Trial Outcomes & Findings for Study to Evaluate Safety and PK of a Single IM Dose of G03-52-01 vs Placebo in Adult Subjects (NCT NCT04171115)
NCT ID: NCT04171115
Last Updated: 2024-10-04
Results Overview
Determine number of SAEs after dosing (Cohorts 1-3)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
day 0 to day 120
Results posted on
2024-10-04
Participant Flow
Participant milestones
| Measure |
10mg of G03-52-01
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
100 mg of G03-52-01
8 subjects randomized to 100 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
8
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate Safety and PK of a Single IM Dose of G03-52-01 vs Placebo in Adult Subjects
Baseline characteristics by cohort
| Measure |
10mg of G03-52-01
n=7 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 Participants
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
100 mg of G03-52-01
n=8 Participants
8 subjects randomized to 100 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
n=8 Participants
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.1 years
STANDARD_DEVIATION 9.58 • n=5 Participants
|
33.9 years
STANDARD_DEVIATION 6.69 • n=7 Participants
|
35.8 years
STANDARD_DEVIATION 6.58 • n=5 Participants
|
34 years
STANDARD_DEVIATION 4.04 • n=4 Participants
|
36.3 years
STANDARD_DEVIATION 6.98 • n=21 Participants
|
34.8 years
STANDARD_DEVIATION 6.77 • n=10 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
33 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Weight
|
75.77 kg
STANDARD_DEVIATION 16.849 • n=5 Participants
|
75.60 kg
STANDARD_DEVIATION 13.001 • n=7 Participants
|
74.59 kg
STANDARD_DEVIATION 16.828 • n=5 Participants
|
88.71 kg
STANDARD_DEVIATION 12.486 • n=4 Participants
|
87.15 kg
STANDARD_DEVIATION 8.892 • n=21 Participants
|
80.36 kg
STANDARD_DEVIATION 13.611 • n=10 Participants
|
|
Body Mass Index (kg/m2)
|
27.47 kg/m^2
STANDARD_DEVIATION 3.638 • n=5 Participants
|
27.70 kg/m^2
STANDARD_DEVIATION 4.419 • n=7 Participants
|
28.44 kg/m^2
STANDARD_DEVIATION 5.098 • n=5 Participants
|
30.06 kg/m^2
STANDARD_DEVIATION 1.907 • n=4 Participants
|
31.03 kg/m^2
STANDARD_DEVIATION 2.841 • n=21 Participants
|
28.94 kg/m^2
STANDARD_DEVIATION 3.58 • n=10 Participants
|
|
Height
|
165.39 cm
STANDARD_DEVIATION 11.347 • n=5 Participants
|
165.05 cm
STANDARD_DEVIATION 5.190 • n=7 Participants
|
161.45 cm
STANDARD_DEVIATION 9.441 • n=5 Participants
|
171.48 cm
STANDARD_DEVIATION 10.268 • n=4 Participants
|
167.86 cm
STANDARD_DEVIATION 11.281 • n=21 Participants
|
166.25 cm
STANDARD_DEVIATION 9.51 • n=10 Participants
|
PRIMARY outcome
Timeframe: day 0 to day 120Determine number of SAEs after dosing (Cohorts 1-3)
Outcome measures
| Measure |
10mg of G03-52-01
n=7 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 Participants
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
n=8 Participants
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
The Occurrence of Serious Adverse Events (SAE) Following Administration of G03-52-01 to the Final Follow-up Visit.
|
0 Number of SAEs
|
0 Number of SAEs
|
0 Number of SAEs
|
0 Number of SAEs
|
PRIMARY outcome
Timeframe: day 0 to day 180Determine number of SAEs after dosing (Cohort 4)
Outcome measures
| Measure |
10mg of G03-52-01
n=8 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
The Occurrence of Serious Adverse Events (SAE) Following Administration of G03-52-01 to the Final Follow-up Visit.
|
0 Number of SAEs
|
0 Number of SAEs
|
—
|
—
|
PRIMARY outcome
Timeframe: day 0 to day 120Determine number of AEs after dosing (Cohorts 1-3)
Outcome measures
| Measure |
10mg of G03-52-01
n=7 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 Participants
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
n=8 Participants
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
The Occurrence of Adverse Events (AE) Following Administration of G03-52-01 to the Final Follow-up Visit
|
8 Number of AEs
|
10 Number of AEs
|
11 Number of AEs
|
6 Number of AEs
|
PRIMARY outcome
Timeframe: day 0 to day 180Determine number of AEs after dosing (Cohort 4)
Outcome measures
| Measure |
10mg of G03-52-01
n=8 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
The Occurrence of Adverse Events (AE) Following Administration of G03-52-01 to the Final Follow-up Visit
|
8 Number of AEs
|
6 Number of AEs
|
—
|
—
|
PRIMARY outcome
Timeframe: day 0 to day 120Determine number of changes from baseline (Cohorts 1-3)
Outcome measures
| Measure |
10mg of G03-52-01
n=7 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 Participants
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
n=8 Participants
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
The Occurrence of Changes From Baseline in Physical Examination, Vital Signs and Clinical Safety Laboratory Values Following Administration of G03-52-01 to the Final Follow-up Visit.
|
7 Number of events
|
3 Number of events
|
7 Number of events
|
4 Number of events
|
PRIMARY outcome
Timeframe: day 0 to day 180Determine number of changes from baseline (Cohort 4)
Outcome measures
| Measure |
10mg of G03-52-01
n=8 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
The Occurrence of Changes From Baseline in Physical Examination, Vital Signs and Clinical Safety Laboratory Values Following Administration of G03-52-01 to the Final Follow-up Visit.
|
1 Number of events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, days 4, 30, 60, 90, and 120MNA assessment of PD (Cohorts 1-3)
Outcome measures
| Measure |
10mg of G03-52-01
n=7 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 Participants
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Serotype A Peak Plasma Concentration (Cmax)
|
0.0977 U/L
Geometric Coefficient of Variation 46.37
|
0.288 U/L
Geometric Coefficient of Variation 47.14
|
0.658 U/L
Geometric Coefficient of Variation 49.29
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120MNA assessment of PD (Cohort 4)
Outcome measures
| Measure |
10mg of G03-52-01
n=8 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Serotype A Peak Plasma Concentration (Cmax)
|
2.07 U/L
Geometric Coefficient of Variation 79.84
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, days 4, 30, 60, 90, and 120MNA assessment of PD (Cohorts 1-3)
Outcome measures
| Measure |
10mg of G03-52-01
n=7 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 Participants
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Serotype B Peak Plasma Concentration (Cmax)
|
0.630 U/L
Geometric Coefficient of Variation 100.37
|
1.30 U/L
Geometric Coefficient of Variation 53.38
|
2.25 U/L
Geometric Coefficient of Variation 57.90
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120MNA assessment of PD (Cohort 4)
Outcome measures
| Measure |
10mg of G03-52-01
n=8 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Serotype B Peak Plasma Concentration (Cmax)
|
3.63 U/L
Geometric Coefficient of Variation 20.85
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, days 4, 30, 60, 90, and 120MNA assessment of PD (Cohorts 1-3)
Outcome measures
| Measure |
10mg of G03-52-01
n=7 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 Participants
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Serotype A Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
|
96 hrs
Interval 96.0 to 96.0
|
95.89 hrs
Interval 95.6 to 96.98
|
96 hrs
Interval 95.42 to 97.13
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120MNA assessment of PD (Cohort 4)
Outcome measures
| Measure |
10mg of G03-52-01
n=8 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Serotype A Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
|
95.76 hrs
Interval 93.95 to 96.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, days 4, 30, 60, 90, and 120MNA assessment of PD (Cohorts 1-3)
Outcome measures
| Measure |
10mg of G03-52-01
n=7 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 Participants
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Serotype B Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
|
96 hrs
Interval 96.0 to 1394.55
|
96.78 hrs
Interval 95.77 to 1463.82
|
96.01 hrs
Interval 95.42 to 744.03
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120MNA assessment of PD (Cohort 4)
Outcome measures
| Measure |
10mg of G03-52-01
n=8 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Serotype B Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
|
95.88 hrs
Interval 93.95 to 695.88
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, days 4, 30, 60, 90, and 120MNA assessment of PD (Cohorts 1-3)
Outcome measures
| Measure |
10mg of G03-52-01
n=7 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 Participants
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Serotype A Area Under the Plasma Concentration Versus Time Curve (AUC)
|
23.530 h*U/L
Geometric Coefficient of Variation 174.61
|
82.821 h*U/L
Geometric Coefficient of Variation 189.37
|
281.393 h*U/L
Geometric Coefficient of Variation 33.21
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120MNA assessment of PD (Cohort 4)
Outcome measures
| Measure |
10mg of G03-52-01
n=8 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Serotype A Area Under the Plasma Concentration Versus Time Curve (AUC)
|
1106.673 h*U/L
Geometric Coefficient of Variation 57.81
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, days 4, 30, 60, 90, and 120MNA assessment of PD (Cohorts 1-3)
Outcome measures
| Measure |
10mg of G03-52-01
n=7 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 Participants
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Serotype B Area Under the Plasma Concentration Versus Time Curve (AUC)
|
608.306 h*U/L
Geometric Coefficient of Variation 49.6
|
1208.471 h*U/L
Geometric Coefficient of Variation 53.63
|
1939.427 h*U/L
Geometric Coefficient of Variation 40.93
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120MNA assessment of PD (Cohort 4)
Outcome measures
| Measure |
10mg of G03-52-01
n=8 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Serotype B Area Under the Plasma Concentration Versus Time Curve (AUC)
|
2940.815 h*U/L
Geometric Coefficient of Variation 33.14
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-injection, 2, 4, 8, 24, 48, and 72 hours post injection, and on days 4, 8, 15, 30, 45, 60, 90, and 120ELISA/ECLA assessment of PK (Cohorts 1-3)
Outcome measures
| Measure |
10mg of G03-52-01
n=7 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 Participants
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Anti-BoNT A Peak Plasma Concentration (Cmax)
|
123.06 ng/mL
Geometric Coefficient of Variation 17.66
|
362.845 ng/mL
Geometric Coefficient of Variation 33.605
|
678.635 ng/mL
Geometric Coefficient of Variation 44.12
|
—
|
SECONDARY outcome
Timeframe: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180ELISA/ECLA assessment of PK (Cohort 4)
Outcome measures
| Measure |
10mg of G03-52-01
n=8 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Anti-BoNT A Peak Plasma Concentration (Cmax)
|
1372.08 ng/mL
Geometric Coefficient of Variation 33.69
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180ELISA/ECLA assessment of PK (Cohort 4)
Outcome measures
| Measure |
10mg of G03-52-01
n=8 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Anti-BoNT B Peak Plasma Concentration (Cmax)
|
1668.88 ng/mL
Geometric Coefficient of Variation 26.73
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-injection, 2,4, 8, 24, 48, and 72 hours post injection, and on days 4, 8, 15, 30, 45, 60, 90, and 120ELISA/ECLA assessment of PK (Cohorts 1-3)
Outcome measures
| Measure |
10mg of G03-52-01
n=7 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 Participants
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Anti-BoNT B Peak Plasma Concentration (Cmax)
|
133.49 ng/mL
Geometric Coefficient of Variation 18.73
|
401.25 ng/mL
Geometric Coefficient of Variation 30.44
|
722.73 ng/mL
Geometric Coefficient of Variation 37.85
|
—
|
SECONDARY outcome
Timeframe: pre-injection, 2, 4, 8, 24, 48, and 72 hours post injection, and on days 4, 8, 15, 30, 45, 60, 90, and 120ELISA/ECLA assessment of PK (Cohorts 1-3)
Outcome measures
| Measure |
10mg of G03-52-01
n=7 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 Participants
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Anti-BoNT A Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
|
84 hrs
Interval 48.0 to 359.53
|
71.71 hrs
Interval 47.73 to 359.95
|
71.34 hrs
Interval 48.07 to 192.02
|
—
|
SECONDARY outcome
Timeframe: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180ELISA/ECLA assessment of PK (Cohort 4)
Outcome measures
| Measure |
10mg of G03-52-01
n=8 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Anti-BoNT A Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
|
47.87 hrs
Interval 24.18 to 96.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-injection, 2, 4, 8, 24, 48, and 72 hours post injection, and on days 4, 8, 15, 30, 45, 60, 90, and 120ELISA/ECLA assessment of PK (Cohorts 1-3)
Outcome measures
| Measure |
10mg of G03-52-01
n=7 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 Participants
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Anti-BoNT B Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
|
128 hrs
Interval 48.0 to 192.0
|
107.83 hrs
Interval 47.73 to 359.95
|
79.58 hrs
Interval 24.18 to 192.12
|
—
|
SECONDARY outcome
Timeframe: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180ELISA/ECLA assessment of PK (Cohort 4)
Outcome measures
| Measure |
10mg of G03-52-01
n=8 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Anti-BoNT B Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
|
72.59 hrs
Interval 24.18 to 192.12
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-injection, 2, 4, 8, 24, 48, and 72 hours post injection, and on days 4, 8, 15, 30, 45, 60, 90, and 120ELISA/ECLA assessment of PK (Cohorts 1-3)
Outcome measures
| Measure |
10mg of G03-52-01
n=7 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 Participants
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Anti-BoNT A Area Under the Plasma Concentration Versus Time Curve (AUC)
|
76121.9 h*ng/mL
Geometric Coefficient of Variation 32.64
|
211066.2 h*ng/mL
Geometric Coefficient of Variation 29.35
|
346965.1 h*ng/mL
Geometric Coefficient of Variation 33.76
|
—
|
SECONDARY outcome
Timeframe: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180ELISA/ECLA assessment of PK (Cohort 4)
Outcome measures
| Measure |
10mg of G03-52-01
n=8 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Anti-BoNT A Area Under the Plasma Concentration Versus Time Curve (AUC)
|
598555.3 h*ng/mL
Geometric Coefficient of Variation 77.05
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-injection, 2, 4, 8, 24, 48, and 72 hours post injection and on days 4, 8, 15, 30, 45, 60, 90, and 120ELISA/ECLA assessment of PK (Cohort 1-3)
Outcome measures
| Measure |
10mg of G03-52-01
n=7 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 Participants
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Anti-BoNT B Area Under the Plasma Concentration Versus Time Curve (AUC)
|
120541.5 h*ng/mL
Geometric Coefficient of Variation 30.55
|
338924.7 h*ng/mL
Geometric Coefficient of Variation 28.11
|
530432.5 h*ng/mL
Geometric Coefficient of Variation 29.64
|
—
|
SECONDARY outcome
Timeframe: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180ELISA/ECLA assessment of PK (Cohort 4)
Outcome measures
| Measure |
10mg of G03-52-01
n=8 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Anti-BoNT B Area Under the Plasma Concentration Versus Time Curve (AUC)
|
1259300 h*ng/mL
Geometric Coefficient of Variation 30.16
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, days 15, 30, 45, 60, 90, and 120To assess the number of participants with positive anti-drug antibody levels (Cohorts 1-3)
Outcome measures
| Measure |
10mg of G03-52-01
n=7 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 Participants
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 Participants
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Anti-drug Antibodies (ADA)
|
5 Participants
|
6 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: pre-dose, days 45, 60, 90, 120, and 180To assess the number of participants with positive anti-drug antibody levels (Cohort 4)
Outcome measures
| Measure |
10mg of G03-52-01
n=8 Participants
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|
|
Anti-drug Antibodies (ADA)
|
5 Participants
|
—
|
—
|
—
|
Adverse Events
10mg of G03-52-01
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
25mg of G03-52-01
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
50 mg of G03-52-01
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
100 mg of G03-52-01
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Pooled Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
10mg of G03-52-01
n=7 participants at risk
8 subjects randomized to 10 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
25mg of G03-52-01
n=8 participants at risk
8 subjects randomized to 25 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
50 mg of G03-52-01
n=8 participants at risk
8 subjects randomized to 50 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
100 mg of G03-52-01
n=8 participants at risk
8 subjects randomized to 100 mg of G03-52-01
G03-52-01: G03-52-01 administered intramuscularly
|
Pooled Placebo
n=8 participants at risk
2 subjects randomized to placebo in each of the 4 cohorts/dosing groups
Placebo: Placebo administered intramuscularly
|
|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
General disorders
Ill-defined disorder
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
General disorders
Injection site bruising
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
General disorders
Injection site erythema
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Infections and infestations
Viral rash
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Investigations
Blood creatine phosphokinase increased
|
28.6%
2/7 • Number of events 2 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
25.0%
2/8 • Number of events 2 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Investigations
Blood sodium increased
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
25.0%
2/8 • Number of events 2 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Investigations
Blood calcium decreased
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Investigations
Blood pressure systolic decreased
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Investigations
Neutrophil count decreased
|
14.3%
1/7 • Number of events 2 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Investigations
White blood cell count decreased
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Musculoskeletal and connective tissue disorders
Limbs stiffness
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
25.0%
2/8 • Number of events 2 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Nervous system disorders
Light headedness
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Renal and urinary disorders
Haematuria
|
14.3%
1/7 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/7 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
|
Vascular disorders
Diastolic hypertension
|
14.3%
1/7 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
12.5%
1/8 • Number of events 1 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
0.00%
0/8 • 120 days for Cohorts 1-3 and 180 days for Cohort 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place