Trial Outcomes & Findings for Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis (NCT NCT04596319)
NCT ID: NCT04596319
Last Updated: 2024-01-31
Results Overview
Incidence and severity of treatment emergent adverse events of single and multiple doses of AP-PA02 administered by inhalation
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose.
Results posted on
2024-01-31
Participant Flow
Percentages were based on the number of subjects in the Safety Population in each treatment group. The Safety Population included all subjects who were administered at least 1 dose of study treatment.
Participant milestones
| Measure |
Cohort 1 SAD
3-phage (1x10\^10 PFU single dose)
|
Cohort 2 SAD
3-phage (3x10\^10 PFU single dose)
|
Amendment 5 MAD
3-phage multiple ascending dose (1E10 PFU/dose x3 doses/day x 3 days)
|
Cohort 3 MAD
5-phage (5.75x10\^10 PFU/dose x 2 doses/day x 5 days)
|
Cohort 4 MAD
5-phage (1.5x10\^11 PFU/dose x 2 doses/day x 10 days)
|
SAD Placebo
Single dose placebo
|
MAD Placebo
Multiple ascending dose placebo
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
2
|
3
|
10
|
3
|
5
|
|
Overall Study
COMPLETED
|
3
|
3
|
2
|
3
|
10
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Cohort 1 SAD
n=3 Participants
3-phage (1x10\^10 PFU single dose)
|
Cohort 2 SAD
n=3 Participants
3-phage (3x10\^10 PFU single dose)
|
Amendment 5 MAD
n=2 Participants
3-phage (1E10 PFU/dose x 3 doses/day x 3 days)
|
Cohort 3 MAD
n=3 Participants
5-phage (5.75x10\^10 PFU/dose x 2 doses/day x 5 days)
|
Cohort 4 MAD
n=10 Participants
5-phage (1.5x10\^11 PFU/dose x 2 doses/day x 10 days)
|
SAD Placebo
n=3 Participants
single dose placebo
|
MAD Placebo
n=5 Participants
multiple ascending dose placebo
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Age at screening
|
41.7 years
STANDARD_DEVIATION 3.21 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 6.03 • n=7 Participants
|
31.5 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 18.72 • n=4 Participants
|
38.2 years
STANDARD_DEVIATION 8.65 • n=21 Participants
|
39.6 years
STANDARD_DEVIATION 19.36 • n=10 Participants
|
47.8 years
STANDARD_DEVIATION 16.15 • n=115 Participants
|
40.8 years
STANDARD_DEVIATION 12.60 • n=24 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
16 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
13 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
29 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
28 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose.Incidence and severity of treatment emergent adverse events of single and multiple doses of AP-PA02 administered by inhalation
Outcome measures
| Measure |
MAD Placebo
n=5 Participants
multiple dose placebo
|
Cohort 1
n=3 Participants
3-phage (1x10\^10 PFU single dose)
|
Cohort 2
n=3 Participants
3-phage (3x10\^10 PFU single dose)
|
Amendment 5
n=2 Participants
3-phage multiple ascending dose (1E10 PFU/dose x3 doses/day x 3 days)
|
Cohort 3
n=3 Participants
5-phage (5.75x10\^10 PFU/dose x 2 doses/day x 5 days)
|
Cohort 4
n=10 Participants
5-phage (1.5x10\^11 PFU/dose x 2 doses/day x 10 days)
|
SAD Placebo
n=3 Participants
single dose placebo
|
|---|---|---|---|---|---|---|---|
|
Incidence and Severity Treatment Emergent Adverse Events (TEAEs)
Any TEAEs
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
|
Incidence and Severity Treatment Emergent Adverse Events (TEAEs)
Any serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence and Severity Treatment Emergent Adverse Events (TEAEs)
Any IMP-related TEAEs
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Incidence and Severity Treatment Emergent Adverse Events (TEAEs)
Any IMP-related serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence and Severity Treatment Emergent Adverse Events (TEAEs)
Any TEAEs with Grade 1 (mild) as the worst severity
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Incidence and Severity Treatment Emergent Adverse Events (TEAEs)
Any TEAEs with Grade 2 (moderate) as the worst severity
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence and Severity Treatment Emergent Adverse Events (TEAEs)
Any TEAEs with Grade 3 (severe) as the worst severity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence and Severity Treatment Emergent Adverse Events (TEAEs)
Any TEAEs with Grade 4 (life-threatening) as the worst severity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence and Severity Treatment Emergent Adverse Events (TEAEs)
Any TEAEs with Grade 5 (death) as the worst severity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1 SAD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2 SAD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Amendment 5 MAD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3 MAD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4 MAD
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
SAD Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MAD Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 SAD
n=3 participants at risk
3-phage (1x10\^10 PFU single dose)
|
Cohort 2 SAD
n=3 participants at risk
3-phage (3x10\^10 PFU single dose)
|
Amendment 5 MAD
n=2 participants at risk
3-phage multiple ascending dose (1E10 PFU/dose x3 doses/day x 3 days)
|
Cohort 3 MAD
n=3 participants at risk
5-phage (5.75x10\^10 PFU/dose x 2 doses/day x 5 days)
|
Cohort 4 MAD
n=10 participants at risk
5-phage (1.5x10\^11 PFU/dose x 2 doses/day x 10 days)
|
SAD Placebo
n=3 participants at risk
single dose placebo
|
MAD Placebo
n=5 participants at risk
multiple dose placebo
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
small intestinal obstruction
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
10.0%
1/10 • Number of events 1 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
Other adverse events
| Measure |
Cohort 1 SAD
n=3 participants at risk
3-phage (1x10\^10 PFU single dose)
|
Cohort 2 SAD
n=3 participants at risk
3-phage (3x10\^10 PFU single dose)
|
Amendment 5 MAD
n=2 participants at risk
3-phage multiple ascending dose (1E10 PFU/dose x3 doses/day x 3 days)
|
Cohort 3 MAD
n=3 participants at risk
5-phage (5.75x10\^10 PFU/dose x 2 doses/day x 5 days)
|
Cohort 4 MAD
n=10 participants at risk
5-phage (1.5x10\^11 PFU/dose x 2 doses/day x 10 days)
|
SAD Placebo
n=3 participants at risk
single dose placebo
|
MAD Placebo
n=5 participants at risk
multiple dose placebo
|
|---|---|---|---|---|---|---|---|
|
General disorders
chills
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
20.0%
2/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
General disorders
chest discomfort
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
10.0%
1/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
20.0%
1/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
General disorders
fatigue
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
10.0%
1/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
General disorders
pain
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
10.0%
1/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
General disorders
pyrexia
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
10.0%
1/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Infections and infestations
infective pulmonary exacerbation of cystic fibrosis
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
33.3%
1/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
10.0%
1/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
20.0%
1/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Infections and infestations
sialoadenitis
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
10.0%
1/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Infections and infestations
vulvovaginal mycotic infection
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
10.0%
1/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Infections and infestations
oral candidiasis
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
20.0%
1/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Injury, poisoning and procedural complications
ligament sprain
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
10.0%
1/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Injury, poisoning and procedural complications
soft tissue injury
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
10.0%
1/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Injury, poisoning and procedural complications
vaccination complication
|
33.3%
1/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
10.0%
1/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Gastrointestinal disorders
small intestinal obstruction
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
10.0%
1/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
10.0%
1/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
10.0%
1/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Nervous system disorders
headache
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
50.0%
1/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
10.0%
1/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
33.3%
1/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
40.0%
2/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Nervous system disorders
trigeminal neuralgia
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
10.0%
1/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Reproductive system and breast disorders
uterine polyp
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
33.3%
1/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
bronchial secretion retention
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
33.3%
1/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
40.0%
2/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
20.0%
1/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
20.0%
1/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
productive cough
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
20.0%
1/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
sputum increased
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
20.0%
1/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
|
Musculoskeletal and connective tissue disorders
Backache
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
50.0%
1/2 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/10 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/3 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
0.00%
0/5 • Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose
Adverse events were coded using MedDRA Version 23.0. At each level of summarization, subjects who experienced more than 1 event were counted only once.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The publications policy is also provided in the Clinical Trial Agreement. The data from this study will be available to the Investigators for publication upon the completion of the study. The Sponsor agrees to have the results published, whether positive or negative. The Sponsor will review any manuscripts to ensure that proprietary information has the appropriate patent protection prior to journal submission.
- Publication restrictions are in place
Restriction type: OTHER