Trial Outcomes & Findings for FX-322 in Sensorineural Hearing Loss (NCT NCT03616223)
NCT ID: NCT03616223
Last Updated: 2022-11-14
Results Overview
Treatment-emergent adverse events (TEAE) were defined as any untoward medical occurrence in a subject administered study drug that does not necessarily have a causal relationship with the treatment and were collected from the time of first dose through end of study (day 90). In particular, audiometric and otoscopic TEAEs were recorded per the American Speech-Language-Hearing Association (ASHA) guidelines.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Baseline through Day 90
Results posted on
2022-11-14
Participant Flow
23 participants who met all inclusion criteria and no exclusion criteria were enrolled at a single clinic site.
23 participants were randomized into one of four treatment groups using a 1:1 allocation ratio for dose cohort (approximately 12 in each cohort) and a 2:1 allocation ratio for study drug (approximately 8 FX-322:4 placebo) within each cohort. Subjects received a single dose of FX-322L (0.05mL), FX-322H (0.2mL), or matching placebo.
Participant milestones
| Measure |
Placebo-Low Dose
Single intratympanic injection of placebo into affected ear
|
Placebo-High Dose
Single intratympanic injection of placebo into affected ear
|
FX-322 Low Dose
Single intratympanic injection of FX-322 (laduviglusib 0.157mg/sodium valproate 4.43mg) into affected ear
|
FX-322 High Dose
Single intratympanic injection of FX-322 (laduviglusib 0.628mg/sodium valproate 17.72mg) into affected ear
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
7
|
8
|
|
Overall Study
COMPLETED
|
4
|
4
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FX-322 in Sensorineural Hearing Loss
Baseline characteristics by cohort
| Measure |
Placebo-Low Dose
n=4 Participants
Single intratympanic injection of placebo into affected ear
|
Placebo-High Dose
n=4 Participants
Single intratympanic injection of placebo into affected ear
|
FX-322 Low Dose
n=7 Participants
Single intratympanic injection of FX-322 (laduviglusib 0.157mg/sodium valproate 4.43mg) into affected ear
|
FX-322 High Dose
n=8 Participants
Single intratympanic injection of FX-322 (laduviglusib 0.628mg/sodium valproate 17.72mg) into affected ear
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
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
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
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
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
8 participants
n=4 Participants
|
23 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 90Population: Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
Treatment-emergent adverse events (TEAE) were defined as any untoward medical occurrence in a subject administered study drug that does not necessarily have a causal relationship with the treatment and were collected from the time of first dose through end of study (day 90). In particular, audiometric and otoscopic TEAEs were recorded per the American Speech-Language-Hearing Association (ASHA) guidelines.
Outcome measures
| Measure |
Placebo-Low Dose
n=4 Participants
Single intratympanic injection of placebo into affected ear
|
Placebo-High Dose
n=4 Participants
Single intratympanic injection of placebo into affected ear
|
Pooled Placebo
n=8 Participants
All participants receiving placebo
|
FX-322 Low Dose
n=7 Participants
Single intratympanic injection of FX-322 (laduviglusib 0.157mg/sodium valproate 4.43mg) into affected ear
|
FX-322 High Dose
n=8 Participants
Single intratympanic injection of FX-322 (laduviglusib 0.628mg/sodium valproate 17.72mg) into affected ear
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs)
|
2 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dosePopulation: Pharmacokinetic Analysis Set = All subjects in the Safety Analysis Set with measurable plasma concentrations
Maximum concentration (Cmax) of FX-322 (Laduviglusib and Sodium Valproate) directly from individual concentration-time data
Outcome measures
| Measure |
Placebo-Low Dose
n=7 Participants
Single intratympanic injection of placebo into affected ear
|
Placebo-High Dose
n=8 Participants
Single intratympanic injection of placebo into affected ear
|
Pooled Placebo
All participants receiving placebo
|
FX-322 Low Dose
Single intratympanic injection of FX-322 (laduviglusib 0.157mg/sodium valproate 4.43mg) into affected ear
|
FX-322 High Dose
Single intratympanic injection of FX-322 (laduviglusib 0.628mg/sodium valproate 17.72mg) into affected ear
|
|---|---|---|---|---|---|
|
Cmax
Cmax of laduviglusib
|
0.62 ng/mL
Standard Deviation 0.191
|
0.967 ng/mL
Standard Deviation 0.361
|
—
|
—
|
—
|
|
Cmax
Cmax of sodium valproate
|
345 ng/mL
Standard Deviation 94.9
|
767 ng/mL
Standard Deviation 309
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dosePopulation: Pharmacokinetic Analysis Set = All subjects in the Safety Analysis Set with measurable plasma concentrations
Time to reach maximum concentration of FX-322 (Laduviglusib and Sodium Valproate) directly from individual concentration-time data
Outcome measures
| Measure |
Placebo-Low Dose
n=7 Participants
Single intratympanic injection of placebo into affected ear
|
Placebo-High Dose
n=8 Participants
Single intratympanic injection of placebo into affected ear
|
Pooled Placebo
All participants receiving placebo
|
FX-322 Low Dose
Single intratympanic injection of FX-322 (laduviglusib 0.157mg/sodium valproate 4.43mg) into affected ear
|
FX-322 High Dose
Single intratympanic injection of FX-322 (laduviglusib 0.628mg/sodium valproate 17.72mg) into affected ear
|
|---|---|---|---|---|---|
|
Tmax
Tmax of laduviglusib
|
0.95 hr
Standard Deviation 0.206
|
1.63 hr
Standard Deviation 1.06
|
—
|
—
|
—
|
|
Tmax
Tmax of sodium valproate
|
2.88 hr
Standard Deviation 2.49
|
2.38 hr
Standard Deviation 1.06
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dosePopulation: Pharmacokinetic Analysis Set = All subjects in the Safety Analysis Set with measurable plasma concentrations
Area under the concentration-time curve of FX-322 (Laduviglusib and Sodium Valproate) from time zero to the time of the last quantifiable concentration, calculated using the linear trapezoidal rule
Outcome measures
| Measure |
Placebo-Low Dose
n=7 Participants
Single intratympanic injection of placebo into affected ear
|
Placebo-High Dose
n=8 Participants
Single intratympanic injection of placebo into affected ear
|
Pooled Placebo
All participants receiving placebo
|
FX-322 Low Dose
Single intratympanic injection of FX-322 (laduviglusib 0.157mg/sodium valproate 4.43mg) into affected ear
|
FX-322 High Dose
Single intratympanic injection of FX-322 (laduviglusib 0.628mg/sodium valproate 17.72mg) into affected ear
|
|---|---|---|---|---|---|
|
AUClast
AUClast of laduviglusib
|
1.71 ng*hr/mL
Standard Deviation 0.766
|
3.52 ng*hr/mL
Standard Deviation 1.31
|
—
|
—
|
—
|
|
AUClast
AUClast of sodium valproate
|
2730 ng*hr/mL
Standard Deviation 2790
|
13100 ng*hr/mL
Standard Deviation 4390
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dosePopulation: Pharmacokinetic Analysis Set = Subjects in the Safety Analysis Set with plasma concentrations above the limit of quantification. Concentration-time data below the limit of quantification (BLQ) were treated as zero. The values of 4 of 7 subjects in the low dose group and 2 of 8 subjects in the high dose group were BLQ and were thus excluded from the PAS for t1/2 as those values could not be calculated. The number analyzed for each data point below reflects quantifiable levels within in each group
The observed terminal elimination half-life of FX-322 (Laduviglusib and Sodium Valproate)
Outcome measures
| Measure |
Placebo-Low Dose
n=3 Participants
Single intratympanic injection of placebo into affected ear
|
Placebo-High Dose
n=6 Participants
Single intratympanic injection of placebo into affected ear
|
Pooled Placebo
All participants receiving placebo
|
FX-322 Low Dose
Single intratympanic injection of FX-322 (laduviglusib 0.157mg/sodium valproate 4.43mg) into affected ear
|
FX-322 High Dose
Single intratympanic injection of FX-322 (laduviglusib 0.628mg/sodium valproate 17.72mg) into affected ear
|
|---|---|---|---|---|---|
|
t1/2
t1/2 of laduviglusib
|
2.58 hr
Standard Deviation 0.878
|
2.47 hr
Standard Deviation 0.280
|
—
|
—
|
—
|
|
t1/2
t1/2 of sodium valproate
|
14.7 hr
Standard Deviation 3.86
|
20.1 hr
Standard Deviation 2.93
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dosePopulation: Pharmacokinetic Analysis Set = Subjects in the Safety Analysis Set with plasma concentrations above the limit of quantification. Concentration-time data below the limit of quantification (BLQ) were treated as zero. The values of 4 of 7 subjects in the low dose group and 2 of 8 subjects in the high dose group were BLQ and were thus excluded from the PAS for CL/F as those values could not be calculated. The number analyzed for each data point below reflects quantifiable levels within in each group
Apparent total body clearance after extravascular administration of FX-322 (Laduviglusib and Sodium Valproate)
Outcome measures
| Measure |
Placebo-Low Dose
n=3 Participants
Single intratympanic injection of placebo into affected ear
|
Placebo-High Dose
n=6 Participants
Single intratympanic injection of placebo into affected ear
|
Pooled Placebo
All participants receiving placebo
|
FX-322 Low Dose
Single intratympanic injection of FX-322 (laduviglusib 0.157mg/sodium valproate 4.43mg) into affected ear
|
FX-322 High Dose
Single intratympanic injection of FX-322 (laduviglusib 0.628mg/sodium valproate 17.72mg) into affected ear
|
|---|---|---|---|---|---|
|
CL/F
CL/F of laduviglusib
|
54.4 L/hr
Standard Deviation 9.93
|
147 L/hr
Standard Deviation 21.7
|
—
|
—
|
—
|
|
CL/F
CL/F of sodium valproate
|
0.510 L/hr
Standard Deviation 0.287
|
0.788 L/hr
Standard Deviation 0.308
|
—
|
—
|
—
|
Adverse Events
Placebo-Low Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo-High Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Pooled Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
FX-322 Low Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
FX-322 High Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo-Low Dose
n=4 participants at risk
Single intratympanic injection of placebo into affected ear
|
Placebo-High Dose
n=4 participants at risk
Single intratympanic injection of placebo into affected ear
|
Pooled Placebo
n=8 participants at risk
All participants receiving placebo
|
FX-322 Low Dose
n=7 participants at risk
Single intratympanic injection of FX-322 (laduviglusib 0.157mg/sodium valproate 4.43mg) into affected ear
|
FX-322 High Dose
n=8 participants at risk
Single intratympanic injection of FX-322 (laduviglusib 0.628mg/sodium valproate 17.72mg) into affected ear
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear Discomfort
|
25.0%
1/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
25.0%
1/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
25.0%
2/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
71.4%
5/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
50.0%
4/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Ear and labyrinth disorders
Ear Pain
|
25.0%
1/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
50.0%
2/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
37.5%
3/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
14.3%
1/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
37.5%
3/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Ear and labyrinth disorders
Deafness
|
25.0%
1/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
12.5%
1/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
12.5%
1/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Ear and labyrinth disorders
Ear Pruritus
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
25.0%
1/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
12.5%
1/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
14.3%
1/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Ear and labyrinth disorders
Paraesthesia Ear
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
12.5%
1/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
12.5%
1/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Ear and labyrinth disorders
Tympanic Membrace Perforation
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
12.5%
1/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
General disorders
Injection Site Pain
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
25.0%
1/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
12.5%
1/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
25.0%
1/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
25.0%
2/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
25.0%
2/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
14.3%
1/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
12.5%
1/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Nervous system disorders
Parosmia
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
12.5%
1/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Infections and infestations
Furuncle
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
25.0%
1/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
12.5%
1/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
25.0%
1/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
12.5%
1/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Infections and infestations
Viral Infection
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
12.5%
1/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
14.3%
1/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
14.3%
1/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
12.5%
1/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
14.3%
1/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
12.5%
1/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/4 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
14.3%
1/7 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
0.00%
0/8 • Baseline through Day 90
Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs must obtain sponsor's written consent before publishing or presenting the trial results.
- Publication restrictions are in place
Restriction type: OTHER