14, 28, 56, 84, and in case of early termination.Population: Safety set: all subjects who were randomised and received a dose of study treatment, including partial dose.
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.
Outcome measures
| Measure |
CHF 10067 1000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody
|
CHF 10067 2000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody
|
CHF 10067 3000 mg (Test Treatment)
n=6 Participants
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody
|
Placebo
n=6 Participants
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
14_Immunogenicity Profile -- Anti-drug Antibody (ADA) and Neutralising Antibody (nAb).
1_Baseline ADA positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
14_Immunogenicity Profile -- Anti-drug Antibody (ADA) and Neutralising Antibody (nAb).
2_ADA prevalence
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
14_Immunogenicity Profile -- Anti-drug Antibody (ADA) and Neutralising Antibody (nAb).
3_ADA incidence (ADA+)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
14_Immunogenicity Profile -- Anti-drug Antibody (ADA) and Neutralising Antibody (nAb).
4_Duration of ADA Persistently positive ADA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
14_Immunogenicity Profile -- Anti-drug Antibody (ADA) and Neutralising Antibody (nAb).
5_Duration of ADA Transiently positive ADA
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
14_Immunogenicity Profile -- Anti-drug Antibody (ADA) and Neutralising Antibody (nAb).
6_Treatment-boosted ADA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
14_Immunogenicity Profile -- Anti-drug Antibody (ADA) and Neutralising Antibody (nAb).
7_nAb positive at any visit
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
CHF 10067 1000 mg (Test Treatment)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CHF 10067 2000 mg (Test Treatment)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CHF 10067 3000 mg (Test Treatment)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CHF 10067 1000 mg (Test Treatment)
n=6 participants at risk
A single intravenous (IV) dose of CHF10067
CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody
|
CHF 10067 2000 mg (Test Treatment)
n=6 participants at risk
A single intravenous (IV) dose of CHF10067
CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody
|
CHF 10067 3000 mg (Test Treatment)
n=6 participants at risk
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody
|
Placebo
n=6 participants at risk
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
Other adverse events
| Measure |
CHF 10067 1000 mg (Test Treatment)
n=6 participants at risk
A single intravenous (IV) dose of CHF10067
CHF10067 starting dose: Intravenous administration of a starting dose of the monoclonal antibody
|
CHF 10067 2000 mg (Test Treatment)
n=6 participants at risk
A single intravenous (IV) dose of CHF10067
CHF10067 intermediate dose: Intravenous administration of an intermediate dose of the monoclonal antibody
|
CHF 10067 3000 mg (Test Treatment)
n=6 participants at risk
A single intravenous (IV) dose of CHF10067
CHF10067 high dose: Intravenous administration of an high dose of the monoclonal antibody
|
Placebo
n=6 participants at risk
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Placebo: Intravenous administration of a physiological solution as placebo
|
|---|---|---|---|---|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Eye disorders
Periorbital Oedema
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 4 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
General disorders
Medical Device Site Rash
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Infections and infestations
Gastroenteritis
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
33.3%
2/6 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
33.3%
2/6 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Infections and infestations
Tinea Pedis
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
16.7%
1/6 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
33.3%
2/6 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 3 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Renal and urinary disorders
Pollakiuria
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum Discoloured
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
33.3%
2/6 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
0.00%
0/6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all subjects who were randomised and received a dose of study treatment, including partial dose. Adverse events were analysed according to the treatment-emergent principle. The end of the study was defined as the last visit of the last subject in the study.
|
Additional Information
Clinical Trial Transparency
Chiesi Farmaceutici S.p.A.
Phone: + 39 0521 2791
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Results of this study may be published or presented at scientific meetings. If a publication is presented by the Investigator, the Investigator agrees to submit all manuscripts or abstracts to the Sponsor to Chiesi before submission.
- Publication restrictions are in place
Restriction type: OTHER