Trial Outcomes & Findings for A Study to Evaluate the Intramuscular Administration of Scopolamine (NCT NCT04314713)
NCT ID: NCT04314713
Last Updated: 2025-02-19
Results Overview
Safety and tolerability profile of ascending doses of scopolamine hydrobromide trihydrate (Scopolamine HBT) administered by intramuscular (IM) injection
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
30 Days (+7)
Results posted on
2025-02-19
Participant Flow
Participant milestones
| Measure |
Cohort 1 Scopolamine HBT 0.005 mg/kg
IM Dose of Scopolamine 0.005mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 2 Scopolamine HBT 0.007 mg/kg
IM Dose of Scopolamine 0.007mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 3 Scopolamine HBT 0.011 mg/kg
IM Dose of Scopolamine 0.011mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 4 Scopolamine HBT 0.014 mg/kg
IM Dose of Scopolamine 0.014mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 5 Scopolamine HBT 0.021 mg/kg
IM Dose of Scopolamine 0.021mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo
Placebo controlled
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
0
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
5
|
0
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 Scopolamine HBT 0.005 mg/kg
IM Dose of Scopolamine 0.005mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 2 Scopolamine HBT 0.007 mg/kg
IM Dose of Scopolamine 0.007mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 3 Scopolamine HBT 0.011 mg/kg
IM Dose of Scopolamine 0.011mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 4 Scopolamine HBT 0.014 mg/kg
IM Dose of Scopolamine 0.014mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 5 Scopolamine HBT 0.021 mg/kg
IM Dose of Scopolamine 0.021mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo
Placebo controlled
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Intramuscular Administration of Scopolamine
Baseline characteristics by cohort
| Measure |
Cohort 1 Scopolamine HBT 0.005 mg/kg
n=6 Participants
Dose of Scopolamine 0.005mg/kg verses Placebo
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 2 Scopolamine HBT 0.007 mg/kg
n=6 Participants
Dose of Scopolamine 0.007mg/kg verses Placebo
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 3 Scopolamine HBT 0.011 mg/kg
n=6 Participants
Dose of Scopolamine 0.011mg/kg verses Placebo
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 4 Scopolamine HBT 0.014 mg/kg
n=6 Participants
Dose of Scopolamine 0.014mg/kg verses Placebo
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 5 Scopolamine HBT 0.021 mg/kg
Dose of Scopolamine 0.021mg/kg verses Placebo
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo
n=8 Participants
Placebo controlled
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
Age (years) mean
|
34.8 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
34.8 years
STANDARD_DEVIATION 9.11 • n=107 Participants
|
31.7 years
STANDARD_DEVIATION 10.31 • n=206 Participants
|
35.7 years
STANDARD_DEVIATION 11.48 • n=7 Participants
|
—
|
32.6 years
STANDARD_DEVIATION 10.07 • n=30 Participants
|
33.8 years
STANDARD_DEVIATION 9.58 • n=3 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
—
|
3 Participants
n=30 Participants
|
15 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
—
|
5 Participants
n=30 Participants
|
17 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
—
|
2 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
—
|
6 Participants
n=30 Participants
|
24 Participants
n=3 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
|
—
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
—
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=30 Participants
|
0 Participants
n=3 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
|
—
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
—
|
5 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
—
|
2 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
—
|
0 Participants
n=30 Participants
|
2 Participants
n=3 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
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
6 participants
n=206 Participants
|
6 participants
n=7 Participants
|
—
|
8 participants
n=30 Participants
|
32 participants
n=3 Participants
|
|
Body Mass Index (BMI)
|
24.55 kg/m^2
STANDARD_DEVIATION 3.454 • n=99 Participants
|
25.58 kg/m^2
STANDARD_DEVIATION 2.143 • n=107 Participants
|
24.17 kg/m^2
STANDARD_DEVIATION 1.876 • n=206 Participants
|
25.95 kg/m^2
STANDARD_DEVIATION 2.669 • n=7 Participants
|
—
|
24.58 kg/m^2
STANDARD_DEVIATION 2.232 • n=30 Participants
|
24.94 kg/m^2
STANDARD_DEVIATION 2.442 • n=3 Participants
|
PRIMARY outcome
Timeframe: 30 Days (+7)Population: On 13 June 2021, following DSMB recommendation and final sponsor decision, the PI was notified of the sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
Safety and tolerability profile of ascending doses of scopolamine hydrobromide trihydrate (Scopolamine HBT) administered by intramuscular (IM) injection
Outcome measures
| Measure |
Cohort 1 Scopolamine HBT 0.005 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.005mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 2 Scopolamine HBT 0.007 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.007mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 3 Scopolamine HBT 0.011 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.011mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 4 Scopolamine HBT 0.014 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.014mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 5 Scopolamine HBT 0.021 mg/kg
IM Dose of Scopolamine 0.021mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo
n=8 Participants
Placebo controlled
|
|---|---|---|---|---|---|---|
|
Determine Degree and Number of Adverse Events Experienced by Subjects.
Any Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Determine Degree and Number of Adverse Events Experienced by Subjects.
Any TEAEs Leading to Discontinuation of Study Drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Determine Degree and Number of Adverse Events Experienced by Subjects.
Adverse Events : Subjects with at least 1 AE
|
6 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
—
|
5 Participants
|
|
Determine Degree and Number of Adverse Events Experienced by Subjects.
Somnolence
|
2 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
—
|
1 Participants
|
|
Determine Degree and Number of Adverse Events Experienced by Subjects.
Dizziness
|
2 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
—
|
0 Participants
|
|
Determine Degree and Number of Adverse Events Experienced by Subjects.
Headache
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
0 Participants
|
|
Determine Degree and Number of Adverse Events Experienced by Subjects.
Injection site pain
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
3 Participants
|
|
Determine Degree and Number of Adverse Events Experienced by Subjects.
Injection site paraesthesia
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
2 Participants
|
|
Determine Degree and Number of Adverse Events Experienced by Subjects.
Injection site hypoaesthesia
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
2 Participants
|
|
Determine Degree and Number of Adverse Events Experienced by Subjects.
Dry mouth
|
4 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Determine Degree and Number of Adverse Events Experienced by Subjects.
Delirium
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
0 Participants
|
|
Determine Degree and Number of Adverse Events Experienced by Subjects.
Any TEAEs
|
6 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
—
|
5 Participants
|
|
Determine Degree and Number of Adverse Events Experienced by Subjects.
Any Treatment-Related Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Determine Degree and Number of Adverse Events Experienced by Subjects.
Any TEAEs Leading to Discontinuation of Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Determine Degree and Number of Adverse Events Experienced by Subjects.
Any TEAEs Leading to Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Determine Degree and Number of Adverse Events Experienced by Subjects.
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Determine Degree and Number of Adverse Events Experienced by Subjects.
DLTs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 Days (+7)Cmax of ascending doses of Scopolamine HBT administered by IM injection.
Outcome measures
| Measure |
Cohort 1 Scopolamine HBT 0.005 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.005mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 2 Scopolamine HBT 0.007 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.007mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 3 Scopolamine HBT 0.011 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.011mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 4 Scopolamine HBT 0.014 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.014mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 5 Scopolamine HBT 0.021 mg/kg
IM Dose of Scopolamine 0.021mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo
Placebo controlled
|
|---|---|---|---|---|---|---|
|
Cmax of Ascending Doses of Scopolamine HBT Administered by IM Injection.
|
0.67 Cmax (ug/mL)
Standard Deviation 0.286
|
1.07 Cmax (ug/mL)
Standard Deviation 0.529
|
1.53 Cmax (ug/mL)
Standard Deviation 0.501
|
1.91 Cmax (ug/mL)
Standard Deviation 0.455
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 Days (+7)Tmax of ascending doses of Scopolamine HBT administered by IM injection.
Outcome measures
| Measure |
Cohort 1 Scopolamine HBT 0.005 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.005mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 2 Scopolamine HBT 0.007 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.007mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 3 Scopolamine HBT 0.011 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.011mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 4 Scopolamine HBT 0.014 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.014mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 5 Scopolamine HBT 0.021 mg/kg
IM Dose of Scopolamine 0.021mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo
Placebo controlled
|
|---|---|---|---|---|---|---|
|
Tmax of Ascending Doses of Scopolamine HBT Administered by IM Injection.
|
1 Tmax (hr)
Standard Deviation 0.4
|
1 Tmax (hr)
Standard Deviation 0.8
|
1 Tmax (hr)
Standard Deviation 0.6
|
1 Tmax (hr)
Standard Deviation 0.5
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 Days (+7)Apparent Volume of Distribution (mL/kg) of ascending doses of Scopolamine HBT administered by IM injection.
Outcome measures
| Measure |
Cohort 1 Scopolamine HBT 0.005 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.005mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 2 Scopolamine HBT 0.007 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.007mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 3 Scopolamine HBT 0.011 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.011mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 4 Scopolamine HBT 0.014 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.014mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 5 Scopolamine HBT 0.021 mg/kg
IM Dose of Scopolamine 0.021mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo
Placebo controlled
|
|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (mL/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
|
6258 Apparent Volume of Distribution (mL/kg)
Standard Deviation 1678.1
|
5552 Apparent Volume of Distribution (mL/kg)
Standard Deviation 1710.3
|
5963 Apparent Volume of Distribution (mL/kg)
Standard Deviation 970.8
|
10210 Apparent Volume of Distribution (mL/kg)
Standard Deviation 4402.5
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 Days (+7)t1/2 (hr) of ascending doses of Scopolamine HBT administered by IM injection.
Outcome measures
| Measure |
Cohort 1 Scopolamine HBT 0.005 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.005mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 2 Scopolamine HBT 0.007 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.007mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 3 Scopolamine HBT 0.011 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.011mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 4 Scopolamine HBT 0.014 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.014mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 5 Scopolamine HBT 0.021 mg/kg
IM Dose of Scopolamine 0.021mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo
Placebo controlled
|
|---|---|---|---|---|---|---|
|
t1/2 (hr) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
|
1.99 t1/2 (hr)
Standard Deviation 0.235
|
1.88 t1/2 (hr)
Standard Deviation 0.207
|
2.10 t1/2 (hr)
Standard Deviation 0.535
|
4.47 t1/2 (hr)
Standard Deviation 2.876
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 Days (+7)Apparent Clearance (mL/hr/kg) of ascending doses of Scopolamine HBT administered by IM injection.
Outcome measures
| Measure |
Cohort 1 Scopolamine HBT 0.005 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.005mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 2 Scopolamine HBT 0.007 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.007mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 3 Scopolamine HBT 0.011 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.011mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 4 Scopolamine HBT 0.014 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.014mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 5 Scopolamine HBT 0.021 mg/kg
IM Dose of Scopolamine 0.021mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo
Placebo controlled
|
|---|---|---|---|---|---|---|
|
Apparent Clearance (mL/hr/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
|
2177 Apparent Clearance (mL/hr/kg)
Standard Deviation 545.6
|
2100 Apparent Clearance (mL/hr/kg)
Standard Deviation 805.2
|
2012 Apparent Clearance (mL/hr/kg)
Standard Deviation 253.9
|
1765 Apparent Clearance (mL/hr/kg)
Standard Deviation 375.4
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 Days (+7)MRT (hr) of ascending doses of Scopolamine HBT administered by IM injection.
Outcome measures
| Measure |
Cohort 1 Scopolamine HBT 0.005 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.005mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 2 Scopolamine HBT 0.007 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.007mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 3 Scopolamine HBT 0.011 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.011mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 4 Scopolamine HBT 0.014 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.014mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 5 Scopolamine HBT 0.021 mg/kg
IM Dose of Scopolamine 0.021mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo
Placebo controlled
|
|---|---|---|---|---|---|---|
|
MRT (hr) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
|
3.18 MRT (hr)
Standard Deviation 0.647
|
3.02 MRT (hr)
Standard Deviation 0.639
|
3.01 MRT (hr)
Standard Deviation 0.355
|
3.81 MRT (hr)
Standard Deviation 0.802
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 Days (+7)AUClast (hr\*ug/mL) of ascending doses of Scopolamine HBT administered by IM injection.
Outcome measures
| Measure |
Cohort 1 Scopolamine HBT 0.005 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.005mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 2 Scopolamine HBT 0.007 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.007mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 3 Scopolamine HBT 0.011 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.011mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 4 Scopolamine HBT 0.014 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.014mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 5 Scopolamine HBT 0.021 mg/kg
IM Dose of Scopolamine 0.021mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo
Placebo controlled
|
|---|---|---|---|---|---|---|
|
AUClast (hr*ug/mL) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
|
2.36 AUClast (hr*ug/mL)
Standard Deviation 0.499
|
3.67 AUClast (hr*ug/mL)
Standard Deviation 1.293
|
5.47 AUClast (hr*ug/mL)
Standard Deviation 0.694
|
8.16 AUClast (hr*ug/mL)
Standard Deviation 1.940
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 Days (+7)AUCinfinity (hr\*ug/mL) of ascending doses of Scopolamine HBT administered by IM injection.
Outcome measures
| Measure |
Cohort 1 Scopolamine HBT 0.005 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.005mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 2 Scopolamine HBT 0.007 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.007mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 3 Scopolamine HBT 0.011 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.011mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 4 Scopolamine HBT 0.014 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.014mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 5 Scopolamine HBT 0.021 mg/kg
IM Dose of Scopolamine 0.021mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo
Placebo controlled
|
|---|---|---|---|---|---|---|
|
AUCinfinity (hr*ug/mL) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
|
2.4 AUCinfinity (hr*ug/mL)
Standard Deviation .5
|
3.7 AUCinfinity (hr*ug/mL)
Standard Deviation 1.32
|
5.5 AUCinfinity (hr*ug/mL)
Standard Deviation .68
|
8.3 AUCinfinity (hr*ug/mL)
Standard Deviation 1.98
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 Days (+7)Cmax/Dose (ug/mL)/(mg/kg) of ascending doses of Scopolamine HBT administered by IM injection.
Outcome measures
| Measure |
Cohort 1 Scopolamine HBT 0.005 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.005mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 2 Scopolamine HBT 0.007 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.007mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 3 Scopolamine HBT 0.011 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.011mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 4 Scopolamine HBT 0.014 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.014mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 5 Scopolamine HBT 0.021 mg/kg
IM Dose of Scopolamine 0.021mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo
Placebo controlled
|
|---|---|---|---|---|---|---|
|
Cmax/Dose (ug/mL)/(mg/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
|
133 Cmax/Dose (ug/mL)/(mg/kg)
Standard Deviation 57.3
|
153 Cmax/Dose (ug/mL)/(mg/kg)
Standard Deviation 75.6
|
139 Cmax/Dose (ug/mL)/(mg/kg)
Standard Deviation 45.5
|
137 Cmax/Dose (ug/mL)/(mg/kg)
Standard Deviation 32.5
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 Days (+7)AUCinfinity/Dose (hr\*ug/mL)/(mg/kg) of ascending doses of Scopolamine HBT administered by IM injection.
Outcome measures
| Measure |
Cohort 1 Scopolamine HBT 0.005 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.005mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 2 Scopolamine HBT 0.007 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.007mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 3 Scopolamine HBT 0.011 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.011mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 4 Scopolamine HBT 0.014 mg/kg
n=6 Participants
IM Dose of Scopolamine 0.014mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 5 Scopolamine HBT 0.021 mg/kg
IM Dose of Scopolamine 0.021mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo
Placebo controlled
|
|---|---|---|---|---|---|---|
|
AUCinfinity/Dose (hr*ug/mL)/(mg/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
|
481 AUCinfinity/Dose (hr*ug/mL)/(mg/kg)
Standard Deviation 100.3
|
535 AUCinfinity/Dose (hr*ug/mL)/(mg/kg)
Standard Deviation 188.6
|
504 AUCinfinity/Dose (hr*ug/mL)/(mg/kg)
Standard Deviation 62.5
|
590 AUCinfinity/Dose (hr*ug/mL)/(mg/kg)
Standard Deviation 140.4
|
—
|
—
|
Adverse Events
Cohort 1 Scopolamine HBT 0.005 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2 Scopolamine HBT 0.007 mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 3 Scopolamine HBT 0.011 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 4 Scopolamine HBT 0.014 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 5 Scopolamine HBT 0.021 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 Scopolamine HBT 0.005 mg/kg
n=6 participants at risk
IM Dose of Scopolamine 0.005mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 2 Scopolamine HBT 0.007 mg/kg
n=6 participants at risk
IM Dose of Scopolamine 0.007mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 3 Scopolamine HBT 0.011 mg/kg
n=6 participants at risk
IM Dose of Scopolamine 0.011mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 4 Scopolamine HBT 0.014 mg/kg
n=6 participants at risk
IM Dose of Scopolamine 0.014mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Cohort 5 Scopolamine HBT 0.021 mg/kg
IM Dose of Scopolamine 0.021mg/kg verses Placebo once on Day 1
Scopolamine Hydrobromide Trihydrate: Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo
n=8 participants at risk
Placebo controlled
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
33.3%
2/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
50.0%
3/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
100.0%
6/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
83.3%
5/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
—
0/0 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
12.5%
1/8 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
66.7%
4/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
50.0%
3/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
100.0%
6/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
—
0/0 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
0.00%
0/8 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
0.00%
0/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
16.7%
1/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
33.3%
2/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
—
0/0 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
0.00%
0/8 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
|
General disorders
Injection site pain
|
16.7%
1/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
33.3%
2/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
33.3%
2/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
33.3%
2/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
—
0/0 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
37.5%
3/8 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
|
General disorders
Injection site paraesthesia
|
33.3%
2/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
16.7%
1/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
0.00%
0/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
33.3%
2/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
—
0/0 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
25.0%
2/8 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
|
General disorders
Injection site hypoaesthesia
|
16.7%
1/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
0.00%
0/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
16.7%
1/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
33.3%
2/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
—
0/0 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
25.0%
2/8 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
|
Gastrointestinal disorders
Dry mouth
|
66.7%
4/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
50.0%
3/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
33.3%
2/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
16.7%
1/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
—
0/0 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
0.00%
0/8 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
0.00%
0/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
0.00%
0/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
50.0%
3/6 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
—
0/0 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
0.00%
0/8 • AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.
Cohort 5 number of participants affected and at risk is zero due to sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI cannot publish without written authorization from the DOD.
- Publication restrictions are in place
Restriction type: OTHER