Trial Outcomes & Findings for A Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 (RG6042) in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's Disease (NCT NCT04000594)
NCT ID: NCT04000594
Last Updated: 2024-10-03
Results Overview
NA represents: insufficient number of participants with events.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Day 1, 2, 3, 4, 29, 43, 71, 127, and follow-up visit (6 months after last study drug administration)
Results posted on
2024-10-03
Participant Flow
Participant milestones
| Measure |
Dose Level 1 of RO7234292 (RG6042)
Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 2 of RO7234292 (RG6042)
Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 3 of RO7234292 (RG6042)
Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dose Level 1 of RO7234292 (RG6042)
Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 2 of RO7234292 (RG6042)
Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 3 of RO7234292 (RG6042)
Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 (RG6042) in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's Disease
Baseline characteristics by cohort
| Measure |
Dose Level 1 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 2 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 3 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.3 Years
STANDARD_DEVIATION 12.2 • n=99 Participants
|
45.8 Years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
53.8 Years
STANDARD_DEVIATION 6.9 • n=206 Participants
|
47.3 Years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 1, 2, 3, 4, 29, 43, 71, 127, and follow-up visit (6 months after last study drug administration)Population: PK Population
NA represents: insufficient number of participants with events.
Outcome measures
| Measure |
Dose Level 1 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 2 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 3 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
|---|---|---|---|
|
Concentrations of RO7234292 in CSF (Cerebrospinal Fluid)
Day 1 2 hour
|
197000 ng/mL
Standard Deviation 71400
|
372000 ng/mL
Standard Deviation 132000
|
933000 ng/mL
Standard Deviation 349000
|
|
Concentrations of RO7234292 in CSF (Cerebrospinal Fluid)
Day 2 24 hour
|
6220 ng/mL
Standard Deviation 6270
|
30200 ng/mL
Standard Deviation 17300
|
41100 ng/mL
Standard Deviation 20000
|
|
Concentrations of RO7234292 in CSF (Cerebrospinal Fluid)
Day 3 48 hour
|
888 ng/mL
Standard Deviation 1510
|
4540 ng/mL
Standard Deviation 3510
|
6880 ng/mL
Standard Deviation 4830
|
|
Concentrations of RO7234292 in CSF (Cerebrospinal Fluid)
Day 4 72 hour
|
—
|
NA ng/mL
Standard Deviation NA
insufficient number of patients with available measures
|
1270 ng/mL
Standard Deviation 1070
|
|
Concentrations of RO7234292 in CSF (Cerebrospinal Fluid)
Day 29
|
1.08 ng/mL
Standard Deviation 0.773
|
1.51 ng/mL
Standard Deviation 0.757
|
2.64 ng/mL
Standard Deviation 0.572
|
|
Concentrations of RO7234292 in CSF (Cerebrospinal Fluid)
Day 43
|
2.81 ng/mL
Standard Deviation 0.906
|
3.97 ng/mL
Standard Deviation 1.85
|
6.79 ng/mL
Standard Deviation 1.15
|
|
Concentrations of RO7234292 in CSF (Cerebrospinal Fluid)
Day 71
|
1.08 ng/mL
Standard Deviation 0.459
|
1.78 ng/mL
Standard Deviation 0.0919
|
2.92 ng/mL
Standard Deviation 0.570
|
|
Concentrations of RO7234292 in CSF (Cerebrospinal Fluid)
Day 127
|
0.329 ng/mL
Standard Deviation 0.129
|
0.416 ng/mL
Standard Deviation 0.0361
|
NA ng/mL
Standard Deviation NA
insufficient number of patients with available measures
|
|
Concentrations of RO7234292 in CSF (Cerebrospinal Fluid)
Follow-up
|
NA ng/mL
Standard Deviation NA
insufficient number of patients with available measures
|
NA ng/mL
Standard Deviation NA
insufficient number of patients with available measures
|
—
|
PRIMARY outcome
Timeframe: Day 1, 2, 3, 4, 5, 28, 29, 30, 43, 71, 127, and follow-up visit (6 months after last study drug administration)Population: PK Population
NA represents:insufficient number of participants with events
Outcome measures
| Measure |
Dose Level 1 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 2 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 3 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
|---|---|---|---|
|
Concentrations of RO7234292 in Plasma
Day 71
|
NA ng/mL
Standard Deviation NA
insufficient number of patients with available measures
|
NA ng/mL
Standard Deviation NA
insufficient number of patients with available measures
|
0.983 ng/mL
Standard Deviation 0.401
|
|
Concentrations of RO7234292 in Plasma
Day 127
|
—
|
NA ng/mL
insufficient number of patients with available measures
|
—
|
|
Concentrations of RO7234292 in Plasma
Day 1 1 hour
|
209 ng/mL
Standard Deviation 173
|
709 ng/mL
Standard Deviation 765
|
941 ng/mL
Standard Deviation 625
|
|
Concentrations of RO7234292 in Plasma
Day 2 24 hour
|
30.5 ng/mL
Standard Deviation 31.1
|
709 ng/mL
Standard Deviation 765
|
104 ng/mL
Standard Deviation 84.6
|
|
Concentrations of RO7234292 in Plasma
Day 3 48 hour
|
2.66 ng/mL
Standard Deviation 4.05
|
5.87 ng/mL
Standard Deviation 5.36
|
12.8 ng/mL
Standard Deviation 5.73
|
|
Concentrations of RO7234292 in Plasma
Day 4 72 hour
|
0.480 ng/mL
Standard Deviation 0.192
|
1.76 ng/mL
Standard Deviation 1.25
|
4.20 ng/mL
Standard Deviation 2.11
|
|
Concentrations of RO7234292 in Plasma
Day 28
|
NA ng/mL
Standard Deviation NA
insufficient number of patients with available measures
|
0.119 ng/mL
Standard Deviation 0.0273
|
0.316 ng/mL
Standard Deviation 0.114
|
|
Concentrations of RO7234292 in Plasma
Day 29
|
0.142 ng/mL
Standard Deviation 0.143
|
0.135 ng/mL
Standard Deviation 0.132
|
0.292 ng/mL
Standard Deviation 0.0887
|
|
Concentrations of RO7234292 in Plasma
Day 30
|
46.4 ng/mL
Standard Deviation 27.1
|
103 ng/mL
Standard Deviation 52.0
|
317 ng/mL
Standard Deviation 57.6
|
|
Concentrations of RO7234292 in Plasma
Day 43
|
0.249 ng/mL
Standard Deviation 0.140
|
0.356 ng/mL
Standard Deviation 0.195
|
0.983 ng/mL
Standard Deviation 0.401
|
PRIMARY outcome
Timeframe: Days 1, 2, 3, 29, 43, 71, 127 and follow-up visit (6 months after last study drug administration)Population: PK Population
CSF Mutant Huntingtin Protein (fmol/L) values at time point visits are reported.
Outcome measures
| Measure |
Dose Level 1 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 2 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 3 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
|---|---|---|---|
|
mHTT (Mutant Huntingtin) Concentration in CSF
Day 1 4H
|
177.78 fmol/L
Standard Deviation 92.81
|
130.35 fmol/L
Standard Deviation 40.16
|
99.02 fmol/L
Standard Deviation 50.65
|
|
mHTT (Mutant Huntingtin) Concentration in CSF
Day 2 24H
|
204.39 fmol/L
Standard Deviation 180.26
|
81.74 fmol/L
Standard Deviation 22.38
|
127.39 fmol/L
Standard Deviation 42.40
|
|
mHTT (Mutant Huntingtin) Concentration in CSF
Day 3 48H
|
325.18 fmol/L
Standard Deviation 215.71
|
190.85 fmol/L
Standard Deviation 161.19
|
176.59 fmol/L
Standard Deviation 125.52
|
|
mHTT (Mutant Huntingtin) Concentration in CSF
Day 29 Pre-dose
|
107.46 fmol/L
Standard Deviation 85.36
|
91.53 fmol/L
Standard Deviation 20.65
|
55.62 fmol/L
Standard Deviation 16.70
|
|
mHTT (Mutant Huntingtin) Concentration in CSF
Day 43
|
83.75 fmol/L
Standard Deviation 41.84
|
66.07 fmol/L
Standard Deviation 1.08
|
68.92 fmol/L
Standard Deviation 21.89
|
|
mHTT (Mutant Huntingtin) Concentration in CSF
Day 71
|
138.25 fmol/L
Standard Deviation 127.63
|
74.86 fmol/L
Standard Deviation 14.38
|
49.24 fmol/L
Standard Deviation 12.50
|
|
mHTT (Mutant Huntingtin) Concentration in CSF
Day 127
|
127.80 fmol/L
Standard Deviation 112.79
|
81.05 fmol/L
Standard Deviation 21.84
|
41.55 fmol/L
Standard Deviation 10.96
|
|
mHTT (Mutant Huntingtin) Concentration in CSF
Follow-Up
|
132.13 fmol/L
Standard Deviation 115.59
|
68.77 fmol/L
Standard Deviation 24.49
|
61.55 fmol/L
Standard Deviation 8.84
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Safety Population
Severity levels levels: 1 = mild; 2 = moderate; 3 = severe used according to NCI-CTCAE grading system. Percentage of participants with 1-3 levels of severities are reported.
Outcome measures
| Measure |
Dose Level 1 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 2 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 3 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Any Adverse Events Level 1
|
50 Percentage of Participants
|
0 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Any Adverse Events Level 2
|
25 Percentage of Participants
|
75 Percentage of Participants
|
25.0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Any Adverse Events Level 3
|
25 Percentage of Participants
|
25 Percentage of Participants
|
25.0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Injury, poisoning and procedural complications Level 3
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Musculoskeletal and connective tissue disorders Level 1
|
75 Percentage of Participants
|
50 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Nervous system disorders Level 2
|
0 Percentage of Participants
|
25 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Nervous system disorders Level 3
|
25 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Ear and labyrinth disorders Level 3
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Investigations Level 1
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Investigations Level 2
|
0 Percentage of Participants
|
25 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Investigations Level 3
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Metabolism and nutrition disorders Leve 1
|
0 Percentage of Participants
|
0 Percentage of Participants
|
25 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Metabolism and nutrition disorders Leve 2
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Metabolism and nutrition disorders Leve 3
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Psychiatric disorders Level 1
|
0 Percentage of Participants
|
25 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Psychiatric disorders Level 2
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Psychiatric disorders Level 3
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Reproductive system and breast disorders Level 1
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Reproductive system and breast disorders Level 2
|
25 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Skin and subcutaneous tissue disorders Level 1
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Skin and subcutaneous tissue disorders Level 2
|
0 Percentage of Participants
|
0 Percentage of Participants
|
25 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Skin and subcutaneous tissue disorders Level 3
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Injury, poisoning and procedural complications Level 1
|
50 Percentage of Participants
|
25 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Injury, poisoning and procedural complications Level 2
|
50 Percentage of Participants
|
50 Percentage of Participants
|
25 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Musculoskeletal and connective tissue disorders Level 2
|
25 Percentage of Participants
|
0 Percentage of Participants
|
25 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Musculoskeletal and connective tissue disorders Level 3
|
0 Percentage of Participants
|
25 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Nervous system disorders Level 1
|
25.0 Percentage of Participants
|
25.0 Percentage of Participants
|
75 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
General disorders and administration site conditions Level 1
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
General disorders and administration site conditions Level 2
|
25 Percentage of Participants
|
25 Percentage of Participants
|
25 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
General disorders and administration site conditions Level 3
|
0 Percentage of Participants
|
0 Percentage of Participants
|
25 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Infections and infestations Level 1
|
0 Percentage of Participants
|
0 Percentage of Participants
|
25 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Infections and infestations Level 2
|
25 Percentage of Participants
|
25 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Infections and infestations Level 3
|
0 Percentage of Participants
|
25 Percentage of Participants
|
25 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Gastrointestinal disorders Level 1
|
25 Percentage of Participants
|
0 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Gastrointestinal disorders Level 2
|
0 Percentage of Participants
|
25 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Gastrointestinal disorders Level 3
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Ear and labyrinth disorders Level 1
|
25 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Ear and labyrinth disorders Level 2
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Reproductive system and breast disorders Level 3
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Respiratory, thoracic and mediastinal disorders Level 1
|
0 Percentage of Participants
|
0 Percentage of Participants
|
25 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Respiratory, thoracic and mediastinal disorders Level 2
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Respiratory, thoracic and mediastinal disorders Level 3
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: From Screening Day Up To Follow-up Visit (6 months after the last Dosing Day-Day 127)Population: ITT
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a structured tool to assess suicidal ideation and behavior. Four constructs are measured: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Binary (yes/no) data are collected for 10 categories, and composite endpoints based on the categories are followed over time to monitor patient safety. Scores 1-10 is used, 1 being less and to 10 being severity increasing. Only one time frame was used per score category: from screening to follow-up visit.
Outcome measures
| Measure |
Dose Level 1 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 2 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 3 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
|---|---|---|---|
|
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Suicidal Ideation (score 1-5) -Wish to Be Dead
|
0 Percentage
|
25 Percentage
|
0 Percentage
|
|
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Suicidal Ideation (score 1-5) -Non-specific Active Suicidal Thoughts
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
|
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
-Active Suicidal Ideation with Any Suicidal Ideation (score 1-5) -Methods (Not Plan) without Intent
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
|
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Suicidal Ideation (score 1-5) -Intent to Act, without Plan Active Suicidal Ideation
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
|
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Suicidal Ideation (score 1-5) -Active Suicidal Ideation with Specific Plan and Intent
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
|
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Suicidal Behavior (6-10) -Preparatory Acts or Behavior
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
|
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Suicidal Behavior (6-10) -Aborted Attempt
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
|
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Suicidal Behavior (6-10) -Interrupted Attempt
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
|
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Suicidal Behavior (6-10) -Non-fatal Suicide Attempt
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
|
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Suicidal Behavior (6-10) -Completed Suicide
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
|
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Suicidal Behavior (6-10) -Self-injurious Behavior without Suicidal Intent
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
SECONDARY outcome
Timeframe: Day 1, Day 28, and follow-up visit (6 months after last study drug administration)Population: Safety Population
Percentage of participants who have negative or positive anti-drug antibody affects are reported.
Outcome measures
| Measure |
Dose Level 1 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 2 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 3 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
|---|---|---|---|
|
Incidence of Anti-Drug Antibodies (ADAs)
Baseline Day 1 Total Negative
|
100 Percentage
|
100 Percentage
|
100 Percentage
|
|
Incidence of Anti-Drug Antibodies (ADAs)
Day 28 Total Negative
|
100 Percentage
|
100 Percentage
|
100 Percentage
|
|
Incidence of Anti-Drug Antibodies (ADAs)
Follow-up Total Negative
|
100 Percentage
|
100 Percentage
|
100 Percentage
|
SECONDARY outcome
Timeframe: Day 1, Day 28, and follow-up visit (6 months after last study drug administration)Population: No data evaluable participants
The data cannot be reported and the outcome measure is not applicable as no ADA sample was positive. As no ADA, titer and subtype could not be identified
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 72 hoursPopulation: PK Population
Outcome measures
| Measure |
Dose Level 1 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 2 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
Dose Level 3 of RO7234292 (RG6042)
n=4 Participants
Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
|---|---|---|---|
|
Amount of RO7234292 in Urine Ae (Micrograms)
|
236.0 micrograms
Geometric Coefficient of Variation 78.0
|
207.0 micrograms
Geometric Coefficient of Variation 131.0
|
1650.0 micrograms
Geometric Coefficient of Variation 53.0
|
Adverse Events
30 MG RG6042
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
60 MG RG6042
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
120 MG RG6042
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
30 MG RG6042
n=4 participants at risk
Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
60 MG RG6042
n=4 participants at risk
Participants will receive dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29
|
120 MG RG6042
n=4 participants at risk
Participants will receive dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
|---|---|---|---|
|
Infections and infestations
Empyema
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
Other adverse events
| Measure |
30 MG RG6042
n=4 participants at risk
Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
60 MG RG6042
n=4 participants at risk
Participants will receive dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29
|
120 MG RG6042
n=4 participants at risk
Participants will receive dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 2 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 3 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
General disorders
Catheter site pain
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
General disorders
Fatigue
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
General disorders
Medical device site erythema
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
General disorders
Medical device site vesicles
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
General disorders
Puncture site pain
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
General disorders
Vessel puncture site pain
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
General disorders
Xerosis
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Infections and infestations
Pelvic inflammatory disease
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Injury, poisoning and procedural complications
Contusion
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
75.0%
3/4 • Number of events 3 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
50.0%
2/4 • Number of events 2 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
50.0%
2/4 • Number of events 4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
50.0%
2/4 • Number of events 4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
2/4 • Number of events 2 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 2 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 3 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
50.0%
2/4 • Number of events 2 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
75.0%
3/4 • Number of events 4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Nervous system disorders
Hypoaesthesia
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Nervous system disorders
Presyncope
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Nervous system disorders
Radicular pain
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Reproductive system and breast disorders
Uterine adhesions
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
0.00%
0/4 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
25.0%
1/4 • Number of events 1 • The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER