An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. Safety population comprised of all participants who received at least one dose of study treatment during the study.

Safety Population.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.

Safety Population.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.

Safety Population.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.

Safety Population.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.

Safety Population.

PCI ranges for the hematology parameters were as follows: hematocrit (high: >0.54 proportion of red blood cell [RBC] in blood for male, >0.54 proportion of RBC in blood for female), hemoglobin (high: >180 grams [g]/L in male, >180 g/L in female), lymphocytes (low: <0.8 10^9/L), neutrophil count (low: <1.5 10^9/L) and platelet count (low: <100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.

Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.

PCI ranges for the hematology parameters were as follows: hematocrit (high: >0.54 proportion of RBC in blood for male, >0.54 proportion of RBC in blood for female), hemoglobin (high: >180 g/L in male, >180 g/L in female), lymphocytes (low: <0.8 10^9/L), neutrophil count (low: <1.5 10^9/L) and platelet count (low: <100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.

Safety Population.

PCI ranges for the hematology parameters were as follows: hematocrit (high: >0.54 proportion of RBC in blood for male, >0.54 proportion of RBC in blood for female), hemoglobin (high: >180 g/L in male, >180 g/L in female), lymphocytes (low: <0.8 10^9/L), neutrophil count (low: <1.5 10^9/L) and platelet count (low: <100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.

Safety Population.

PCI ranges for the clinical chemistry parameters were as follows: albumin (low: <30 millimole per liter [mmol/L]), calcium (low: <2 mmol/L and high: >2.75 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), potassium (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for the participants with high and low values has been reported.

Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.

PCI ranges for the clinical chemistry parameters were as follows: albumin (low: <30 mmol/L), calcium (low: <2 mmol/L and high: >2.75 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), potassium (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for the participants with high and low values has been reported.

Safety Population.

PCI ranges for the clinical chemistry parameters were as follows: albumin (low: <30 mmol/L), calcium (low: <2 mmol/L and high: >2.75 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), potassium (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for the participants with high and low values has been reported.

Safety Population.

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Safety Population.

Urine sample was collected from participants at indicated time point for analysis of pH.

Safety Population.

Urine samples were collected from participants at indicated time points for analysis of pH.

Safety Population.

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Safety Population.

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Safety Population.

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Safety Population.

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Safety Population.

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Safety Population.

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine sample was collected from participants at indicated time point for analysis of specific gravity.

Safety Population.

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity.

Safety Population.

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Safety Population.

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Safety Population.

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Safety Population.

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Safety Population.

PCI ranges for the ECG parameters were as follows: absolute QTc interval >450 and <480, >=480 and <500, >=500 milliseconds (msec), absolute PR interval <110 and >220 msec and absolute QRS interval <75 and >110 msec. QTcF=Frederica's QT interval corrected for heart rate; QTcB=Bazett's QT interval corrected for heart rate. Data for worst case post-Baseline has been reported.

Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.

PCI ranges for the ECG parameters were as follows: absolute QTc interval >450 and <480, >=480 and <500, >=500 msec, absolute PR interval <110 and >220 msec and absolute QRS interval <75 and >110 msec. Data for worst case post-Baseline has been reported.

Safety Population.

PCI ranges for the ECG parameters were as follows: absolute QTc interval >450 and <480, >=480 and <500, >=500 msec, absolute PR interval <110 and >220 msec and absolute QRS interval <75 and >110 msec. Data for worst case post-Baseline has been reported.

Safety Population.

Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.

Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)*100.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.

FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)*100.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.

FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)*100.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)*100.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

PCI ranges for the vital signs parameters were as follows: systolic blood pressure (SBP) <85 and >160 millimeters of mercury (mmHg), diastolic blood pressure (DBP) <45 and >100 mmHg and heart rate <40 and >110 beats per minute (bpm). Data for the participants with high and low values has been reported.

Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.

PCI ranges for the vital signs parameters were as follows: SBP <85 and >160 mmHg, DBP <45 and >100 mmHg and heart rate <40 and >110 bpm. Data for the participants with high and low values has been reported.

Safety Population.

PCI ranges for the vital signs parameters were as follows: SBP <85 and >160 mmHg, DBP <45 and >100 mmHg and heart rate <40 and >110 bpm. Data for the participants with high and low values has been reported.

Safety Population.

Blood samples were collected to evaluate the pharmacokinetics (PKs) of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data. PK population consisted of participants who received at least one dose of study treatment and who undergo plasma PK sampling and had at least one post-dose concentration result.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-t) data.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of Cmax data.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of tmax data.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-infinity) data.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.

PK Population. Only those participants with data available at the indicated time points were analyzed.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of t1/2 data.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.

PK Population. Only those participants with data available at the indicated time points were analyzed.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of CL/F data.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.

PK Population. Only those participants with data available at the indicated time points were analyzed.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of AUC(0-tau) data.

PK Population. NA indicates that, AUC(0-tau) could not be calculated because t1/2 considered unreliable as period over which they were calculated was less than twice resultant t1/2 in all cases. In addition, percent AUCextrapolated (%AUCex) was >20% in most cases. This was largely due to short period of sampling times.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.

PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.

PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of Cmax data.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.

PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.

PK Population. Only those participants with data available at the indicated time points were analyzed.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of tmax data.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.

PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.

PK Population.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of t1/2 data.

PK Population. NA indicates that, t1/2 of CCI15106 plasma concentration in healthy participant was estimated but considered unreliable as period over which they were calculated was less than twice resultant t1/2 in all cases. In addition, %AUCex was >20% in most cases. This was largely due to short period of sampling times.

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.

PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.

PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected from bystanders 15 minutes after dosing at indicated time points. Bystander PK population consisted of participants who were present at least once in the room with the participant receiving the dose, undergo plasma PK sampling and had post-dose concentration result.

Bystander PK Population. NA indicates that, data could not be analyzed because data was below level of quantification.

Personal exposure air samples were collected on filters placed on each bystander after the first daily dose at indicated time points. The filters were used to measure CCI15106 concentration in the person's breathing zone. Fixed location concentrations were measured near window, near door, back to wall and facing wall in the dosing room over 15 minutes post-dose. Each bystander had a filter attached to their study clothing. The filters were measured for CCI15106. This was a single measurement from the filter for each bystsander. The locations (near window, near door, back to wall and facing wall) were just to record where the bystander was located in the room.

Bystander PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Static air samples were collected on filters within air pumps positioned in two locations (bench and corner) in the room. Sampling devices attached to sampling pumps were used to measure CCI15106 concentration. Fixed location concentrations were measured in corner of room and on bench at back of room over 20 minutes and 60 minutes post-dosing.

Bystander PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Bronchoalveolar lavage samples for ELF concentration analysis of CCI15106 were collected up to Day 13. Participants who received at least one dose of study treatment and who underwent bronchoalveolar lavage (BAL) sampling and had post-dose lung ELF CCI15106 and urea concentration result were included in BAL PK Population.

BAL PK Population.

BAL samples for ELF concentration analysis of CCI15106 were collected up to Day 13.

BAL PK Population.

A medical device incident is any malfunction or deterioration in the characteristics and/or performance of a device as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a participant/user/other person or to a serious deterioration in his/her state of health.

Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.