Trial Outcomes & Findings for Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B (NCT NCT02496897)
NCT ID: NCT02496897
Last Updated: 2025-05-22
Results Overview
Incidences of all TEAEs, IP related TEAEs, severe TEAEs, TEAEs leading to discontinuation of IP, and serious TEAEs,
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
61 participants
Primary outcome timeframe
Throughout the study to Day 85
Results posted on
2025-05-22
Participant Flow
Phase 1, randomised, double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of Vaccine FP-02.2 in hepatitis B e-antigen (HBeAg)-negative patients chronically infected with HBV aged 18 to 65 years who had been receiving entecavir or tenofovir for ≥ 2 years
Subjects who met all inclusion and no exclusion criteria and provided written informed consent were enrolled within 28 days of Screening. Approximately 10 subjects were enrolled in each of 6 treatment groups in 3 sequential cohorts
Participant milestones
| Measure |
Placebo
Placebo component administered by IM injection on Days 1, 29, and 57.
Placebo: Placebo
|
IC31® Adjuvant
IC31® Adjuvant alone administered by IM injection on Days 1, 29, and 57.
IC31® Adjuvant: IC31® Adjuvant
|
FP-02.2 Low Dose
A low dose (150 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57.
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
|
FP-02.2 Low Dose With IC31® Adjuvant
A low dose (150 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57.
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
IC31® Adjuvant: IC31® Adjuvant
|
FP-02.2 High Dose
A high dose (500 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57.
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
|
FP-02.2 High Dose With IC31® Adjuvant
A high dose (500 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57.
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
IC31® Adjuvant: IC31® Adjuvant
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
10
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Placebo component administered by IM injection on Days 1, 29, and 57
Placebo: Placebo
|
IC31® Adjuvant
n=10 Participants
IC31® Adjuvant alone administered by IM injection on Days 1, 29, and 57
IC31® Adjuvant: IC31® Adjuvant
|
FP-02.2 Low Dose
n=10 Participants
A low dose (150 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
|
FP-02.2 Low Dose With IC31® Adjuvant
n=10 Participants
A low dose (150 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
IC31® Adjuvant: IC31® Adjuvant
|
FP-02.2 High Dose
n=10 Participants
A high dose (500 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
|
FP-02.2 High Dose With IC31® Adjuvant
n=11 Participants
A high dose (500 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
IC31® Adjuvant: IC31® Adjuvant
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 9.62 • n=93 Participants
|
50.9 years
STANDARD_DEVIATION 7.61 • n=4 Participants
|
41.5 years
STANDARD_DEVIATION 6.75 • n=27 Participants
|
50.0 years
STANDARD_DEVIATION 7.63 • n=483 Participants
|
47.6 years
STANDARD_DEVIATION 6.96 • n=36 Participants
|
48.9 years
STANDARD_DEVIATION 9.80 • n=10 Participants
|
47.8 years
STANDARD_DEVIATION 8.41 • n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
48 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
10 Participants
n=10 Participants
|
60 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
South Korea
|
2 participants
n=93 Participants
|
8 participants
n=4 Participants
|
0 participants
n=27 Participants
|
5 participants
n=483 Participants
|
4 participants
n=36 Participants
|
11 participants
n=10 Participants
|
30 participants
n=115 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=93 Participants
|
2 participants
n=4 Participants
|
10 participants
n=27 Participants
|
5 participants
n=483 Participants
|
6 participants
n=36 Participants
|
0 participants
n=10 Participants
|
31 participants
n=115 Participants
|
|
Race
White
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Race
Asian
|
3 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
11 Participants
n=10 Participants
|
42 Participants
n=115 Participants
|
|
Race
Other
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race
Multiple
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Body Mass Index
|
27.1 kg/m^2
STANDARD_DEVIATION 4.87 • n=93 Participants
|
24.6 kg/m^2
STANDARD_DEVIATION 3.91 • n=4 Participants
|
26.6 kg/m^2
STANDARD_DEVIATION 3.35 • n=27 Participants
|
26.8 kg/m^2
STANDARD_DEVIATION 3.48 • n=483 Participants
|
26.6 kg/m^2
STANDARD_DEVIATION 3.89 • n=36 Participants
|
23.7 kg/m^2
STANDARD_DEVIATION 1.99 • n=10 Participants
|
25.9 kg/m^2
STANDARD_DEVIATION 3.73 • n=115 Participants
|
|
Liver stiffness by Fibroscan
|
5.8 kPa
STANDARD_DEVIATION 1.32 • n=93 Participants
|
4.2 kPa
STANDARD_DEVIATION 1.24 • n=4 Participants
|
4.9 kPa
STANDARD_DEVIATION 1.41 • n=27 Participants
|
5.4 kPa
STANDARD_DEVIATION 1.34 • n=483 Participants
|
6.1 kPa
STANDARD_DEVIATION 2.25 • n=36 Participants
|
4.6 kPa
STANDARD_DEVIATION 1.06 • n=10 Participants
|
5.2 kPa
STANDARD_DEVIATION 1.57 • n=115 Participants
|
PRIMARY outcome
Timeframe: Throughout the study to Day 85Population: Safety population (all subjects who received IP)
Incidences of all TEAEs, IP related TEAEs, severe TEAEs, TEAEs leading to discontinuation of IP, and serious TEAEs,
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo component administered by IM injection on Days 1, 29, and 57
Placebo: Placebo
|
IC31® Adjuvant
n=10 Participants
IC31® Adjuvant alone administered by IM injection on Days 1, 29, and 57
IC31® Adjuvant: IC31® Adjuvant
|
FP-02.2 Low Dose
n=10 Participants
A low dose (150 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57.
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
|
FP-02.2 Low Dose With IC31® Adjuvant
n=10 Participants
A low dose (150 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
IC31® Adjuvant: IC31® Adjuvant
|
FP-02.2 High Dose
n=10 Participants
A high dose (500 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
|
FP-02.2 High Dose With IC31® Adjuvant
n=11 Participants
A high dose (500 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
IC31® Adjuvant: IC31® Adjuvant
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Any treatment emergent adverse event (TEAE)
|
9 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Possibly treatment related TEAE
|
3 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Severe TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
TEAE leading to IP discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Serious adverse event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Days 1 through 64Population: Safety population (all subjects who received IP)
Incidence of local injection site reactions occurring up to 7 days after each injection
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo component administered by IM injection on Days 1, 29, and 57
Placebo: Placebo
|
IC31® Adjuvant
n=10 Participants
IC31® Adjuvant alone administered by IM injection on Days 1, 29, and 57
IC31® Adjuvant: IC31® Adjuvant
|
FP-02.2 Low Dose
n=10 Participants
A low dose (150 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57.
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
|
FP-02.2 Low Dose With IC31® Adjuvant
n=10 Participants
A low dose (150 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
IC31® Adjuvant: IC31® Adjuvant
|
FP-02.2 High Dose
n=10 Participants
A high dose (500 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
|
FP-02.2 High Dose With IC31® Adjuvant
n=11 Participants
A high dose (500 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
IC31® Adjuvant: IC31® Adjuvant
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Local Injection Site Reactions
Any injection site reaction
|
2 Participants
|
1 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Local Injection Site Reactions
Burning sensation
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Local Injection Site Reactions
Erythema/redness
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Local Injection Site Reactions
Induration/hardening
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Local Injection Site Reactions
Pain (without pressure)
|
1 Participants
|
0 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Local Injection Site Reactions
Pain/tenderness (on pressure)
|
2 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Local Injection Site Reactions
Swelling
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Local Injection Site Reactions
Wheal(s)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Change from baseline to Day 85IFN-gamma ELISpot assay specific for FP-02.2 peptides using cryopreserved PBMCs
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo component administered by IM injection on Days 1, 29, and 57
Placebo: Placebo
|
IC31® Adjuvant
n=6 Participants
IC31® Adjuvant alone administered by IM injection on Days 1, 29, and 57
IC31® Adjuvant: IC31® Adjuvant
|
FP-02.2 Low Dose
n=5 Participants
A low dose (150 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57.
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
|
FP-02.2 Low Dose With IC31® Adjuvant
n=7 Participants
A low dose (150 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
IC31® Adjuvant: IC31® Adjuvant
|
FP-02.2 High Dose
n=9 Participants
A high dose (500 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
|
FP-02.2 High Dose With IC31® Adjuvant
n=5 Participants
A high dose (500 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
IC31® Adjuvant: IC31® Adjuvant
|
|---|---|---|---|---|---|---|
|
Immunological Response
|
166.7 spot forming units/ 10^6 PBMC
Interval -6717.0 to 6692.0
|
1683.3 spot forming units/ 10^6 PBMC
Interval 67.0 to 17350.0
|
900 spot forming units/ 10^6 PBMC
Interval -300.0 to 4158.0
|
5608.3 spot forming units/ 10^6 PBMC
Interval 0.0 to 17483.0
|
1433.3 spot forming units/ 10^6 PBMC
Interval -7717.0 to 7833.0
|
4804.2 spot forming units/ 10^6 PBMC
Interval 293.0 to 10192.0
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
IC31® Adjuvant
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
FP-02.2 Low Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
FP-02.2 Low Dose With IC31® Adjuvant
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
FP-02.2 High Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
FP-02.2 High Dose With IC31® Adjuvant
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=10 participants at risk
Placebo component.
Placebo: Placebo
|
IC31® Adjuvant
n=10 participants at risk
IC31® Adjuvant alone.
IC31® Adjuvant: IC31® Adjuvant
|
FP-02.2 Low Dose
n=10 participants at risk
A low dose of the FP-02.2 vaccine.
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
|
FP-02.2 Low Dose With IC31® Adjuvant
n=10 participants at risk
A low dose of the FP-02.2 vaccine with IC31® Adjuvant.
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
IC31® Adjuvant: IC31® Adjuvant
|
FP-02.2 High Dose
n=10 participants at risk
A high dose of the FP-02.2 vaccine.
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
|
FP-02.2 High Dose With IC31® Adjuvant
n=11 participants at risk
A high dose of the FP-02.2 vaccine with IC31® Adjuvant.
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
IC31® Adjuvant: IC31® Adjuvant
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Moderate infectious colitis
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
9.1%
1/11 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Placebo component.
Placebo: Placebo
|
IC31® Adjuvant
n=10 participants at risk
IC31® Adjuvant alone.
IC31® Adjuvant: IC31® Adjuvant
|
FP-02.2 Low Dose
n=10 participants at risk
A low dose of the FP-02.2 vaccine.
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
|
FP-02.2 Low Dose With IC31® Adjuvant
n=10 participants at risk
A low dose of the FP-02.2 vaccine with IC31® Adjuvant.
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
IC31® Adjuvant: IC31® Adjuvant
|
FP-02.2 High Dose
n=10 participants at risk
A high dose of the FP-02.2 vaccine.
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
|
FP-02.2 High Dose With IC31® Adjuvant
n=11 participants at risk
A high dose of the FP-02.2 vaccine with IC31® Adjuvant.
FP-02.2 Vaccine: Synthetic Peptide Hepatitis B Vaccine
IC31® Adjuvant: IC31® Adjuvant
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Nervous System disorders
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
30.0%
3/10 • Number of events 4 • Throughout the study to day 85
Treatment emergent adverse events
|
30.0%
3/10 • Number of events 5 • Throughout the study to day 85
Treatment emergent adverse events
|
20.0%
2/10 • Number of events 3 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/11 • Throughout the study to day 85
Treatment emergent adverse events
|
|
Infections and infestations
Infections and infestations
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
40.0%
4/10 • Number of events 5 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
27.3%
3/11 • Number of events 3 • Throughout the study to day 85
Treatment emergent adverse events
|
|
General disorders
General disorders and administration site conditions
|
20.0%
2/10 • Number of events 4 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 3 • Throughout the study to day 85
Treatment emergent adverse events
|
20.0%
2/10 • Number of events 3 • Throughout the study to day 85
Treatment emergent adverse events
|
20.0%
2/10 • Number of events 5 • Throughout the study to day 85
Treatment emergent adverse events
|
18.2%
2/11 • Number of events 2 • Throughout the study to day 85
Treatment emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
20.0%
2/10 • Number of events 3 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
30.0%
3/10 • Number of events 4 • Throughout the study to day 85
Treatment emergent adverse events
|
20.0%
2/10 • Number of events 5 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 3 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/11 • Throughout the study to day 85
Treatment emergent adverse events
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
60.0%
6/10 • Number of events 9 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 2 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 2 • Throughout the study to day 85
Treatment emergent adverse events
|
20.0%
2/10 • Number of events 2 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
9.1%
1/11 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
|
Investigations
Investigations
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
20.0%
2/10 • Number of events 2 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/11 • Throughout the study to day 85
Treatment emergent adverse events
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/11 • Throughout the study to day 85
Treatment emergent adverse events
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
20.0%
2/10 • Number of events 2 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/11 • Throughout the study to day 85
Treatment emergent adverse events
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
9.1%
1/11 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/11 • Throughout the study to day 85
Treatment emergent adverse events
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/11 • Throughout the study to day 85
Treatment emergent adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/11 • Throughout the study to day 85
Treatment emergent adverse events
|
|
Vascular disorders
Vascular disorders
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/11 • Throughout the study to day 85
Treatment emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
10.0%
1/10 • Number of events 1 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/10 • Throughout the study to day 85
Treatment emergent adverse events
|
0.00%
0/11 • Throughout the study to day 85
Treatment emergent adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place