Trial Outcomes & Findings for Phase 1 Study of ELX-02 in Healthy Adult Subjects (NCT NCT03309605)
NCT ID: NCT03309605
Last Updated: 2021-03-16
Results Overview
Day 1 Area under the curve (AUC0-24) of ELX-02 plasma concentration following the subcutaneous (SC) dose on Day 1 to 24 hours post-ose
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
62 participants
Primary outcome timeframe
Day 1: pre-dose, 15 min, 30 min, 45 min, 1h, 3h, 6h, 12h, 24h, post-dose
Results posted on
2021-03-16
Participant Flow
All subjects were treated at medical clinics. The first patient was enrolled on 22 November 2017 and the last subject visit occurred on 18 July 2019.
Nine (9) subjects were to be randomized to receive ELX-02 or placebo at the 2:1 ratio in each cohort. However, only 8 subjects were randomized in Cohort 2. Subjects who received placebo in any of the 7 cohorts were pooled in the All Placebo group.
Participant milestones
| Measure |
Cohort 1
0.1 mg/kg Concentration 50 mg/mL, twice a week for 9 doses
|
Cohort 2
0.3 mg/kg Concentration 50 mg/mL, twice a week for 9 doses
|
Cohort 3
1.0 mg/kg Concentration 100 mg/mL, twice a week for 9 doses
|
Cohort 4
2.5 mg/kg Concentration 100 mg/mL, twice a week for 9 doses
|
Cohort 5
1.0 mg/kg Concentration 50 mg/mL, twice a week for 9 doses
|
Cohort 6
2.5 mg/kg Concentration 50 mg/mL, twice a week for 9 doses
|
Cohort 7
5.0 mg/kg Concentration 50 mg/mL, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
6
|
6
|
6
|
6
|
6
|
21
|
|
Overall Study
COMPLETED
|
6
|
5
|
6
|
5
|
5
|
6
|
3
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
0
|
3
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1
0.1 mg/kg Concentration 50 mg/mL, twice a week for 9 doses
|
Cohort 2
0.3 mg/kg Concentration 50 mg/mL, twice a week for 9 doses
|
Cohort 3
1.0 mg/kg Concentration 100 mg/mL, twice a week for 9 doses
|
Cohort 4
2.5 mg/kg Concentration 100 mg/mL, twice a week for 9 doses
|
Cohort 5
1.0 mg/kg Concentration 50 mg/mL, twice a week for 9 doses
|
Cohort 6
2.5 mg/kg Concentration 50 mg/mL, twice a week for 9 doses
|
Cohort 7
5.0 mg/kg Concentration 50 mg/mL, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
Baseline Characteristics
Phase 1 Study of ELX-02 in Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
Cohort 1
n=6 Participants
0.1 mg/kg Concentration 50 mg/mL
|
Cohort 2
n=5 Participants
0.3 mg/kg Concentration 50 mg/mL
|
Cohort 3
n=6 Participants
1.0 mg/kg Concentration 100 mg/mL
|
Cohort 4
n=6 Participants
2.5 mg/kg Concentration 100 mg/mL
|
Cohort 5
n=6 Participants
1.0 mg/kg Concentration 50 mg/mL
|
Cohort 6
n=6 Participants
2.5 mg/kg Concentration 50 mg/mL
|
Cohort 7
n=6 Participants
5.0 mg/kg Concentration 50 mg/mL
|
All Placebo
n=21 Participants
0 mg/kg
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.2 years
STANDARD_DEVIATION 12.43 • n=5 Participants
|
36.0 years
STANDARD_DEVIATION 8.69 • n=7 Participants
|
37.7 years
STANDARD_DEVIATION 14.51 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 11.26 • n=4 Participants
|
37.8 years
STANDARD_DEVIATION 10.46 • n=21 Participants
|
44.8 years
STANDARD_DEVIATION 11.14 • n=10 Participants
|
33.5 years
STANDARD_DEVIATION 7.74 • n=115 Participants
|
38.9 years
STANDARD_DEVIATION 11.16 • n=24 Participants
|
38.5 years
STANDARD_DEVIATION 10.87 • n=42 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
21 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
14 Participants
n=24 Participants
|
41 Participants
n=42 Participants
|
|
Race (NIH/OMB)
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
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
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
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 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
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
19 Participants
n=24 Participants
|
54 Participants
n=42 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
Belgium
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=10 Participants
|
0 participants
n=115 Participants
|
18 participants
n=24 Participants
|
53 participants
n=42 Participants
|
|
Region of Enrollment
United States
|
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
|
6 participants
n=115 Participants
|
3 participants
n=24 Participants
|
9 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 15 min, 30 min, 45 min, 1h, 3h, 6h, 12h, 24h, post-dosePopulation: Plasma ELX-02 exposure was generally similar following SC administration of either a 50 or 100 mg/mL final diluted injection solution strength, indicating no formulation-related differences in PK, therefore the results from Cohorts 3 and 5, and Cohorts 4 and 6 were combined.
Day 1 Area under the curve (AUC0-24) of ELX-02 plasma concentration following the subcutaneous (SC) dose on Day 1 to 24 hours post-ose
Outcome measures
| Measure |
Cohort 1
n=6 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=12 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=12 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=6 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameters - Plasma AUC0-24
|
1105.126 ng*h/mL
Geometric Coefficient of Variation 15.261
|
3125.484 ng*h/mL
Geometric Coefficient of Variation 13.836
|
11018.22 ng*h/mL
Geometric Coefficient of Variation 12.436
|
28235.823 ng*h/mL
Geometric Coefficient of Variation 16.255
|
61906.528 ng*h/mL
Geometric Coefficient of Variation 20.455
|
—
|
PRIMARY outcome
Timeframe: Day 29: pre-dose, 15 min, 30 min, 45 min, 1h, 3h, 6h, 12h, 24h, post-dosePopulation: Plasma ELX-02 exposure was generally similar following SC administration of either a 50 or 100 mg/mL final diluted injection solution strength, indicating no formulation-related differences in PK, therefore the results from Cohorts 3 and 5, and Cohorts 4 and 6 were combined.
Day 29 Area under the curve (AUC0-24) of ELX-02 plasma concentration following the subcutaneous (SC) dose on Day 29 to 24 hours post-dose
Outcome measures
| Measure |
Cohort 1
n=6 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=12 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=12 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=6 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameters- Plasma AUC0-24
|
1215.098 ng*h/mL
Geometric Coefficient of Variation 15.431
|
3109.978 ng*h/mL
Geometric Coefficient of Variation 16.601
|
10847.306 ng*h/mL
Geometric Coefficient of Variation 14.098
|
29651.700 ng*h/mL
Geometric Coefficient of Variation 23.223
|
54749.370 ng*h/mL
Geometric Coefficient of Variation 13.770
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 15 min, 30 min, 45 min, 1h, 3h, 6h, 12h, 24h, 36h, 48h, 72h, post-dosePopulation: Plasma ELX-02 exposure was generally similar following SC administration of either a 50 or 100 mg/mL final diluted injection solution strength, indicating no formulation-related differences in PK, therefore the results from Cohorts 3 and 5, and Cohorts 4 and 6 were combined.
Day 1 Peak Plasma Concentration (Cmax) of ELX-02 following the subcutaneous (SC) dose on Day 1 to 72 hours post-dose
Outcome measures
| Measure |
Cohort 1
n=6 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=12 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=12 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=6 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameters - Plasma Cmax
|
284.710 ng/mL
Geometric Coefficient of Variation 21.060
|
1003.266 ng/mL
Geometric Coefficient of Variation 5.766
|
2880.233 ng/mL
Geometric Coefficient of Variation 11.647
|
7721.256 ng/mL
Geometric Coefficient of Variation 6.387
|
15912.090 ng/mL
Geometric Coefficient of Variation 17.265
|
—
|
PRIMARY outcome
Timeframe: Day 29: pre-dose, 15 min, 30 min, 45 min, 1h, 3h, 6h, 12h, 24h, 36h, 48h, 72h post-dosePopulation: Plasma ELX-02 exposure was generally similar following SC administration of either a 50 or 100 mg/mL final diluted injection solution strength, indicating no formulation-related differences in PK, therefore the results from Cohorts 3 and 5, and Cohorts 4 and 6 were combined.
Day 29 Peak Plasma Concentration (Cmax) of ELX-02 following the subcutaneous (SC) dose on Day 29 to 72 hours post-dose
Outcome measures
| Measure |
Cohort 1
n=6 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=12 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=12 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=6 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameters - Plasma Cmax
|
342.779 ng/mL
Geometric Coefficient of Variation 12.021
|
961.448 ng/mL
Geometric Coefficient of Variation 7.460
|
2806.966 ng/mL
Geometric Coefficient of Variation 16.403
|
7852.172 ng/mL
Geometric Coefficient of Variation 12.342
|
15435.789 ng/mL
Geometric Coefficient of Variation 13.872
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 15 min, 30 min, 45 min, 1h, 3h, 6h, 12h, 24h, 36h, 48h, 72h post dosePopulation: Plasma ELX-02 exposure was generally similar following SC administration of either a 50 or 100 mg/mL final diluted injection solution strength, indicating no formulation-related differences in PK, therefore the results from Cohorts 3 and 5, and Cohorts 4 and 6 were combined.
Day 1 Area under the curve (AUC0-inf) of ELX-02 plasma concentration following the subcutaneous (SC) dose on Day 1 extrapolated to infinity
Outcome measures
| Measure |
Cohort 1
n=6 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=12 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=12 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=6 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter - Plasma AUC0-inf
|
1107.272 ng*hr/mL
Geometric Coefficient of Variation 15.345
|
3127.964 ng*hr/mL
Geometric Coefficient of Variation 13.898
|
11036.305 ng*hr/mL
Geometric Coefficient of Variation 12.631
|
28335.680 ng*hr/mL
Geometric Coefficient of Variation 16.468
|
62142.763 ng*hr/mL
Geometric Coefficient of Variation 20.712
|
—
|
PRIMARY outcome
Timeframe: Day 29: pre-dose, 15 min, 30 min, 45 min, 1h, 3h, 6h, 12h, 24h, 36h, 48h, 72h post dosePopulation: Plasma ELX-02 exposure was generally similar following SC administration of either a 50 or 100 mg/mL final diluted injection solution strength, indicating no formulation-related differences in PK, therefore the results from Cohorts 3 and 5, and Cohorts 4 and 6 were combined.
Day 29 Area under the curve (AUC0-inf) of ELX-02 plasma concentration following the subcutaneous (SC) dose on Day 29 extrapolated to infinity
Outcome measures
| Measure |
Cohort 1
n=6 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=12 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=12 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=6 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter - Plasma AUC0-inf
|
1216.448 ng*h/mL
Geometric Coefficient of Variation 15.428
|
3114.486 ng*h/mL
Geometric Coefficient of Variation 16.704
|
10862.927 ng*h/mL
Geometric Coefficient of Variation 14.239
|
29778.143 ng*h/mL
Geometric Coefficient of Variation 23.469
|
54933.538 ng*h/mL
Geometric Coefficient of Variation 13.979
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 15 min, 30 min, 45 min, 1h, 3h, 6h, 12h, 24h, 36h, 48h, 72h post-dosePopulation: Plasma ELX-02 exposure was generally similar following SC administration of either a 50 or 100 mg/mL final diluted injection solution strength, indicating no formulation-related differences in PK, therefore the results from Cohorts 3 and 5, and Cohorts 4 and 6 were combined.
Day 1 Time to maximum concentration (Tmax) of ELX-02 plasma concentrations following the subcutaneous (SC) dose on Day 1
Outcome measures
| Measure |
Cohort 1
n=6 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=12 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=12 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=6 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter - Plasma Tmax
|
1.00 hour
Interval 0.5 to 3.0
|
0.75 hour
Interval 0.5 to 1.0
|
1.00 hour
Interval 0.75 to 1.0
|
1.00 hour
Interval 0.75 to 1.0
|
0.86 hour
Interval 0.73 to 1.0
|
—
|
PRIMARY outcome
Timeframe: Day 29: pre-dose, 15 min, 30 min, 45 min, 1h, 3h, 6h, 12h, 24h, 36h, 48h, 72h post-doseDay 29 Time to maximum concentration (Tmax) of ELX-02 plasma concentrations following the subcutaneous (SC) dose on Day 29
Outcome measures
| Measure |
Cohort 1
n=5 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=11 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=11 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=3 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter Plasma - Tmax
|
1.00 hour
Interval 0.5 to 1.0
|
0.75 hour
Interval 0.75 to 1.0
|
1.00 hour
Interval 0.75 to 1.0
|
0.75 hour
Interval 0.75 to 1.0
|
0.98 hour
Interval 0.73 to 0.98
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 24 hrPopulation: Plasma ELX-02 exposure was generally similar following SC administration of either a 50 or 100 mg/mL final diluted injection solution strength, indicating no formulation-related differences in PK, therefore the results from Cohorts 3 and 5, and Cohorts 4 and 6 were combined.
Accumulation ratio, calculated as AUC24h Day29/AUC24h Day 1
Outcome measures
| Measure |
Cohort 1
n=4 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=11 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=11 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=3 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter - Plasma Rac(AUC24h)
|
1.093 Ratio
Geometric Coefficient of Variation 7.497
|
0.995 Ratio
Geometric Coefficient of Variation 6.622
|
0.984 Ratio
Geometric Coefficient of Variation 7.892
|
1.056 Ratio
Geometric Coefficient of Variation 14.161
|
0.911 Ratio
Geometric Coefficient of Variation 13.377
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 29Accumulation ratio, calculated as Cmax Day29/Cmax Day 1
Outcome measures
| Measure |
Cohort 1
n=5 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=11 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=11 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=3 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter - Plasma RAC(Cmax)
|
1.217 Ratio
Geometric Coefficient of Variation 15.278
|
0.958 Ratio
Geometric Coefficient of Variation 7.429
|
0.976 Ratio
Geometric Coefficient of Variation 12.401
|
1.018 Ratio
Geometric Coefficient of Variation 15.413
|
0.941 Ratio
Geometric Coefficient of Variation 1.262
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose and during 0-12h, 12-24h, 24-48h, and 48-72h post-dosePopulation: Plasma ELX-02 exposure was generally similar following SC administration of either a 50 or 100 mg/mL final diluted injection solution strength, indicating no formulation-related differences in PK, therefore the results from Cohorts 3 and 5, and Cohorts 4 and 6 were combined.
Day 1 Cumulative amount of unchanged drug excreted into urine (Ae72h) of ELX-02 following the subcutaneous (SC) dose on Day 1
Outcome measures
| Measure |
Cohort 1
n=6 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=12 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=12 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=6 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Urine Pharmacokinetics Parameter - Ae72h
|
6.702 mg
Geometric Coefficient of Variation 16.721
|
15.177 mg
Geometric Coefficient of Variation 8.524
|
58.270 mg
Geometric Coefficient of Variation 20.046
|
160.665 mg
Geometric Coefficient of Variation 11.622
|
332.467 mg
Geometric Coefficient of Variation 18.102
|
—
|
PRIMARY outcome
Timeframe: Day 29: pre-dose and during 0-12h, 12-24h, 24-48h, and 48-72h post-dosePopulation: Plasma ELX-02 exposure was generally similar following SC administration of either a 50 or 100 mg/mL final diluted injection solution strength, indicating no formulation-related differences in PK, therefore the results from Cohorts 3 and 5, and Cohorts 4 and 6 were combined.
Day 29 Cumulative amount of unchanged drug excreted into urine (Ae72h) of ELX-02 following the subcutaneous (SC) dose on Day 29
Outcome measures
| Measure |
Cohort 1
n=6 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=12 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=12 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=6 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Urine Pharmacokinetics Parameter - Ae72h
|
6.331 mg
Geometric Coefficient of Variation 28.505
|
15.021 mg
Geometric Coefficient of Variation 9.189
|
66.354 mg
Geometric Coefficient of Variation 15.505
|
162.609 mg
Geometric Coefficient of Variation 12.742
|
399.302 mg
Geometric Coefficient of Variation 14.863
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose and during 0-12h, 12-24h, 24-48h, and 48-72h post-dosePopulation: Plasma ELX-02 exposure was generally similar following SC administration of either a 50 or 100 mg/mL final diluted injection solution strength, indicating no formulation-related differences in PK, therefore the results from Cohorts 3 and 5, and Cohorts 4 and 6 were combined.
Day 1 Maximum rate of urinary extraction (Rmax) of EXL-02 in each collection time interval following the subcutaneous (SC) dose on Day 1
Outcome measures
| Measure |
Cohort 1
n=6 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=12 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=12 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=6 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Urine Pharmacokinetic Parameter - Rmax
|
1.846 mg/h
Geometric Coefficient of Variation 30.561
|
4.759 mg/h
Geometric Coefficient of Variation 6.706
|
16.132 mg/h
Geometric Coefficient of Variation 15.540
|
41.587 mg/h
Geometric Coefficient of Variation 21.200
|
69.304 mg/h
Geometric Coefficient of Variation 13.495
|
—
|
PRIMARY outcome
Timeframe: Day 29: pre-dose and during 0-12h, 12-24h, 24-48h, and 48-72h post-dosePopulation: Plasma ELX-02 exposure was generally similar following SC administration of either a 50 or 100 mg/mL final diluted injection solution strength, indicating no formulation-related differences in PK, therefore the results from Cohorts 3 and 5, and Cohorts 4 and 6 were combined.
Day 29 Maximum rate of urinary extraction (Rmax) of ELX-02 in each collection time interval following the subcutaneous (SC) dose on Day 29
Outcome measures
| Measure |
Cohort 1
n=6 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=12 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=12 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=6 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Urine Pharmacokinetic Parameter - Rmax
|
1.950 mg/h
Geometric Coefficient of Variation 37.938
|
5.028 mg/h
Geometric Coefficient of Variation 15.875
|
18.327 mg/h
Geometric Coefficient of Variation 23.862
|
40.607 mg/h
Geometric Coefficient of Variation 18.389
|
89.796 mg/h
Geometric Coefficient of Variation 14.725
|
—
|
PRIMARY outcome
Timeframe: 12 hoursPercent of dose excreted (Fe) in urine on Day 1
Outcome measures
| Measure |
Cohort 1
n=6 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=12 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=12 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=6 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Urine Pharmacokinetics Parameter - Fe12h Day 1
|
79.572 percentage of drug excreted
Geometric Coefficient of Variation 10.030
|
79.440 percentage of drug excreted
Geometric Coefficient of Variation 6.178
|
76.028 percentage of drug excreted
Geometric Coefficient of Variation 17.403
|
89.639 percentage of drug excreted
Geometric Coefficient of Variation 9.227
|
83.362 percentage of drug excreted
Geometric Coefficient of Variation 5.495
|
—
|
PRIMARY outcome
Timeframe: 12 h on Day 29Percent of dose excreted (Fe) in urine on Day 29
Outcome measures
| Measure |
Cohort 1
n=5 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=11 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=11 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=3 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Urine Pharmacokinetics Parameter - Fe 12h on Day 29
|
76.095 percentage of drug excreted
Geometric Coefficient of Variation 14.874
|
78.398 percentage of drug excreted
Geometric Coefficient of Variation 3.615
|
88.130 percentage of drug excreted
Geometric Coefficient of Variation 15.218
|
88.914 percentage of drug excreted
Geometric Coefficient of Variation 4.157
|
94.219 percentage of drug excreted
Geometric Coefficient of Variation 7.407
|
—
|
PRIMARY outcome
Timeframe: 24 hoursRenal clearance on Day 1 (CLR=Ae24h/plasmaAUC24h)
Outcome measures
| Measure |
Cohort 1
n=5 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=12 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=12 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=6 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Urine Pharmacokinetics Parameter - CLR24h on Day 1
|
5.871 L/h
Geometric Coefficient of Variation 22.645
|
4.823 L/h
Geometric Coefficient of Variation 9.834
|
5.251 L/h
Geometric Coefficient of Variation 19.135
|
5.653 L/h
Geometric Coefficient of Variation 22.959
|
5.331 L/h
Geometric Coefficient of Variation 16.660
|
—
|
PRIMARY outcome
Timeframe: 24 hRenal clearance on Day 29 (CLR=Ae24h/plasmaAUC24h)
Outcome measures
| Measure |
Cohort 1
n=5 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=11 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=11 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=3 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Urine Pharmacokinetics Parameter - CLR24h
|
5.152 L/h
Geometric Coefficient of Variation 29.234
|
4.784 L/h
Geometric Coefficient of Variation 10.828
|
6.068 L/h
Geometric Coefficient of Variation 17.200
|
5.435 L/h
Geometric Coefficient of Variation 28.521
|
7.239 L/h
Geometric Coefficient of Variation 7.903
|
—
|
SECONDARY outcome
Timeframe: Day 1-29TEAEs are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the study treatment
Outcome measures
| Measure |
Cohort 1
n=6 Participants
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 Participants
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=12 Participants
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=12 Participants
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=6 Participants
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
n=21 Participants
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Number of Patients Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs)
At least 1 TEAE
|
3 Participants
|
5 Participants
|
11 Participants
|
12 Participants
|
6 Participants
|
14 Participants
|
|
Number of Patients Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs)
Related to study drug
|
1 Participants
|
5 Participants
|
10 Participants
|
12 Participants
|
6 Participants
|
9 Participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 3 and Cohort 5
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 4 and Cohort 6
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 7
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
All Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=6 participants at risk
0.1 mg/kg, twice a week for 9 doses
|
Cohort 2
n=5 participants at risk
0.3 mg/kg, twice a week for 9 doses
|
Cohort 3 and Cohort 5
n=12 participants at risk
1.0 mg/kg, twice a week for 9 doses
|
Cohort 4 and Cohort 6
n=12 participants at risk
2.5 mg/kg, twice a week for 9 doses
|
Cohort 7
n=6 participants at risk
5.0 mg/kg, twice a week for 9 doses
|
All Placebo
n=21 participants at risk
Placebo, twice a week for 9 doses
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
25.0%
3/12 • Number of events 4 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
16.7%
1/6 • Number of events 2 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
16.7%
2/12 • Number of events 3 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
16.7%
2/12 • Number of events 2 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
4.8%
1/21 • Number of events 1 • From the date of signing the consent form until Day 36
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
General disorders
Injection site reaction
|
16.7%
1/6 • Number of events 1 • From the date of signing the consent form until Day 36
|
100.0%
5/5 • Number of events 8 • From the date of signing the consent form until Day 36
|
83.3%
10/12 • Number of events 23 • From the date of signing the consent form until Day 36
|
100.0%
12/12 • Number of events 59 • From the date of signing the consent form until Day 36
|
100.0%
6/6 • Number of events 66 • From the date of signing the consent form until Day 36
|
28.6%
6/21 • Number of events 7 • From the date of signing the consent form until Day 36
|
|
General disorders
Injection site discoloration
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
83.3%
5/6 • Number of events 5 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
General disorders
Injection site induration
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
25.0%
3/12 • Number of events 5 • From the date of signing the consent form until Day 36
|
25.0%
3/12 • Number of events 5 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
General disorders
Injection site pain
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
33.3%
4/12 • Number of events 8 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
General disorders
Injection site hematoma
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
25.0%
3/12 • Number of events 3 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
14.3%
3/21 • Number of events 3 • From the date of signing the consent form until Day 36
|
|
General disorders
Vessel puncture site hematoma
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
16.7%
2/12 • Number of events 2 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
General disorders
Injection site pruritus
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
General disorders
Injection site scab
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
16.7%
1/6 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Number of events 1 • From the date of signing the consent form until Day 36
|
20.0%
1/5 • Number of events 1 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
9.5%
2/21 • Number of events 2 • From the date of signing the consent form until Day 36
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
20.0%
1/5 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
16.7%
1/6 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Investigations
Audiogram abnormal
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
33.3%
2/6 • Number of events 4 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
9.5%
2/21 • Number of events 2 • From the date of signing the consent form until Day 36
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
16.7%
1/6 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
4.8%
1/21 • Number of events 1 • From the date of signing the consent form until Day 36
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
9.5%
2/21 • Number of events 2 • From the date of signing the consent form until Day 36
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • From the date of signing the consent form until Day 36
|
80.0%
4/5 • Number of events 4 • From the date of signing the consent form until Day 36
|
16.7%
2/12 • Number of events 3 • From the date of signing the consent form until Day 36
|
16.7%
2/12 • Number of events 2 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
9.5%
2/21 • Number of events 2 • From the date of signing the consent form until Day 36
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
20.0%
1/5 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
20.0%
1/5 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
20.0%
1/5 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/5 • From the date of signing the consent form until Day 36
|
0.00%
0/12 • From the date of signing the consent form until Day 36
|
8.3%
1/12 • Number of events 1 • From the date of signing the consent form until Day 36
|
0.00%
0/6 • From the date of signing the consent form until Day 36
|
0.00%
0/21 • From the date of signing the consent form until Day 36
|
Additional Information
Executive Director Clinical Trials
Eloxx Pharmaceuticals
Phone: 1-781-577-5300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place