Trial Outcomes & Findings for A SAD/MAD Study of Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Volunteers (NCT NCT04103034)
NCT ID: NCT04103034
Last Updated: 2024-03-18
Results Overview
Any AE or bleeding event related to study treatment
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
112 participants
Primary outcome timeframe
Baseline through 8 weeks after dosing up to 56 days
Results posted on
2024-03-18
Participant Flow
Subjects were recruited from the Medical University of Vienna Phase 1 Unit's database of Normal Human Volunteers and a recruitment vendor was also employed.
Participant milestones
| Measure |
BT200 0.18mg
Subjects will receive a single subcutaneous dose of BT200 0.18mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 0.6mg
Subjects will receive a single subcutaneous dose of BT200 0.6mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 1.8mg
Subjects will receive a single subcutaneous dose of BT200 1.8mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 6.0mg
Subjects will receive a single subcutaneous dose of BT200 6.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 12.0mg
Subjects will receive a single subcutaneous dose of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24.0mg
Subjects will receive a single subcutaneous dose of BT200 24.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24.0mg Rep
Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
Placebo SAD
Subjects will receive a single subcutaneous dose of placebo
Placebo: Sterile saline for injection
|
BT200 Loading Dose 24.0mg, Maintenance Doses of 12.0 mg
Subjects will receive an initial subcutaneous loading doses of BT200 24.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 Loading Doses 48.0mg, Maintenance Doses of 24.0 mg
Subjects will receive an initial subcutaneous loading dose of BT200 48mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
Placebo MAD
Subjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo
Placebo: Sterile saline for injection
|
BT200 48.0mg + Desmopressin Challenge
Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection
|
Placebo + Desmopressin Challenge Dose
Subjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection
|
Placebo Infusion
Subjects will receive a single IV dose of placebo administered over 24 hours
Placebo: Sterile saline for injection
|
BT200 36.0mg
Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 48.0 mg
Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 18.0 mg
Subjects will receive a single subcutaneous dose of BT200 18.o mg
|
BT200 24mg IV Infusion
Subjects will receive a single IV dose of BT200 24mg administered over 24 hours
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
20
|
6
|
6
|
4
|
6
|
2
|
2
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
19
|
6
|
0
|
2
|
6
|
2
|
2
|
5
|
4
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
6
|
2
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A SAD/MAD Study of Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Volunteers
Baseline characteristics by cohort
| Measure |
BT200 0.18mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 0.18mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 0.6mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 0.6mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 1.8mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 1.8mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 6.0mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 6.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 12.0mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24.0mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 24.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24.0mg Rep
n=6 Participants
Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
Placebo SAD
n=20 Participants
Subjects will receive a single subcutaneous dose of placebo
Placebo: Sterile saline for injection
|
BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg
n=6 Participants
Subjects will receive an initial subcutaneous loading doses of BT200 12.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg
n=6 Participants
Subjects will receive an initial subcutaneous loading dose of BT200 24mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
Placebo MAD
n=4 Participants
Subjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo
Placebo: Sterile saline for injection
|
BT200 48.0mg + Desmopressin Challenge
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection
|
Placebo + Desmopressin Challenge Dose
n=2 Participants
Subjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection
|
Placebo Infusion
n=2 Participants
Subjects will receive a single IV dose of placebo administered over 24 hours
Placebo: Sterile saline for injection
|
BT200 36.0mg
n=6 Participants
Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 48.0 mg
n=6 Participants
Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 18.0 mg
n=6 Participants
Subjects will receive a single subcutaneous (SC) dose of BT200 18.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT 200 24mg IV Infusion
n=6 Participants
Subjects will receive a single IV dose of BT200 24mg administered over 24 hours
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
3 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
19 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
5 Participants
|
4 Participants
n=19 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=2 Participants
|
6 Participants
n=102 Participants
|
109 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
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
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
11 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
18 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
6 Participants
|
3 Participants
n=19 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=3 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=2 Participants
|
6 Participants
n=102 Participants
|
101 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
20 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
6 Participants
|
4 Participants
n=19 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=2 Participants
|
6 Participants
n=102 Participants
|
112 Participants
n=6 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=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=102 Participants
|
5 Participants
n=6 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=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 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
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
20 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
5 Participants
|
4 Participants
n=19 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=2 Participants
|
5 Participants
n=102 Participants
|
106 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=6 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
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
Austria
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
6 participants
n=206 Participants
|
6 participants
n=7 Participants
|
6 participants
n=31 Participants
|
6 participants
n=30 Participants
|
6 participants
n=3 Participants
|
20 participants
n=6 Participants
|
6 participants
n=114 Participants
|
6 participants
|
4 participants
n=19 Participants
|
6 participants
n=4 Participants
|
2 participants
n=7 Participants
|
2 participants
n=7 Participants
|
6 participants
n=3 Participants
|
6 participants
n=4 Participants
|
6 participants
n=2 Participants
|
6 participants
n=102 Participants
|
112 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline through 8 weeks after dosing up to 56 daysPopulation: Safety population
Any AE or bleeding event related to study treatment
Outcome measures
| Measure |
BT200 0.18mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 0.18mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 0.6mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 0.6mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 1.8mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 1.8mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 6.0mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 6.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 12.0mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24.0mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 24.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24.0mg Rep
n=6 Participants
Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
Placebo SAD
n=20 Participants
Subjects will receive a single subcutaneous dose of placebo
Placebo: Sterile saline for injection
|
BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg
n=6 Participants
Subjects will receive an initial subcutaneous loading doses of BT200 12.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg
n=6 Participants
Subjects will receive an initial subcutaneous loading dose of BT200 24mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
Placebo MAD
n=4 Participants
Subjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo
Placebo: Sterile saline for injection
|
BT200 48.0mg + Desmopressin Challenge
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection
|
Placebo + Desmopressin Challenge Dose
n=2 Participants
Subjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection
|
Placebo Infusion
n=2 Participants
Subjects will receive a single IV dose of placebo administered over 24 hours
Placebo: Sterile saline for injection
|
BT200 36.0mg
n=6 Participants
Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 48.0 mg
n=6 Participants
Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 18.0 mg
n=6 Participants
Subjects will receive a single subcutaneous (SC) dose of BT200 18.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24mg IV Infusion
n=6 Participants
Subjects will receive a single IV dose of BT200 24mg administered over 24 hours
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline through 8 weeks after dosing up to 56 daysPopulation: Per protocol population-(h\*ug/mL)
Measured Area Under the Curve at timepoints pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d post dose
Outcome measures
| Measure |
BT200 0.18mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 0.18mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 0.6mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 0.6mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 1.8mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 1.8mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 6.0mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 6.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 12.0mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24.0mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 24.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24.0mg Rep
n=6 Participants
Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
Placebo SAD
n=6 Participants
Subjects will receive a single subcutaneous dose of placebo
Placebo: Sterile saline for injection
|
BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg
n=6 Participants
Subjects will receive an initial subcutaneous loading doses of BT200 12.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg
n=6 Participants
Subjects will receive an initial subcutaneous loading dose of BT200 24mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
Placebo MAD
n=6 Participants
Subjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo
Placebo: Sterile saline for injection
|
BT200 48.0mg + Desmopressin Challenge
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection
|
Placebo + Desmopressin Challenge Dose
n=6 Participants
Subjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection
|
Placebo Infusion
n=6 Participants
Subjects will receive a single IV dose of placebo administered over 24 hours
Placebo: Sterile saline for injection
|
BT200 36.0mg
Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 48.0 mg
Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 18.0 mg
Subjects will receive a single subcutaneous (SC) dose of BT200 18.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24mg IV Infusion
Subjects will receive a single IV dose of BT200 24mg administered over 24 hours
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Measured Area Under the Curve (AUC)
|
1.159 h*ug/mL
Standard Deviation 0.72594
|
5.405 h*ug/mL
Standard Deviation 2.1113
|
11.50 h*ug/mL
Standard Deviation 6.5663
|
64.39 h*ug/mL
Standard Deviation 22.534
|
161.6 h*ug/mL
Standard Deviation 43.427
|
259.5 h*ug/mL
Standard Deviation 99.216
|
265.3 h*ug/mL
Standard Deviation 59.127
|
409.4 h*ug/mL
Standard Deviation 32.347
|
806.8 h*ug/mL
Standard Deviation 187.25
|
675.9 h*ug/mL
Standard Deviation 204.80
|
366.2 h*ug/mL
Standard Deviation 78.610
|
638.8 h*ug/mL
Standard Deviation 90.467
|
220.3 h*ug/mL
Standard Deviation 64.58
|
555.4 h*ug/mL
Standard Deviation 126.99
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 8 weeks after dosing up to 56 daysPopulation: Per protocol population
Maximum plasma Concentration measured at pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d
Outcome measures
| Measure |
BT200 0.18mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 0.18mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 0.6mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 0.6mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 1.8mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 1.8mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 6.0mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 6.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 12.0mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24.0mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 24.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24.0mg Rep
n=6 Participants
Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
Placebo SAD
n=6 Participants
Subjects will receive a single subcutaneous dose of placebo
Placebo: Sterile saline for injection
|
BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg
n=6 Participants
Subjects will receive an initial subcutaneous loading doses of BT200 12.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg
n=6 Participants
Subjects will receive an initial subcutaneous loading dose of BT200 24mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
Placebo MAD
n=6 Participants
Subjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo
Placebo: Sterile saline for injection
|
BT200 48.0mg + Desmopressin Challenge
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection
|
Placebo + Desmopressin Challenge Dose
n=6 Participants
Subjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection
|
Placebo Infusion
n=6 Participants
Subjects will receive a single IV dose of placebo administered over 24 hours
Placebo: Sterile saline for injection
|
BT200 36.0mg
Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 48.0 mg
Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 18.0 mg
Subjects will receive a single subcutaneous (SC) dose of BT200 18.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24mg IV Infusion
Subjects will receive a single IV dose of BT200 24mg administered over 24 hours
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
0.01025 ug/mL
Standard Deviation 0.0055459
|
0.04688 ug/mL
Standard Deviation 0.018522
|
0.09432 ug/mL
Standard Deviation 0.035964
|
0.5087 ug/mL
Standard Deviation 0.18430
|
1.258 ug/mL
Standard Deviation 0.35540
|
2.092 ug/mL
Standard Deviation 0.07627
|
2.080 ug/mL
Standard Deviation 0.46217
|
3.013 ug/mL
Standard Deviation 0.25185
|
5.823 ug/mL
Standard Deviation 1.3606
|
6.598 ug/mL
Standard Deviation 2.6719
|
3.248 ug/mL
Standard Deviation 11724
|
5.525 ug/mL
Standard Deviation 0.95429
|
1.742 ug/mL
Standard Deviation 0.49545
|
5.037 ug/mL
Standard Deviation 1.3953
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 8 weeks after dosing up to 56 daysPopulation: per protocol population
Time to maximum plasma concentration measured at pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d
Outcome measures
| Measure |
BT200 0.18mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 0.18mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 0.6mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 0.6mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 1.8mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 1.8mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 6.0mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 6.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 12.0mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24.0mg
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 24.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24.0mg Rep
n=6 Participants
Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
Placebo SAD
n=6 Participants
Subjects will receive a single subcutaneous dose of placebo
Placebo: Sterile saline for injection
|
BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg
n=6 Participants
Subjects will receive an initial subcutaneous loading doses of BT200 12.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg
n=6 Participants
Subjects will receive an initial subcutaneous loading dose of BT200 24mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
Placebo MAD
n=6 Participants
Subjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo
Placebo: Sterile saline for injection
|
BT200 48.0mg + Desmopressin Challenge
n=6 Participants
Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection
|
Placebo + Desmopressin Challenge Dose
n=6 Participants
Subjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection
|
Placebo Infusion
n=6 Participants
Subjects will receive a single IV dose of placebo administered over 24 hours
Placebo: Sterile saline for injection
|
BT200 36.0mg
Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 48.0 mg
Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 18.0 mg
Subjects will receive a single subcutaneous (SC) dose of BT200 18.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24mg IV Infusion
Subjects will receive a single IV dose of BT200 24mg administered over 24 hours
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax)
|
111.867 (h)
Standard Deviation 111.7018
|
80.433 (h)
Standard Deviation 20.2385
|
72.364 (h)
Standard Deviation 22.0757
|
100.239 (h)
Standard Deviation 53.4433
|
72.761 (h)
Standard Deviation 21.4536
|
100.247 (h)
Standard Deviation 38.5146
|
88.517 (h)
Standard Deviation 19.7697
|
29.892 (h)
Standard Deviation 25.8845
|
12.811 (h)
Standard Deviation 17.9877
|
105.919 (h)
Standard Deviation 18.9321
|
139.647 (h)
Standard Deviation 46.6683
|
107.892 (h)
Standard Deviation 113.4475
|
100.247 (h)
Standard Deviation 38.5146
|
23.864 (h)
Standard Deviation 0.2642
|
—
|
—
|
—
|
—
|
Adverse Events
BT200 0.18mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BT200 0.6mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BT200 1.8mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BT200 6.0mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BT200 12.0mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BT200 24.0mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BT200 24.0mg Rep
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo SAD
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo MAD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BT200 48.0mg + Desmopressin Challenge
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo + Desmopressin Challenge Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Infusion
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BT200 36.0mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BT200 48.0 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
BT200 18.0 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BT200 24mg IV Infusion
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BT200 0.18mg
n=6 participants at risk
Subjects will receive a single subcutaneous dose of BT200 0.18mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 0.6mg
n=6 participants at risk
Subjects will receive a single subcutaneous dose of BT200 0.6mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 1.8mg
n=6 participants at risk
Subjects will receive a single subcutaneous dose of BT200 1.8mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 6.0mg
n=6 participants at risk
Subjects will receive a single subcutaneous dose of BT200 6.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 12.0mg
n=6 participants at risk
Subjects will receive a single subcutaneous dose of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24.0mg
n=6 participants at risk
Subjects will receive a single subcutaneous dose of BT200 24.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24.0mg Rep
n=6 participants at risk
Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
Placebo SAD
n=20 participants at risk
Subjects will receive a single subcutaneous dose of placebo
Placebo: Sterile saline for injection
|
BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg
n=6 participants at risk
Subjects will receive an initial subcutaneous loading doses of BT200 12.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg
n=6 participants at risk
Subjects will receive an initial subcutaneous loading dose of BT200 24mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
Placebo MAD
n=4 participants at risk
Subjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo
Placebo: Sterile saline for injection
|
BT200 48.0mg + Desmopressin Challenge
n=6 participants at risk
Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection
|
Placebo + Desmopressin Challenge Dose
n=2 participants at risk
Subjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection
|
Placebo Infusion
n=2 participants at risk
Subjects will receive a single IV dose of placebo administered over 24 hours
Placebo: Sterile saline for injection
|
BT200 36.0mg
n=6 participants at risk
Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 48.0 mg
n=6 participants at risk
Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 18.0 mg
n=6 participants at risk
Subjects will receive a single subcutaneous dose of BT200 18.o mg
|
BT200 24mg IV Infusion
n=6 participants at risk
Subjects will receive a single IV dose of BT200 24mg administered over 24 hours
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
Other adverse events
| Measure |
BT200 0.18mg
n=6 participants at risk
Subjects will receive a single subcutaneous dose of BT200 0.18mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 0.6mg
n=6 participants at risk
Subjects will receive a single subcutaneous dose of BT200 0.6mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 1.8mg
n=6 participants at risk
Subjects will receive a single subcutaneous dose of BT200 1.8mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 6.0mg
n=6 participants at risk
Subjects will receive a single subcutaneous dose of BT200 6.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 12.0mg
n=6 participants at risk
Subjects will receive a single subcutaneous dose of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24.0mg
n=6 participants at risk
Subjects will receive a single subcutaneous dose of BT200 24.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 24.0mg Rep
n=6 participants at risk
Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
Placebo SAD
n=20 participants at risk
Subjects will receive a single subcutaneous dose of placebo
Placebo: Sterile saline for injection
|
BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg
n=6 participants at risk
Subjects will receive an initial subcutaneous loading doses of BT200 12.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg
n=6 participants at risk
Subjects will receive an initial subcutaneous loading dose of BT200 24mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
Placebo MAD
n=4 participants at risk
Subjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo
Placebo: Sterile saline for injection
|
BT200 48.0mg + Desmopressin Challenge
n=6 participants at risk
Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection
|
Placebo + Desmopressin Challenge Dose
n=2 participants at risk
Subjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection
|
Placebo Infusion
n=2 participants at risk
Subjects will receive a single IV dose of placebo administered over 24 hours
Placebo: Sterile saline for injection
|
BT200 36.0mg
n=6 participants at risk
Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 48.0 mg
n=6 participants at risk
Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
|
BT200 18.0 mg
n=6 participants at risk
Subjects will receive a single subcutaneous dose of BT200 18.o mg
|
BT200 24mg IV Infusion
n=6 participants at risk
Subjects will receive a single IV dose of BT200 24mg administered over 24 hours
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Vascular disorders
Thrombosis
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
50.0%
3/6 • Number of events 3 • Adverse events were collected from time of screening up to 56 days post dose
|
25.0%
5/20 • Number of events 6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
50.0%
3/6 • Number of events 4 • Adverse events were collected from time of screening up to 56 days post dose
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Infections and infestations
Root canal infection
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Number of events 6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
30.0%
6/20 • Number of events 7 • Adverse events were collected from time of screening up to 56 days post dose
|
66.7%
4/6 • Number of events 10 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
66.7%
4/6 • Number of events 5 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
50.0%
3/6 • Number of events 3 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
25.0%
1/4 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Gastrointestinal disorders
Abdominal pain uppe
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
33.3%
2/6 • Number of events 4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
General disorders
Axillary pain
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
General disorders
Swelling
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
General disorders
Vessel puncture site hematoma
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Vascular disorders
Hematoma
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
50.0%
2/4 • Number of events 3 • Adverse events were collected from time of screening up to 56 days post dose
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Skin and subcutaneous tissue disorders
Rash Maculopapular
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Injury, poisoning and procedural complications
Subcutaneous Hematoma
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Investigations
Gammaglutamyltransferase increased
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Investigations
Transaminase increased
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Reproductive system and breast disorders
Gynecomastia
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Nervous system disorders
Parasthesia
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
General disorders
Discomfort
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
General disorders
Fatigue
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
General disorders
Tenderness
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Skin and subcutaneous tissue disorders
Skin discoloration
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/20 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/4 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/2 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
0.00%
0/6 • Adverse events were collected from time of screening up to 56 days post dose
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from time of screening up to 56 days post dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place