Trial Outcomes & Findings for A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease (NCT NCT06001177)
NCT ID: NCT06001177
Last Updated: 2025-12-18
Results Overview
KAN-101 attenuated GC-induced changes in duodenal histology as measured by the Vh:Cd ratio.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Baseline and Day 29
Results posted on
2025-12-18
Participant Flow
A total of 55 participants were enrolled and treated, of which 50 participants completed the study, 2 participants discontinued from the treatment phase, and 3 participants discontinued from the observation phase.
Participant milestones
| Measure |
0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7
KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion
|
Placebo
All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7
Placebo: Placebo Intravenous (IV) Infusion
|
|---|---|---|
|
Treatment Phase
STARTED
|
28
|
27
|
|
Treatment Phase
COMPLETED
|
26
|
27
|
|
Treatment Phase
NOT COMPLETED
|
2
|
0
|
|
Observation Phase
STARTED
|
26
|
27
|
|
Observation Phase
COMPLETED
|
25
|
25
|
|
Observation Phase
NOT COMPLETED
|
1
|
2
|
|
Follow-Up
STARTED
|
25
|
25
|
|
Follow-Up
COMPLETED
|
25
|
25
|
|
Follow-Up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7
KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion
|
Placebo
All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7
Placebo: Placebo Intravenous (IV) Infusion
|
|---|---|---|
|
Treatment Phase
Adverse Event
|
1
|
0
|
|
Treatment Phase
Withdrawal by Subject
|
1
|
0
|
|
Observation Phase
Adverse Event
|
1
|
1
|
|
Observation Phase
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease
Baseline characteristics by cohort
| Measure |
0.6 mg/kg KAN-101
n=28 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7
KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion
|
Placebo
n=27 Participants
All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7
Placebo: Placebo Intravenous (IV) Infusion
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.9 years
STANDARD_DEVIATION 15.10 • n=47 Participants
|
39.7 years
STANDARD_DEVIATION 13.96 • n=41 Participants
|
39.3 years
STANDARD_DEVIATION 14.42 • n=88 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=47 Participants
|
25 Participants
n=41 Participants
|
46 Participants
n=88 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=47 Participants
|
2 Participants
n=41 Participants
|
9 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=47 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=47 Participants
|
24 Participants
n=41 Participants
|
52 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=47 Participants
|
27 Participants
n=41 Participants
|
55 Participants
n=88 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
|
Height
|
167.76 cm
STANDARD_DEVIATION 9.055 • n=47 Participants
|
165.64 cm
STANDARD_DEVIATION 8.635 • n=41 Participants
|
166.72 cm
STANDARD_DEVIATION 8.834 • n=88 Participants
|
|
Weight
|
71.30 kg
STANDARD_DEVIATION 16.183 • n=47 Participants
|
71.23 kg
STANDARD_DEVIATION 13.386 • n=41 Participants
|
71.26 kg
STANDARD_DEVIATION 14.738 • n=88 Participants
|
|
Body Mass Index
|
25.30 kg/m2
STANDARD_DEVIATION 5.290 • n=47 Participants
|
26.07 kg/m2
STANDARD_DEVIATION 5.191 • n=41 Participants
|
25.68 kg/m2
STANDARD_DEVIATION 5.207 • n=88 Participants
|
|
Time since First CeD Diagnosis
|
7.8 years
STANDARD_DEVIATION 5.36 • n=47 Participants
|
9.4 years
STANDARD_DEVIATION 5.57 • n=41 Participants
|
8.6 years
STANDARD_DEVIATION 5.48 • n=88 Participants
|
|
Time on Gluten-Free Diet (GFD)
|
7.4 years
STANDARD_DEVIATION 5.34 • n=47 Participants
|
7.5 years
STANDARD_DEVIATION 5.66 • n=41 Participants
|
7.5 years
STANDARD_DEVIATION 5.45 • n=88 Participants
|
|
Human Leukocyte Antigen (HLA) Genotype
Positive
|
27 participants
n=47 Participants
|
27 participants
n=41 Participants
|
54 participants
n=88 Participants
|
|
Human Leukocyte Antigen (HLA) Genotype
Negative
|
1 participants
n=47 Participants
|
0 participants
n=41 Participants
|
1 participants
n=88 Participants
|
|
Positive Celiac Serology at Diagnosis
TISSUE TRANSGLUTAMINASE IGA ANTIBODY (TTG-IGA)
|
26 participants
n=47 Participants
|
25 participants
n=41 Participants
|
51 participants
n=88 Participants
|
|
Positive Celiac Serology at Diagnosis
TISSUE TRANSGLUTAMINASE IGG ANTIBODY (TTG-IGG)
|
5 participants
n=47 Participants
|
1 participants
n=41 Participants
|
6 participants
n=88 Participants
|
|
Positive Celiac Serology at Diagnosis
DEAMIDATED GLIADIN PEPTIDE IGA (DGP-IGA)
|
3 participants
n=47 Participants
|
0 participants
n=41 Participants
|
3 participants
n=88 Participants
|
|
Positive Celiac Serology at Diagnosis
DEAMIDATED GLIADIN PEPTIDE IGG (DGP-IGG)
|
4 participants
n=47 Participants
|
1 participants
n=41 Participants
|
5 participants
n=88 Participants
|
|
Positive Histology at Diagnosis
EVIDENCE OF VILLOUS ATROPHY (NO MARSH SCORE REPORTED)
|
18 participants
n=47 Participants
|
16 participants
n=41 Participants
|
34 participants
n=88 Participants
|
|
Positive Histology at Diagnosis
MARSH SCORE 2
|
0 participants
n=47 Participants
|
3 participants
n=41 Participants
|
3 participants
n=88 Participants
|
|
Positive Histology at Diagnosis
MARSH SCORE 3A
|
4 participants
n=47 Participants
|
1 participants
n=41 Participants
|
5 participants
n=88 Participants
|
|
Positive Histology at Diagnosis
MARSH SCORE 3B
|
3 participants
n=47 Participants
|
5 participants
n=41 Participants
|
8 participants
n=88 Participants
|
|
Positive Histology at Diagnosis
MARSH SCORE 3C
|
3 participants
n=47 Participants
|
2 participants
n=41 Participants
|
5 participants
n=88 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 29Population: Full Analysis Set - All participants who were randomly assigned to the study intervention, received all 3 doses of the study intervention, and completed at least 7 days of the 2-week GC without prohibited medications. Participants were analyzed according to the study intervention they were randomized.
KAN-101 attenuated GC-induced changes in duodenal histology as measured by the Vh:Cd ratio.
Outcome measures
| Measure |
0.6 mg/kg KAN-101
n=25 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7
KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion
|
Placebo
n=25 Participants
All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7
Placebo: Placebo Intravenous (IV) Infusion
|
|---|---|---|
|
Changes From Baseline in Villous Height to Crypt Depth (Vh:Cd) as Assessed by Esophagogastroduodenoscopy With Biopsy After 2-week Gluten Challenge (GC)
|
-0.85 ratio
Standard Deviation 0.707
|
-0.61 ratio
Standard Deviation 0.614
|
SECONDARY outcome
Timeframe: From Day 15 pre-GC to Day 15 post GCPopulation: Biomarker Analysis Set - All participants who were randomly assigned to the study intervention, received any portion of the study intervention, and had completed the GC on Day 15 without prohibited medications. Participants were analyzed according to the study intervention they were randomized.
Outcome measures
| Measure |
0.6 mg/kg KAN-101
n=26 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7
KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion
|
Placebo
n=27 Participants
All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7
Placebo: Placebo Intravenous (IV) Infusion
|
|---|---|---|
|
Change in Magnitude of Interleukin-2 (IL-2) Response From Day 15 (First Day of GC) Pre-GC to Day 15 Post GC
|
31.8 international unit
Standard Deviation 95.86
|
31.1 international unit
Standard Deviation 102.30
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: Full Analysis Set - All participants who were randomly assigned to the study intervention, received all 3 doses of the study intervention, and completed at least 7 days of the 2-week GC without prohibited medications. Participants were analyzed according to the study intervention they were randomized.
Outcome measures
| Measure |
0.6 mg/kg KAN-101
n=25 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7
KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion
|
Placebo
n=25 Participants
All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7
Placebo: Placebo Intravenous (IV) Infusion
|
|---|---|---|
|
Changes From Baseline in Intraepithelial Lymphocyte (IEL) Density in Duodenum Biopsy After 2-week GC
|
20.68 cells per 100 epithelial cells
Standard Deviation 17.447
|
17.36 cells per 100 epithelial cells
Standard Deviation 16.286
|
SECONDARY outcome
Timeframe: From the time the participant provided informed consent through Day 42.Population: Safety Analysis Set - All participants who received any portion of the study intervention. Participants were analyzed according to the study intervention they actually received.
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events. SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. According to NCI CTCAE version 5: Grade 1= mild AE; Grade 2= moderate AE; Grade 3=severe AE; Grade 4= life-threatening consequences and urgent intervention indicated; Grade 5= death related to AE. An AE was considered treatment-emergent relative to a given treatment if the event start date is during the on-treatment period (including on the date of first dose).
Outcome measures
| Measure |
0.6 mg/kg KAN-101
n=28 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7
KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion
|
Placebo
n=27 Participants
All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7
Placebo: Placebo Intravenous (IV) Infusion
|
|---|---|---|
|
Incidence and Severity of Treatment Emergent Adverse Events (TEAE) as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
Grade 3 or higher TEAE
|
1 Participants
|
0 Participants
|
|
Incidence and Severity of Treatment Emergent Adverse Events (TEAE) as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
TEAE
|
25 Participants
|
22 Participants
|
|
Incidence and Severity of Treatment Emergent Adverse Events (TEAE) as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
SAE
|
1 Participants
|
0 Participants
|
|
Incidence and Severity of Treatment Emergent Adverse Events (TEAE) as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
Grade 2 TEAE
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 42 daysPopulation: Safety analysis set - all participants who received any portion of study intervention. Participants with at least 1 positive response post-treatment.
Outcome measures
| Measure |
0.6 mg/kg KAN-101
n=28 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7
KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion
|
Placebo
All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7
Placebo: Placebo Intravenous (IV) Infusion
|
|---|---|---|
|
Incidence by Visit of KAN-101 Antidrug Antibody (ADA)
Baseline
|
0 participants
|
—
|
|
Incidence by Visit of KAN-101 Antidrug Antibody (ADA)
Day 7
|
0 participants
|
—
|
|
Incidence by Visit of KAN-101 Antidrug Antibody (ADA)
Day 29
|
3 participants
|
—
|
|
Incidence by Visit of KAN-101 Antidrug Antibody (ADA)
Day 42
|
5 participants
|
—
|
SECONDARY outcome
Timeframe: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7Population: AUC could not be determined due to limited data points. Samples at the terminal elimination phase were below limit of quantification.
Area under the plasma-concentration time curve from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
0.6 mg/kg KAN-101
n=28 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7
KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion
|
Placebo
All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7
Placebo: Placebo Intravenous (IV) Infusion
|
|---|---|---|
|
KAN-101 Plasma Concentration: AUCinf
|
NA hr/mL
AUC could not be determined due to limited data points. Samples at the terminal elimination phase were below limit of quantification.
|
—
|
SECONDARY outcome
Timeframe: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7Population: AUC could not be determined due to limited data points. Samples at the terminal elimination phase were below limit of quantification.
Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast).
Outcome measures
| Measure |
0.6 mg/kg KAN-101
n=28 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7
KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion
|
Placebo
All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7
Placebo: Placebo Intravenous (IV) Infusion
|
|---|---|---|
|
KAN-101 Plasma Concentration: AUClast
|
NA hr/mL
AUC could not be determined due to limited data points. Samples at the terminal elimination phase were below limit of quantification.
|
—
|
SECONDARY outcome
Timeframe: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7Population: PK Analysis Set - All participants who receive any portion of study intervention and have at least one post-dose concentration value.
Maximum plasma concentration.
Outcome measures
| Measure |
0.6 mg/kg KAN-101
n=28 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7
KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion
|
Placebo
All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7
Placebo: Placebo Intravenous (IV) Infusion
|
|---|---|---|
|
KAN-101 Plasma Concentration: Cmax
Day 1
|
3141.9 ng/mL
Geometric Coefficient of Variation 39
|
—
|
|
KAN-101 Plasma Concentration: Cmax
Day 7
|
4107.9 ng/mL
Geometric Coefficient of Variation 66.7
|
—
|
SECONDARY outcome
Timeframe: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7Population: PK Analysis Set - All participants who receive any portion of study intervention and have at least one post-dose concentration value.
Time to reach Cmax.
Outcome measures
| Measure |
0.6 mg/kg KAN-101
n=28 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7
KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion
|
Placebo
All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7
Placebo: Placebo Intravenous (IV) Infusion
|
|---|---|---|
|
KAN-101 Plasma Concentration: Tmax
Day 1
|
0.7 h
Standard Deviation 0.48
|
—
|
|
KAN-101 Plasma Concentration: Tmax
Day 7
|
0.6 h
Standard Deviation 0.13
|
—
|
SECONDARY outcome
Timeframe: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7Population: T1/2 could not be determined due to limited data points. Samples at the terminal elimination phase were below limit of quantification.
Terminal phase half-life.
Outcome measures
| Measure |
0.6 mg/kg KAN-101
n=28 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7
KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion
|
Placebo
All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7
Placebo: Placebo Intravenous (IV) Infusion
|
|---|---|---|
|
KAN-101 Plasma Concentration: T1/2
|
NA hour
T1/2 could not be determined due to limited data points. Samples at the terminal elimination phase were below limit of quantification.
|
—
|
Adverse Events
0.6 mg/kg KAN-101
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.6 mg/kg KAN-101
n=28 participants at risk
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7
KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion
|
Placebo
n=27 participants at risk
All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7
Placebo: Placebo Intravenous (IV) Infusion
|
|---|---|---|
|
Surgical and medical procedures
Fracture treatment
|
3.6%
1/28 • From the time the participant provided informed consent through Day 42.
|
0.00%
0/27 • From the time the participant provided informed consent through Day 42.
|
Other adverse events
| Measure |
0.6 mg/kg KAN-101
n=28 participants at risk
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7
KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion
|
Placebo
n=27 participants at risk
All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7
Placebo: Placebo Intravenous (IV) Infusion
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
14.3%
4/28 • From the time the participant provided informed consent through Day 42.
|
0.00%
0/27 • From the time the participant provided informed consent through Day 42.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/28 • From the time the participant provided informed consent through Day 42.
|
7.4%
2/27 • From the time the participant provided informed consent through Day 42.
|
|
Gastrointestinal disorders
Nausea
|
57.1%
16/28 • From the time the participant provided informed consent through Day 42.
|
40.7%
11/27 • From the time the participant provided informed consent through Day 42.
|
|
Gastrointestinal disorders
Vomiting
|
32.1%
9/28 • From the time the participant provided informed consent through Day 42.
|
14.8%
4/27 • From the time the participant provided informed consent through Day 42.
|
|
General disorders
Fatigue
|
28.6%
8/28 • From the time the participant provided informed consent through Day 42.
|
22.2%
6/27 • From the time the participant provided informed consent through Day 42.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
2/28 • From the time the participant provided informed consent through Day 42.
|
0.00%
0/27 • From the time the participant provided informed consent through Day 42.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.7%
3/28 • From the time the participant provided informed consent through Day 42.
|
0.00%
0/27 • From the time the participant provided informed consent through Day 42.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.7%
3/28 • From the time the participant provided informed consent through Day 42.
|
3.7%
1/27 • From the time the participant provided informed consent through Day 42.
|
|
Nervous system disorders
Brain fog
|
7.1%
2/28 • From the time the participant provided informed consent through Day 42.
|
0.00%
0/27 • From the time the participant provided informed consent through Day 42.
|
|
Nervous system disorders
Dizziness
|
10.7%
3/28 • From the time the participant provided informed consent through Day 42.
|
11.1%
3/27 • From the time the participant provided informed consent through Day 42.
|
|
Nervous system disorders
Headache
|
21.4%
6/28 • From the time the participant provided informed consent through Day 42.
|
25.9%
7/27 • From the time the participant provided informed consent through Day 42.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.1%
2/28 • From the time the participant provided informed consent through Day 42.
|
0.00%
0/27 • From the time the participant provided informed consent through Day 42.
|
|
Gastrointestinal disorders
Diarrhoea
|
35.7%
10/28 • From the time the participant provided informed consent through Day 42.
|
33.3%
9/27 • From the time the participant provided informed consent through Day 42.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
4/28 • From the time the participant provided informed consent through Day 42.
|
0.00%
0/27 • From the time the participant provided informed consent through Day 42.
|
|
Gastrointestinal disorders
Eructation
|
10.7%
3/28 • From the time the participant provided informed consent through Day 42.
|
0.00%
0/27 • From the time the participant provided informed consent through Day 42.
|
|
Gastrointestinal disorders
Flatulence
|
10.7%
3/28 • From the time the participant provided informed consent through Day 42.
|
7.4%
2/27 • From the time the participant provided informed consent through Day 42.
|
|
Ear and labyrinth disorders
Vertigo
|
14.3%
4/28 • From the time the participant provided informed consent through Day 42.
|
0.00%
0/27 • From the time the participant provided informed consent through Day 42.
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
7/28 • From the time the participant provided informed consent through Day 42.
|
29.6%
8/27 • From the time the participant provided informed consent through Day 42.
|
|
Gastrointestinal disorders
Abdominal pain
|
39.3%
11/28 • From the time the participant provided informed consent through Day 42.
|
25.9%
7/27 • From the time the participant provided informed consent through Day 42.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
21.4%
6/28 • From the time the participant provided informed consent through Day 42.
|
7.4%
2/27 • From the time the participant provided informed consent through Day 42.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
2/28 • From the time the participant provided informed consent through Day 42.
|
7.4%
2/27 • From the time the participant provided informed consent through Day 42.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER