Trial Outcomes & Findings for A Phase 1b/2 Trial of the Safety and Microbiological Activity of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized With Pseudomonas Aeruginosa (NCT NCT05453578)
NCT ID: NCT05453578
Last Updated: 2026-07-16
Results Overview
An event that occurred during the treatment period was considered a treatment-emergent AE if it was not present before the first dose of investigational product or was present before the first dose of investigational product and increased in severity during the treatment period.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
73 participants
Primary outcome timeframe
Day 1 through Day 30
Results posted on
2026-07-16
Participant Flow
The study population included male and female adults, aged 18 or higher, with a confirmed cystic fibrosis diagnosis. Participants were enrolled from 03OCT2022 to 12MAR2025.
The sentinel stage (Stage 1) was neither randomized nor blinded, and participants were assigned to each IV bacteriophage dosage. As the Stage 1 arms were assigned their dosage, rather than randomized to it, they were not included in the Intent to Treat (ITT) population nor analyses.
Participant milestones
| Measure |
4x10^7 PFU - Stage 1
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
WRAIR-PAM-CF1: Bacteriophage combination composed of the following phages: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83, and PaWRA02Phi87.
|
4x10^8 PFU - Stage 1
4x10\^8 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
WRAIR-PAM-CF1: Bacteriophage combination composed of the following phages: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83, and PaWRA02Phi87.
|
4x10^9 PFU - Stage 1
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
WRAIR-PAM-CF1: Bacteriophage combination composed of the following phages: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83, and PaWRA02Phi87.
|
4x10^7 PFU - Stage 2a
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
WRAIR-PAM-CF1: Bacteriophage combination composed of the following phages: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83, and PaWRA02Phi87.
|
4x10^8 PFU - Stage 2a and 2b
4x10\^8 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
The efficacy comparison dose was determined after an interim analysis of Stage 2a data.
WRAIR-PAM-CF1: Bacteriophage combination composed of the following phages: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83, and PaWRA02Phi87.
|
4x10^9 PFU - Stage 2a
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
WRAIR-PAM-CF1: Bacteriophage combination composed of the following phages: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83, and PaWRA02Phi87.
|
Placebo - Stage 2a and 2b
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
Placebo: 0.9 percent sodium chloride
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
8
|
26
|
9
|
24
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
8
|
26
|
8
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
4x10^7 PFU - Stage 1
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
WRAIR-PAM-CF1: Bacteriophage combination composed of the following phages: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83, and PaWRA02Phi87.
|
4x10^8 PFU - Stage 1
4x10\^8 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
WRAIR-PAM-CF1: Bacteriophage combination composed of the following phages: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83, and PaWRA02Phi87.
|
4x10^9 PFU - Stage 1
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
WRAIR-PAM-CF1: Bacteriophage combination composed of the following phages: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83, and PaWRA02Phi87.
|
4x10^7 PFU - Stage 2a
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
WRAIR-PAM-CF1: Bacteriophage combination composed of the following phages: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83, and PaWRA02Phi87.
|
4x10^8 PFU - Stage 2a and 2b
4x10\^8 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
The efficacy comparison dose was determined after an interim analysis of Stage 2a data.
WRAIR-PAM-CF1: Bacteriophage combination composed of the following phages: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83, and PaWRA02Phi87.
|
4x10^9 PFU - Stage 2a
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
WRAIR-PAM-CF1: Bacteriophage combination composed of the following phages: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83, and PaWRA02Phi87.
|
Placebo - Stage 2a and 2b
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
Placebo: 0.9 percent sodium chloride
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Treatment not Administered
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Phase 1b/2 Trial of the Safety and Microbiological Activity of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized With Pseudomonas Aeruginosa
Baseline characteristics by cohort
| Measure |
4x10^7 PFU - Stage 1
n=2 Participants
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^8 PFU - Stage 1
n=2 Participants
4x10\^8 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 1
n=2 Participants
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^7 PFU - Stage 2a
n=8 Participants
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^8 PFU - Stage 2a and 2b
n=26 Participants
4x10\^8 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 2a
n=9 Participants
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
Placebo - Stage 2a and 2b
n=24 Participants
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 10.6 • n=9 Participants
|
49.0 years
STANDARD_DEVIATION 5.7 • n=27 Participants
|
32.0 years
STANDARD_DEVIATION 4.2 • n=267 Participants
|
36.3 years
STANDARD_DEVIATION 12.9 • n=265 Participants
|
45.3 years
STANDARD_DEVIATION 14.8 • n=568 Participants
|
38.7 years
STANDARD_DEVIATION 15.5 • n=22 Participants
|
40.8 years
STANDARD_DEVIATION 13.5 • n=23 Participants
|
42.2 years
STANDARD_DEVIATION 14.2 • n=22 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
12 Participants
n=568 Participants
|
2 Participants
n=22 Participants
|
15 Participants
n=23 Participants
|
36 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
14 Participants
n=568 Participants
|
7 Participants
n=22 Participants
|
9 Participants
n=23 Participants
|
37 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
2 Participants
n=22 Participants
|
2 Participants
n=23 Participants
|
7 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
8 Participants
n=265 Participants
|
23 Participants
n=568 Participants
|
7 Participants
n=22 Participants
|
22 Participants
n=23 Participants
|
66 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
5 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
7 Participants
n=265 Participants
|
24 Participants
n=568 Participants
|
8 Participants
n=22 Participants
|
21 Participants
n=23 Participants
|
64 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
3 Participants
n=22 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=9 Participants
|
2 participants
n=27 Participants
|
2 participants
n=267 Participants
|
8 participants
n=265 Participants
|
26 participants
n=568 Participants
|
9 participants
n=22 Participants
|
24 participants
n=23 Participants
|
73 participants
n=22 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 30Population: The intent-to-treat (ITT) set will consist of all randomized participants within 'Stage 2a' and 'Stage 2a and 2b', regardless of whether or not they received study product or placebo. Participants in Stage 1 arms are not randomized, and thus not included in ITT analyses.
An event that occurred during the treatment period was considered a treatment-emergent AE if it was not present before the first dose of investigational product or was present before the first dose of investigational product and increased in severity during the treatment period.
Outcome measures
| Measure |
Placebo - Stage 2a and 2b
n=26 Participants
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
4x10^7 PFU - Stage 2a
n=8 Participants
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 2a
n=8 Participants
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
Placebo - Stage 2a and 2b
n=24 Participants
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
|---|---|---|---|---|
|
Number of Participants That Experienced Grade 2 or Higher Treatment-emergent Adverse Events in the ITT Population
|
7 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Day 1 Post-infusion, Day 2, Day 5, Day 8, and Day 30Population: The intent-to-treat (ITT) set will consist of all randomized participants within 4x10\^8 PFU - Stage 2a and 2b and Placebo - Stage 2a and 2b, regardless of whether or not they received study product or placebo.
Mean change from baseline in log10-transformed counts of P. aeruginosa colony forming units per milliliter (CFU/mL) is presented for each time point through Day 30 as well as for each participant's minimum and maximum change from baseline. Undetectable colony counts are substituted with the limit of detection (LOD) of the assay (1 x 10\^4 CFU/mL).
Outcome measures
| Measure |
Placebo - Stage 2a and 2b
n=24 Participants
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
4x10^7 PFU - Stage 2a
n=26 Participants
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 2a
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
Placebo - Stage 2a and 2b
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
|---|---|---|---|---|
|
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo in Stage 2a and 2b
Maximum change
|
1.3 log10 (CFU/mL)
Standard Deviation 1.3
|
1.0 log10 (CFU/mL)
Standard Deviation 1.3
|
—
|
—
|
|
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo in Stage 2a and 2b
Minimum change
|
-0.7 log10 (CFU/mL)
Standard Deviation 1.3
|
-1.4 log10 (CFU/mL)
Standard Deviation 1.3
|
—
|
—
|
|
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo in Stage 2a and 2b
Day 2
|
0.3 log10 (CFU/mL)
Standard Deviation 1.4
|
-0.3 log10 (CFU/mL)
Standard Deviation 1.5
|
—
|
—
|
|
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo in Stage 2a and 2b
Day 5
|
0.3 log10 (CFU/mL)
Standard Deviation 1.4
|
-0.1 log10 (CFU/mL)
Standard Deviation 1.3
|
—
|
—
|
|
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo in Stage 2a and 2b
Day 8
|
0.2 log10 (CFU/mL)
Standard Deviation 1.7
|
-0.4 log10 (CFU/mL)
Standard Deviation 1.5
|
—
|
—
|
|
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo in Stage 2a and 2b
Day 30
|
0.5 log10 (CFU/mL)
Standard Deviation 1.7
|
0.0 log10 (CFU/mL)
Standard Deviation 1.7
|
—
|
—
|
|
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo in Stage 2a and 2b
Day 1 Post-infusion
|
0.1 log10 (CFU/mL)
Standard Deviation 1.4
|
0.0 log10 (CFU/mL)
Standard Deviation 1.2
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 Post-infusion, Day 2, Day 5, and Day 8Population: The intent-to-treat (ITT) set will consist of all randomized participants within 4x10\^8 PFU - Stage 2a and 2b and Placebo - Stage 2a and 2b, regardless of whether or not they received study product or placebo.
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated by: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1 x 10\^4 CFU/mL)
Outcome measures
| Measure |
Placebo - Stage 2a and 2b
n=24 Participants
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
4x10^7 PFU - Stage 2a
n=26 Participants
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 2a
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
Placebo - Stage 2a and 2b
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
|---|---|---|---|---|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 1 Post-infusion · Rank 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 1 Post-infusion · Rank 2
|
5 Participants
|
5 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 1 Post-infusion · Rank 3
|
18 Participants
|
21 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 1 Post-infusion · Rank 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 1 Post-infusion · Missing
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 2 · Rank 1
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 2 · Rank 2
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 2 · Rank 3
|
21 Participants
|
20 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 2 · Rank 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 2 · Missing
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 5 · Rank 1
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 5 · Rank 2
|
1 Participants
|
7 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 5 · Rank 3
|
21 Participants
|
18 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 5 · Rank 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 5 · Missing
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 8 · Rank 1
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 8 · Rank 2
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 8 · Rank 3
|
17 Participants
|
15 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 8 · Rank 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Day 8 · Missing
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Maximum · Rank 1
|
2 Participants
|
6 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Maximum · Rank 2
|
7 Participants
|
10 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Maximum · Rank 3
|
15 Participants
|
10 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Maximum · Rank 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Maximum · Missing
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 Post-infusion, Day 2, Day 5, Day 8, and Day 30Population: The intent-to-treat (ITT) set will consist of all randomized participants within 4x10\^8 PFU - Stage 2a and 2b and Placebo - Stage 2a and 2b, regardless of whether or not they received study product or placebo.
Mean change from baseline in log10-transformed counts of P. aeruginosa colony forming units per milliliter (CFU/mL) is presented for each time point through Day 30 as well as for each participant's minimum and maximum change from baseline. Undetectable colony counts are treated as missing.
Outcome measures
| Measure |
Placebo - Stage 2a and 2b
n=24 Participants
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
4x10^7 PFU - Stage 2a
n=26 Participants
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 2a
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
Placebo - Stage 2a and 2b
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
|---|---|---|---|---|
|
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo, Sensitivity Analysis for Stage 2a and 2b
Maximum change
|
1.0 log10 (CFU/mL)
Standard Deviation 1.2
|
0.7 log10 (CFU/mL)
Standard Deviation 1.0
|
—
|
—
|
|
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo, Sensitivity Analysis for Stage 2a and 2b
Day 30
|
0.1 log10 (CFU/mL)
Standard Deviation 1.6
|
-0.3 log10 (CFU/mL)
Standard Deviation 1.4
|
—
|
—
|
|
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo, Sensitivity Analysis for Stage 2a and 2b
Day 1 Post-infusion
|
0.1 log10 (CFU/mL)
Standard Deviation 1.1
|
-0.1 log10 (CFU/mL)
Standard Deviation 0.9
|
—
|
—
|
|
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo, Sensitivity Analysis for Stage 2a and 2b
Day 2
|
0.1 log10 (CFU/mL)
Standard Deviation 1.2
|
-0.5 log10 (CFU/mL)
Standard Deviation 1.1
|
—
|
—
|
|
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo, Sensitivity Analysis for Stage 2a and 2b
Day 5
|
0.3 log10 (CFU/mL)
Standard Deviation 1.3
|
-0.3 log10 (CFU/mL)
Standard Deviation 1.0
|
—
|
—
|
|
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo, Sensitivity Analysis for Stage 2a and 2b
Day 8
|
0.7 log10 (CFU/mL)
Standard Deviation 1.3
|
-0.6 log10 (CFU/mL)
Standard Deviation 1.3
|
—
|
—
|
|
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo, Sensitivity Analysis for Stage 2a and 2b
Minimum change
|
-0.7 log10 (CFU/mL)
Standard Deviation 1.2
|
-1.3 log10 (CFU/mL)
Standard Deviation 1.2
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 Post-infusion, Day 2, Day 5, and Day 8Population: The intent-to-treat (ITT) set will consist of all randomized participants within 4x10\^8 PFU - Stage 2a and 2b and Placebo - Stage 2a and 2b, regardless of whether or not they received study product or placebo.
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1 = No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3 = No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4 = SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Outcome measures
| Measure |
Placebo - Stage 2a and 2b
n=24 Participants
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
4x10^7 PFU - Stage 2a
n=26 Participants
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 2a
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
Placebo - Stage 2a and 2b
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
|---|---|---|---|---|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 1 Post-infusion · Rank 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 1 Post-infusion · Rank 2
|
4 Participants
|
4 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 1 Post-infusion · Rank 3
|
12 Participants
|
14 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 1 Post-infusion · Rank 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 1 Post-infusion · Missing
|
8 Participants
|
8 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 2 · Rank 1
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 2 · Rank 2
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 2 · Rank 3
|
13 Participants
|
14 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 2 · Rank 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 2 · Missing
|
10 Participants
|
9 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 5 · Rank 1
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 5 · Rank 2
|
1 Participants
|
6 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 5 · Rank 3
|
14 Participants
|
12 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 5 · Rank 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 5 · Missing
|
9 Participants
|
7 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 8 · Rank 1
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 8 · Rank 2
|
0 Participants
|
5 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 8 · Rank 3
|
12 Participants
|
9 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 8 · Rank 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Day 8 · Missing
|
12 Participants
|
10 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Maximum · Rank 1
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Maximum · Rank 2
|
5 Participants
|
10 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Maximum · Rank 3
|
11 Participants
|
6 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Maximum · Rank 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Maximum · Missing
|
8 Participants
|
7 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline through Day 8Population: The intent-to-treat (ITT) set will consist of all randomized participants within the 4x10\^8 PFU - Stage 2a and 2b and Placebo - Stage 2a and 2b, regardless of whether or not they received study product or placebo. The susceptible to 4-bacteriophage cocktail subgroup is used in this analysis. As prespecified, only participants within the 4x10\^8 PFU - Stage 2a and 2b and Placebo - Stage 2a and 2b were assessed for this Outcome Measure.
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated by: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1 x 10\^4 CFU/mL)
Outcome measures
| Measure |
Placebo - Stage 2a and 2b
n=24 Participants
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
4x10^7 PFU - Stage 2a
n=26 Participants
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 2a
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
Placebo - Stage 2a and 2b
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
|---|---|---|---|---|
|
Number of Susceptible to 4-bacteriophage Cocktail Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
|
13 Participants
|
12 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline through Day 8Population: The intent-to-treat (ITT) set will consist of all randomized participants within the 4x10\^8 PFU - Stage 2a and 2b and Placebo - Stage 2a and 2b, regardless of whether or not they received study product or placebo. The non-susceptible to 4-bacteriophage cocktail subgroup is used in this analysis. As prespecified, only participants within the 4x10\^8 PFU - Stage 2a and 2b and Placebo - Stage 2a and 2b were assessed for this Outcome Measure.
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and \>2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and \<1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10\^4 CFU/mL).
Outcome measures
| Measure |
Placebo - Stage 2a and 2b
n=24 Participants
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
4x10^7 PFU - Stage 2a
n=26 Participants
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 2a
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
Placebo - Stage 2a and 2b
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
|---|---|---|---|---|
|
Number of Non-susceptible to 4-bacteriophage Cocktail Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
|
11 Participants
|
14 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline through Day 8Population: This analysis includes a subgroup of the ITT set co-colonized with clinically meaningful organisms recovered from sputum cultures. Organisms included Achromobacter spanius, A. xylosoxidans, Burkholderia cenocepacia, B. vietnamiensis, Chryseobacterium indologenes, Pseudomonas koreensis, P. mendocina, and Stenotrophomonas maltophilia. As prespecified, only participants within the 4x10\^8 PFU-Stage 2a and 2b and Placebo-Stage 2a and 2b were assessed for this Outcome Measure.
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and \>2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and \<1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10\^4 CFU/mL).
Outcome measures
| Measure |
Placebo - Stage 2a and 2b
n=24 Participants
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
4x10^7 PFU - Stage 2a
n=26 Participants
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 2a
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
Placebo - Stage 2a and 2b
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
|---|---|---|---|---|
|
Number of Co-colonized With Clinically Meaningful Organism Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
|
2 Participants
|
7 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline through Day 8Population: This analysis includes a subgroup of the ITT set that was not co-colonized with clinically meaningful organisms recovered from sputum cultures. Organisms included Achromobacter spanius, A. xylosoxidans, Burkholderia cenocepacia, B. vietnamiensis, Chryseobacterium indologenes, Pseudomonas koreensis, P. mendocina, and Stenotrophomonas maltophilia. As prespecified, only participants within the 4x10\^8 PFU-Stage 2a and 2b and Placebo-Stage 2a and 2b were assessed for this Outcome Measure.
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and \>2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and \<1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10\^4 CFU/mL).
Outcome measures
| Measure |
Placebo - Stage 2a and 2b
n=24 Participants
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
4x10^7 PFU - Stage 2a
n=26 Participants
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 2a
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
Placebo - Stage 2a and 2b
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
|---|---|---|---|---|
|
Number of Not Co-colonized With Clinically Meaningful Organism Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
|
22 Participants
|
19 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline through Day 8Population: The intent-to-treat (ITT) set will consist of all randomized participants within 4x10\^8 PFU - Stage 2a and 2b and Placebo - Stage 2a and 2b, regardless of whether or not they received study product or placebo. The susceptible to 4-bacteriophage cocktail subgroup is used in this analysis. As prespecified, only participants within the 4x10\^8 PFU - Stage 2a and 2b and Placebo - Stage 2a and 2b were assessed for this Outcome Measure.
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1 = No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3 = No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4 = SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Outcome measures
| Measure |
Placebo - Stage 2a and 2b
n=13 Participants
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
4x10^7 PFU - Stage 2a
n=12 Participants
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 2a
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
Placebo - Stage 2a and 2b
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
|---|---|---|---|---|
|
Number of Susceptible to 4-bacteriophage Cocktail Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
Participants with Non-missing DOOR
|
9 Participants
|
8 Participants
|
—
|
—
|
|
Number of Susceptible to 4-bacteriophage Cocktail Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
Participants with Missing DOOR
|
4 Participants
|
4 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline through Day 8Population: The intent-to-treat (ITT) set will consist of all randomized participants within 4x10\^8 PFU - Stage 2a and 2b and Placebo - Stage 2a and 2b, regardless of whether or not they received study product or placebo. The non-susceptible to 4-bacteriophage cocktail subgroup is used in this analysis. As prespecified, only participants within the 4x10\^8 PFU - Stage 2a and 2b and Placebo - Stage 2a and 2b were assessed for this Outcome Measure.
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1 = No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3 = No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4 = SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Outcome measures
| Measure |
Placebo - Stage 2a and 2b
n=11 Participants
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
4x10^7 PFU - Stage 2a
n=14 Participants
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 2a
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
Placebo - Stage 2a and 2b
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
|---|---|---|---|---|
|
Number of Non-susceptible to 4-bacteriophage Cocktail Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
Participants with Non-missing DOOR
|
7 Participants
|
11 Participants
|
—
|
—
|
|
Number of Non-susceptible to 4-bacteriophage Cocktail Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
Participants with Missing DOOR
|
4 Participants
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline through Day 8Population: This analysis includes a subgroup of the ITT set co-colonized with clinically meaningful organisms recovered from sputum cultures. Organisms included Achromobacter spanius, A. xylosoxidans, Burkholderia cenocepacia, B. vietnamiensis, Chryseobacterium indologenes, Pseudomonas koreensis, P. mendocina, and Stenotrophomonas maltophilia. As prespecified, only participants within the 4x10\^8 PFU-Stage 2a and 2b and Placebo-Stage 2a and 2b were assessed for this Outcome Measure.
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1 = No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3 = No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4 = SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Outcome measures
| Measure |
Placebo - Stage 2a and 2b
n=2 Participants
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
4x10^7 PFU - Stage 2a
n=7 Participants
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 2a
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
Placebo - Stage 2a and 2b
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
|---|---|---|---|---|
|
Number of Co-colonized With Clinically Meaningful Organism Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
Participants With Non-missing DOOR
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Number of Co-colonized With Clinically Meaningful Organism Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
Participants With Missing DOOR
|
1 Participants
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline through Day 8Population: This analysis includes a subgroup of the ITT set that was not co-colonized with clinically meaningful organisms recovered from sputum cultures. Organisms included Achromobacter spanius, A. xylosoxidans, Burkholderia cenocepacia, B. vietnamiensis, Chryseobacterium indologenes, Pseudomonas koreensis, P. mendocina, and Stenotrophomonas maltophilia. As prespecified, only participants within the 4x10\^8 PFU-Stage 2a and 2b and Placebo-Stage 2a and 2b were assessed for this Outcome Measure.
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1 = No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3 = No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4 = SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Outcome measures
| Measure |
Placebo - Stage 2a and 2b
n=22 Participants
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
4x10^7 PFU - Stage 2a
n=19 Participants
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 2a
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
Placebo - Stage 2a and 2b
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
|---|---|---|---|---|
|
Number of Not Co-colonized With Clinically Meaningful Organism Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
Participants With Non-missing DOOR
|
15 Participants
|
15 Participants
|
—
|
—
|
|
Number of Not Co-colonized With Clinically Meaningful Organism Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
Participants with Missing DOOR
|
7 Participants
|
4 Participants
|
—
|
—
|
Adverse Events
4x10^7 PFU - Stage 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
4x10^8 PFU - Stage 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
4x10^9 PFU - Stage 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
4x10^7 PFU - Stage 2a
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
4x10^8 PFU - Stage 2a and 2b
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
4x10^9 PFU - Stage 2a
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo - Stage 2a and 2b
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
4x10^7 PFU - Stage 1
n=2 participants at risk
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^8 PFU - Stage 1
n=2 participants at risk
4x10\^8 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 1
n=2 participants at risk
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^7 PFU - Stage 2a
n=8 participants at risk
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^8 PFU - Stage 2a and 2b
n=26 participants at risk
4x10\^8 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 2a
n=8 participants at risk
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
Placebo - Stage 2a and 2b
n=24 participants at risk
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Cystic Fibrosis Pulmonary Exacerbation
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/26 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
12.5%
1/8 • Number of events 1 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/24 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
Other adverse events
| Measure |
4x10^7 PFU - Stage 1
n=2 participants at risk
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^8 PFU - Stage 1
n=2 participants at risk
4x10\^8 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 1
n=2 participants at risk
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^7 PFU - Stage 2a
n=8 participants at risk
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^8 PFU - Stage 2a and 2b
n=26 participants at risk
4x10\^8 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
4x10^9 PFU - Stage 2a
n=8 participants at risk
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage.
|
Placebo - Stage 2a and 2b
n=24 participants at risk
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage.
|
|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
50.0%
1/2 • Number of events 2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/26 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/24 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
50.0%
1/2 • Number of events 1 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/26 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
12.5%
3/24 • Number of events 3 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
50.0%
1/2 • Number of events 1 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/26 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/24 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
|
General disorders
Fatigue
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
12.5%
1/8 • Number of events 1 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/26 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/24 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
|
General disorders
Infusion Site Bruising
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
12.5%
1/8 • Number of events 1 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/26 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/24 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
|
Investigations
Fev1/Fvc Ratio Decreased
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/26 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
12.5%
1/8 • Number of events 1 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/24 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
12.5%
1/8 • Number of events 2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/26 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/24 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
|
Investigations
Blood Pressure Systolic Increased
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
15.4%
4/26 • Number of events 4 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
12.5%
3/24 • Number of events 3 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
12.5%
1/8 • Number of events 1 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/26 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/24 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/26 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
12.5%
1/8 • Number of events 1 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
8.3%
2/24 • Number of events 2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/26 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
12.5%
1/8 • Number of events 1 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
8.3%
2/24 • Number of events 2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
|
Cardiac disorders
Palpitations
|
50.0%
1/2 • Number of events 1 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/26 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/24 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
|
Gastrointestinal disorders
Abdominal Pain
|
50.0%
1/2 • Number of events 1 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/26 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/24 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/26 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/8 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/24 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
|
Infections and infestations
Infective Pulmonary Exacerbation Of Cystic Fibrosis
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
50.0%
1/2 • Number of events 1 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/2 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
12.5%
1/8 • Number of events 1 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
0.00%
0/26 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
12.5%
1/8 • Number of events 1 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
12.5%
3/24 • Number of events 4 • Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.
All Adverse Events (AEs) of Grade 2 or higher and Grade 1 AEs that were determined to be related to study product were collected. Participants were evaluated directly following study product administration. At follow-up visits, participants had safety labs collected in conjunction with participant reported symptoms and abnormalities.
|
Additional Information
Dr. Pranita Tamma
John Hopkins University School of Medicine
Phone: (410) 614-1492
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60