Trial Outcomes & Findings for Study of Efficacy and Safety of ABO809 in Healthy Participants (NCT NCT05036668)
NCT ID: NCT05036668
Last Updated: 2024-10-02
Results Overview
Cryptosporidium infection was measured by examining the presence of a Cryptosporidium antigen in stool using a commercially available diagnostic Enzyme Immunoassay (EIA) test. Up to 3 stool samples per day were collected, each separated by approximately 4-hour intervals, were analyzed by EIA for parasitological assessment of oocyst shedding.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
At ≥72 hours post-administration (or sooner if associated with symptoms suggestive of diarrheal illness) up to Day 10 (inclusive).
Results posted on
2024-10-02
Participant Flow
Participants took part in one investigative site in one country.
Participant milestones
| Measure |
ABO809 1x10^4 CE-Cohort 1
ABO809 single oral dose of 1x10\^4 oocysts.
|
ABO809 1x10^6 CE-Cohort 2
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE-Cohort 3
ABO809 single oral dose of 1x10\^6 oocysts.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
ABO809 1x10^4 CE-Cohort 1
ABO809 single oral dose of 1x10\^4 oocysts.
|
ABO809 1x10^6 CE-Cohort 2
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE-Cohort 3
ABO809 single oral dose of 1x10\^6 oocysts.
|
|---|---|---|---|
|
Overall Study
lost to follow Up
|
0
|
0
|
1
|
Baseline Characteristics
Study of Efficacy and Safety of ABO809 in Healthy Participants
Baseline characteristics by cohort
| Measure |
ABO809 1x10^4 CE-Cohort 1
n=10 Participants
ABO809 single oral dose of 1x10\^4 oocysts.
|
ABO809 1x10^6 CE-Cohort 2
n=10 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE-Cohort 3
n=10 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 6.53 • n=5 Participants
|
33.4 years
STANDARD_DEVIATION 7.03 • n=7 Participants
|
34.1 years
STANDARD_DEVIATION 8.49 • n=5 Participants
|
33.9 years
STANDARD_DEVIATION 7.15 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At ≥72 hours post-administration (or sooner if associated with symptoms suggestive of diarrheal illness) up to Day 10 (inclusive).Population: The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data.
Cryptosporidium infection was measured by examining the presence of a Cryptosporidium antigen in stool using a commercially available diagnostic Enzyme Immunoassay (EIA) test. Up to 3 stool samples per day were collected, each separated by approximately 4-hour intervals, were analyzed by EIA for parasitological assessment of oocyst shedding.
Outcome measures
| Measure |
ABO809 1x10^4 CE-Cohort 1
n=10 Participants
ABO809 single oral dose of 1x10\^4 oocysts.
|
ABO809 1x10^6 CE-Cohort 2
n=7 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE-Cohort 3
n=10 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
|---|---|---|---|
|
Percentage of Participants With Cryptosporidium Infection From 72 Hours to 10 Days Post ABO809 Oral Administration
|
50 percentage of participants
Interval 26.73 to 73.27
|
57.1 percentage of participants
Interval 27.86 to 83.04
|
60.0 percentage of participants
Interval 35.42 to 81.24
|
SECONDARY outcome
Timeframe: From Day 1 up to Day 28Population: The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data.
Clinical diarrheal illness was defined as the occurrence of at least two diarrheal bowel events within 24 hours on at least two days after the administration of ABO809. Diarrhea is defined as at least one stool sample grading 3-5 on the Stool Grading system in one day. Grades 1 and 2 are considered normal stool and Grades 3-5 are considered diarrheal stool. Grade 1 stool is defined as formed stool which does not take the shape of the container. Grade 2 stool is defined as soft stool which does not easily take the shape of the container. Grade 3 diarrheal stool is defined as thick liquid stool taking the shape of the container. Grade 4 diarrheal stool is defined as opaque watery stool. Grade 5 diarrheal stool is defined as rice water or clear watery stools.
Outcome measures
| Measure |
ABO809 1x10^4 CE-Cohort 1
n=10 Participants
ABO809 single oral dose of 1x10\^4 oocysts.
|
ABO809 1x10^6 CE-Cohort 2
n=7 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE-Cohort 3
n=10 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
|---|---|---|---|
|
Percentage of Participants Showing Clinical Diarrheal Illness From Day 1 to Day 28 Post ABO809 Oral Administration
Clinical diarrheal illness up to Day 10 (inclusive)
|
60.0 percentage of participants
Interval 35.42 to 81.24
|
57.1 percentage of participants
Interval 27.86 to 83.04
|
50.0 percentage of participants
Interval 26.73 to 73.27
|
|
Percentage of Participants Showing Clinical Diarrheal Illness From Day 1 to Day 28 Post ABO809 Oral Administration
Clinical diarrheal illness up to Day 28 (inclusive)
|
60.0 percentage of participants
Interval 35.42 to 81.24
|
57.1 percentage of participants
Interval 27.86 to 83.04
|
50.0 percentage of participants
Interval 26.73 to 73.27
|
SECONDARY outcome
Timeframe: From Day 1 up to Day 28Population: The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data.
Diarrhea is defined as at least one stool sample grading 3-5 on the Stool Grading system in one day. Grades 1 and 2 are considered normal stool and Grades 3-5 are considered diarrheal stool. Grade 1 stool is defined as formed stool which does not take the shape of the container. Grade 2 stool is defined as soft stool which does not easily take the shape of the container. Grade 3 diarrheal stool is defined as thick liquid stool taking the shape of the container. Grade 4 diarrheal stool is defined as opaque watery stool. Grade 5 diarrheal stool is defined as rice water or clear watery stools.
Outcome measures
| Measure |
ABO809 1x10^4 CE-Cohort 1
n=10 Participants
ABO809 single oral dose of 1x10\^4 oocysts.
|
ABO809 1x10^6 CE-Cohort 2
n=7 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE-Cohort 3
n=10 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
|---|---|---|---|
|
Number of Diarrhea Stools Per Participant
|
13.3 diarrheal stools
Standard Error 4.85
|
16.2 diarrheal stools
Standard Error 7.15
|
12.9 diarrheal stools
Standard Error 3.41
|
SECONDARY outcome
Timeframe: From Day 1 up to Day 28Population: The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data.
Stool weight in grams of each stool from each participant were measured during inpatient period from Day 1 up to Day 10. Stool weight in grams of stool collected 24 hours prior to outpatient visit from each participant were measured during outpatient period from Day 14 to Day 28.
Outcome measures
| Measure |
ABO809 1x10^4 CE-Cohort 1
n=10 Participants
ABO809 single oral dose of 1x10\^4 oocysts.
|
ABO809 1x10^6 CE-Cohort 2
n=7 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE-Cohort 3
n=10 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
|---|---|---|---|
|
Overall Diarrheal Stool Weight
|
1614.0 grams
Standard Deviation 1541.84
|
2681.6 grams
Standard Deviation 2798.02
|
2877.0 grams
Standard Deviation 1884.71
|
SECONDARY outcome
Timeframe: From Day 1 up to Day 28All collected stool samples were graded according to the Stool Grading system. Grades 1 and 2 are considered normal stool and Grades 3-5 are considered diarrheal stool. Grades 3-5 stools are defined as thick liquid diarrhea taking the shape of the container, opaque watery, rice water or clear watery stools. The maximum stool grade is the highest stool grade of all episodes in a participant.
Outcome measures
| Measure |
ABO809 1x10^4 CE-Cohort 1
n=10 Participants
ABO809 single oral dose of 1x10\^4 oocysts.
|
ABO809 1x10^6 CE-Cohort 2
n=7 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE-Cohort 3
n=10 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
|---|---|---|---|
|
Maximum Stool Grade by Stool Grade Category
Stool Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Maximum Stool Grade by Stool Grade Category
Stool Grade 2
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Maximum Stool Grade by Stool Grade Category
Stool Grade >= 3
|
8 Participants
|
5 Participants
|
6 Participants
|
|
Maximum Stool Grade by Stool Grade Category
Stool Grade 1 and 2
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Maximum Stool Grade by Stool Grade Category
Stool Grade 3
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Maximum Stool Grade by Stool Grade Category
Stool Grade 4
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Maximum Stool Grade by Stool Grade Category
Stool Grade 5
|
3 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to Day 28Population: The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data.
Clinical diarrheal illness was defined as the occurrence of at least two diarrheal bowel events within 24 hours on at least two days after the administration of ABO809. The time to onset is the number of days until the start diarrheal illness.
Outcome measures
| Measure |
ABO809 1x10^4 CE-Cohort 1
n=6 Participants
ABO809 single oral dose of 1x10\^4 oocysts.
|
ABO809 1x10^6 CE-Cohort 2
n=4 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE-Cohort 3
n=5 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
|---|---|---|---|
|
Time to Onset of Clinical Diarrheal Illness
|
3.3 days
Standard Deviation 1.97
|
3.3 days
Standard Deviation 0.96
|
2.8 days
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: From Day 1 up to Day 28Population: The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data.
Clinical diarrheal illness was defined as the occurrence of at least two diarrheal bowel events within 24 hours on at least two days after the administration of ABO809. The time to resolution is the number of days until the resolution of diarrheal illness, which is defined as 2 or more consecutive days with no diarrheal stools (stool grades 1 or 2).
Outcome measures
| Measure |
ABO809 1x10^4 CE-Cohort 1
n=6 Participants
ABO809 single oral dose of 1x10\^4 oocysts.
|
ABO809 1x10^6 CE-Cohort 2
n=4 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE-Cohort 3
n=5 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
|---|---|---|---|
|
Time to Resolution of Clinical Diarrheal Illness
|
9.0 days
Standard Deviation 1.26
|
9.8 days
Standard Deviation 2.22
|
10.0 days
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: From Day 1 up to Day 28Population: Safety analysis set (SAF) included all participants that received one dose of ABO809 during the treatment period.
Clinical signs and symptoms associated with clinical diarrheal illness such as: abdominal pain, abdominal cramping, nausea, vomiting, fever, electrolyte disbalance, dehydration.
Outcome measures
| Measure |
ABO809 1x10^4 CE-Cohort 1
n=10 Participants
ABO809 single oral dose of 1x10\^4 oocysts.
|
ABO809 1x10^6 CE-Cohort 2
n=10 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE-Cohort 3
n=10 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
|---|---|---|---|
|
Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness
Abdominal distension
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness
Occult blood
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness
Abdominal discomfort
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness
Abdominal pain
|
5 Participants
|
7 Participants
|
2 Participants
|
|
Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness
Abdominal tenderness
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness
Defaecation urgency
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness
Flatulence
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness
Haematochezia
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness
Nausea
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness
Rectal tenesmus
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness
Vomiting
|
1 Participants
|
5 Participants
|
1 Participants
|
|
Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness
Pyrexia
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness
Occult blood positive
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness
Decreased appetite
|
2 Participants
|
6 Participants
|
4 Participants
|
|
Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness
Dehydration
|
2 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From 72 hours post-administration up to Day 28Population: The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data.
Percentage of participants with Cryptosporidium infection following an oral administration of ABO809. Cryptosporidium infection were measured by examining the presence of a Cryptosporidium antigen in stool using a commercially available diagnostic Enzyme Immunoassay (EIA) test.
Outcome measures
| Measure |
ABO809 1x10^4 CE-Cohort 1
n=10 Participants
ABO809 single oral dose of 1x10\^4 oocysts.
|
ABO809 1x10^6 CE-Cohort 2
n=7 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE-Cohort 3
n=10 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
|---|---|---|---|
|
Percentage of Participants With Cryptosporidium Infection From 72 Hours to Day 28 Post ABO809 Oral Administration
|
60.0 percentage of participants
Interval 35.42 to 81.24
|
57.1 percentage of participants
Interval 27.86 to 83.04
|
60 percentage of participants
Interval 35.42 to 81.24
|
SECONDARY outcome
Timeframe: From 72 hours post-administration up to Day 28Population: The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data.
Percentage of participants with fecal shedding of Cryptosporidium parvum oocysts following an oral administration of ABO809. Fecal shedding will be measured by examining the presence of a Cryptosporidium antigen in stool using a commercially available diagnostic Enzyme Immunoassay (EIA) test.
Outcome measures
| Measure |
ABO809 1x10^4 CE-Cohort 1
n=10 Participants
ABO809 single oral dose of 1x10\^4 oocysts.
|
ABO809 1x10^6 CE-Cohort 2
n=7 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE-Cohort 3
n=10 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
|---|---|---|---|
|
Percentage of Participants With Fecal Shedding of Cryptosporidium Parvum Oocysts
|
60.0 percentage of participants
Interval 35.42 to 81.24
|
57.1 percentage of participants
Interval 27.86 to 83.04
|
60.0 percentage of participants
Interval 35.42 to 81.24
|
SECONDARY outcome
Timeframe: From Day 1 up to Day 10Population: The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data. Only participants with an actual infection were included in the analysis.
Time to onset is the number of days until the start of Cryptosporidium infection which were measured by examining the presence of a Cryptosporidium antigen in stool using a commercially available diagnostic Enzyme Immunoassay (EIA) test.
Outcome measures
| Measure |
ABO809 1x10^4 CE-Cohort 1
n=5 Participants
ABO809 single oral dose of 1x10\^4 oocysts.
|
ABO809 1x10^6 CE-Cohort 2
n=4 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE-Cohort 3
n=6 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
|---|---|---|---|
|
Time to Onset of Cryptosporidium Infection
|
4.0 days
Standard Deviation 0.71
|
4.0 days
Standard Deviation 0.0
|
4.0 days
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: From Day 1 up to Day 28Population: The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data. Only participants with an actual infection were included in the analysis.
Time to resolution is the number of days until the resolution of Cryptosporidium infection in participants who developed an infection following an oral administration of ABO809. Resolution of Cryptosporidium infection is defined as no evidence of Cryptosporidium in stool samples collected over ≥2 consecutive days.
Outcome measures
| Measure |
ABO809 1x10^4 CE-Cohort 1
n=5 Participants
ABO809 single oral dose of 1x10\^4 oocysts.
|
ABO809 1x10^6 CE-Cohort 2
n=4 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE-Cohort 3
n=6 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
|---|---|---|---|
|
Time to Resolution of Cryptosporidium Infection
|
10.6 days
Standard Deviation 2.61
|
10.8 days
Standard Deviation 2.50
|
9.7 days
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.Population: The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data.
The following adverse events associated with Cryptosporidium infection are considered AESIs in this trial: Gastroenteritis in the absence of Cryptosporidium infection, extraintestinal cryptosporidiosis, persistent or recurrent cryptosporidiosis, persistent cryptosporidium shedding, moderate or severe dehydration and non-intestinal sequelae including eye pain or joint pain.
Outcome measures
| Measure |
ABO809 1x10^4 CE-Cohort 1
n=10 Participants
ABO809 single oral dose of 1x10\^4 oocysts.
|
ABO809 1x10^6 CE-Cohort 2
n=7 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE-Cohort 3
n=10 Participants
ABO809 single oral dose of 1x10\^6 oocysts.
|
|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Participants with AESI
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Moderate or severe dehydration
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Gastroenteritis in the absence of Cryptosporidium infection
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Extraintestinal cryptosporidiosis
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Persistent or recurrent cryptosporidosis
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Persistent cryptosporidium shedding
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Non-intestinal sequelae including eye pain or joint pain
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
ABO809 1x10^4 CE - Cohort 1
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
ABO809 1x10^6 CE-Cohort 2
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
ABO809 1x10^6 CE-Cohort 3
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
ABO809 1x10^6 CE - Cohorts 2 and 3
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Total
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ABO809 1x10^4 CE - Cohort 1
n=10 participants at risk
ABO809 single oral dose of 1x10\^4 oocysts.
|
ABO809 1x10^6 CE-Cohort 2
n=10 participants at risk
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE-Cohort 3
n=10 participants at risk
ABO809 single oral dose of 1x10\^6 oocysts.
|
ABO809 1x10^6 CE - Cohorts 2 and 3
n=20 participants at risk
ABO809 single oral dose of 1x10\^6 oocysts.
|
Total
n=30 participants at risk
Total
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Vascular disorders
Hot flush
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Cardiac disorders
Palpitations
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
60.0%
6/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
30.0%
3/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
45.0%
9/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
30.0%
9/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Gastrointestinal disorders
Abdominal distension
|
30.0%
3/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
13.3%
4/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
60.0%
6/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
70.0%
7/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
45.0%
9/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
50.0%
15/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
15.0%
3/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
3/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
2/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
3/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Gastrointestinal disorders
Defaecation urgency
|
40.0%
4/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
40.0%
4/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
30.0%
6/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
33.3%
10/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
80.0%
8/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
80.0%
8/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
60.0%
6/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
70.0%
14/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
73.3%
22/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
6.7%
2/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
4/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
6/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Gastrointestinal disorders
Haematochezia
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
30.0%
3/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
30.0%
3/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
30.0%
6/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
23.3%
7/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
40.0%
4/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
25.0%
5/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
26.7%
8/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
50.0%
5/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
30.0%
6/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
23.3%
7/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
General disorders
Chills
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
2/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
3/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
General disorders
Fatigue
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
General disorders
Pain
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
3/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
4/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
16.7%
5/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Investigations
Blood creatine phosphokinase increased
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
6.7%
2/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Investigations
Body temperature increased
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
30.0%
3/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
15.0%
3/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
3/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Investigations
Heart rate increased
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Investigations
Lipase increased
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Investigations
Occult blood
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
6.7%
2/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Investigations
Occult blood positive
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
6.7%
2/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
60.0%
6/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
40.0%
4/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
50.0%
10/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
40.0%
12/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
4/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
6/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.0%
3/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
4/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
23.3%
7/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
2/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
20.0%
4/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
13.3%
4/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Nervous system disorders
Headache
|
50.0%
5/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
60.0%
6/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
40.0%
4/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
50.0%
10/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
50.0%
15/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
10.0%
1/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
0.00%
0/10 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
5.0%
1/20 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
3.3%
1/30 • Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER