Trial Outcomes & Findings for AMG 529 First in Human Study (NCT NCT03170193)
NCT ID: NCT03170193
Last Updated: 2019-07-05
Results Overview
Determination of the severity of adverse events was according to the following: grade 1 = mild (eg, asymptomatic or mild symptoms); grade 2 = moderate (eg, minimal intervention indicated or interferes with activity); grade 3 = severe (eg, medically significant but not immediately life-threatening, prevents daily activity, or requires treatment); grade 4 = life-threatening (ie, refers to an event in which the participant was, in the view of the investigator, at risk of death at the time of the event); and grade 5 = fatal. A serious adverse event was defined as an adverse event that met at least 1 of the following criteria: * fatal * life threatening * required in patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Results posted on
2019-07-05
Participant Flow
This study was conducted at a single center in the United States. Participants were enrolled from 15 May 2017 to 18 September 2017.
Participants were enrolled into one of six dose cohorts. Within each cohort participants were randomized in a ratio of 3:1 to receive AMG 529 or placebo.
Participant milestones
| Measure |
Placebo
Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.
|
AMG 529 21 mg SC
Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
|
AMG 529 70 mg SC
Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 210 mg SC
Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 420 mg SC
Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 700 mg SC
Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 70 mg IV
Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
11
|
5
|
6
|
5
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.
|
AMG 529 21 mg SC
Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
|
AMG 529 70 mg SC
Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 210 mg SC
Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 420 mg SC
Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 700 mg SC
Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 70 mg IV
Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
AMG 529 First in Human Study
Baseline characteristics by cohort
| Measure |
Placebo
n=12 Participants
Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.
|
AMG 529 21 mg SC
n=6 Participants
Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
|
AMG 529 70 mg SC
n=6 Participants
Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 210 mg SC
n=6 Participants
Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 420 mg SC
n=6 Participants
Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 700 mg SC
n=6 Participants
Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 70 mg IV
n=6 Participants
Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
33.5 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
32.3 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
35.0 years
STANDARD_DEVIATION 11.0 • n=21 Participants
|
36.5 years
STANDARD_DEVIATION 9.6 • n=8 Participants
|
34.7 years
STANDARD_DEVIATION 12.7 • n=8 Participants
|
36.1 years
STANDARD_DEVIATION 11.1 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
46 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
42 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
29 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.Population: Randomized participants who received at least 1 dose of AMG 529 or placebo.
Determination of the severity of adverse events was according to the following: grade 1 = mild (eg, asymptomatic or mild symptoms); grade 2 = moderate (eg, minimal intervention indicated or interferes with activity); grade 3 = severe (eg, medically significant but not immediately life-threatening, prevents daily activity, or requires treatment); grade 4 = life-threatening (ie, refers to an event in which the participant was, in the view of the investigator, at risk of death at the time of the event); and grade 5 = fatal. A serious adverse event was defined as an adverse event that met at least 1 of the following criteria: * fatal * life threatening * required in patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.
|
AMG 529 21 mg SC
n=6 Participants
Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
|
AMG 529 70 mg SC
n=6 Participants
Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 210 mg SC
n=6 Participants
Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 420 mg SC
n=6 Participants
Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 700 mg SC
n=6 Participants
Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 70 mg IV
n=6 Participants
Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
All adverse events
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs)
Adverse events Grade ≥ 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Adverse events Grade ≥ 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Adverse events Grade ≥ 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
AEs leading to discontinuation of study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Treatment-related adverse events
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs)
Fatal adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.Population: Participants who received AMG 529 for whom at least 1 PK parameter or endpoint was reliably estimated. Four participants were excluded from PK analyses as their profiles had \< 2 samples that were above the lower limit of quantification.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.
|
AMG 529 21 mg SC
n=5 Participants
Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
|
AMG 529 70 mg SC
n=6 Participants
Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 210 mg SC
n=6 Participants
Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 420 mg SC
n=6 Participants
Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 700 mg SC
n=6 Participants
Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 70 mg IV
Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of AMG 529
|
6.90 ng/mL
Standard Deviation 1.73
|
23.8 ng/mL
Standard Deviation 13.4
|
2010 ng/mL
Standard Deviation 3120
|
9370 ng/mL
Standard Deviation 10800
|
35600 ng/mL
Standard Deviation 32700
|
3460 ng/mL
Standard Deviation 4430
|
—
|
SECONDARY outcome
Timeframe: Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.Population: Participants who received AMG 529 for whom at least 1 PK parameter or endpoint was reliably estimated. Four participants were excluded from PK analyses as their profiles had \< 2 samples that were above the lower limit of quantification.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.
|
AMG 529 21 mg SC
n=5 Participants
Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
|
AMG 529 70 mg SC
n=6 Participants
Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 210 mg SC
n=6 Participants
Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 420 mg SC
n=6 Participants
Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 700 mg SC
n=6 Participants
Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 70 mg IV
Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Concentration (Tmax) of AMG 529
|
24 hours
Interval 12.0 to 24.0
|
5.8 hours
Interval 5.8 to 5.8
|
72 hours
Interval 24.0 to 72.0
|
72 hours
Interval 24.0 to 72.0
|
96 hours
Interval 36.0 to 170.0
|
0.5 hours
Interval 0.5 to 0.5
|
—
|
SECONDARY outcome
Timeframe: Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.Population: Participants who received AMG 529 for whom at least 1 PK parameter or endpoint was reliably estimated. Four participants were excluded from PK analyses as their profiles had \< 2 samples that were above the lower limit of quantification.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.
|
AMG 529 21 mg SC
n=5 Participants
Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
|
AMG 529 70 mg SC
n=6 Participants
Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 210 mg SC
n=6 Participants
Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 420 mg SC
n=6 Participants
Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 700 mg SC
n=6 Participants
Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 70 mg IV
Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast) for AMG 529
|
5.99 days*ng/mL
Standard Deviation 2.90
|
46.0 days*ng/mL
Standard Deviation 47.4
|
5370 days*ng/mL
Standard Deviation 8520
|
41800 days*ng/mL
Standard Deviation 51000
|
289000 days*ng/mL
Standard Deviation 330000
|
766 days*ng/mL
Standard Deviation 1240
|
—
|
SECONDARY outcome
Timeframe: Baseline and days 3, 8, and 30Population: Participants who received at least 1 dose of study drug and with available data at each time point
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.
|
AMG 529 21 mg SC
n=6 Participants
Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
|
AMG 529 70 mg SC
n=6 Participants
Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 210 mg SC
n=6 Participants
Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 420 mg SC
n=6 Participants
Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 700 mg SC
n=6 Participants
Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 70 mg IV
n=6 Participants
Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Blood Alkaline Phosphatase Concentration Over Time
Baseline
|
62.0 units/liter
Standard Deviation 13.8
|
69.0 units/liter
Standard Deviation 21.2
|
56.0 units/liter
Standard Deviation 10.8
|
68.0 units/liter
Standard Deviation 12.2
|
57.7 units/liter
Standard Deviation 9.0
|
57.5 units/liter
Standard Deviation 18.0
|
58.0 units/liter
Standard Deviation 8.1
|
|
Change From Baseline in Blood Alkaline Phosphatase Concentration Over Time
Change from baseline to day 3
|
-0.3 units/liter
Standard Deviation 4.2
|
4.7 units/liter
Standard Deviation 4.7
|
7.0 units/liter
Standard Deviation 7.0
|
57.0 units/liter
Standard Deviation 51.7
|
76.7 units/liter
Standard Deviation 76.9
|
88.2 units/liter
Standard Deviation 33.5
|
28.7 units/liter
Standard Deviation 14.7
|
|
Change From Baseline in Blood Alkaline Phosphatase Concentration Over Time
Change from baseline to day 8
|
2.3 units/liter
Standard Deviation 6.0
|
3.2 units/liter
Standard Deviation 7.5
|
17.0 units/liter
Standard Deviation 10.4
|
102.6 units/liter
Standard Deviation 70.8
|
199.3 units/liter
Standard Deviation 256.1
|
155.8 units/liter
Standard Deviation 34.8
|
8.8 units/liter
Standard Deviation 5.8
|
|
Change From Baseline in Blood Alkaline Phosphatase Concentration Over Time
Change from baseline to day 30
|
3.5 units/liter
Standard Deviation 8.5
|
-1.4 units/liter
Standard Deviation 4.0
|
1.8 units/liter
Standard Deviation 5.3
|
-0.8 units/liter
Standard Deviation 4.0
|
11.8 units/liter
Standard Deviation 5.9
|
14.6 units/liter
Standard Deviation 6.5
|
2.0 units/liter
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.Population: Randomized participants who received study drug with available data at each time point.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.
|
AMG 529 21 mg SC
n=6 Participants
Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
|
AMG 529 70 mg SC
n=6 Participants
Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 210 mg SC
n=6 Participants
Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 420 mg SC
n=6 Participants
Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 700 mg SC
n=6 Participants
Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 70 mg IV
n=6 Participants
Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Total Cholesterol Concentration Over Time
Baseline
|
4.5817 mmol/L
Standard Deviation 0.8204
|
5.3567 mmol/L
Standard Deviation 0.9662
|
4.8383 mmol/L
Standard Deviation 1.0789
|
5.3417 mmol/L
Standard Deviation 0.9771
|
4.2483 mmol/L
Standard Deviation 0.6335
|
4.8533 mmol/L
Standard Deviation 0.8125
|
5.0633 mmol/L
Standard Deviation 1.5937
|
|
Change From Baseline in Total Cholesterol Concentration Over Time
Change from baseline to day 3
|
0.0692 mmol/L
Standard Deviation 0.2381
|
-0.1583 mmol/L
Standard Deviation 0.1347
|
-0.0200 mmol/L
Standard Deviation 0.2254
|
0.0800 mmol/L
Standard Deviation 0.2224
|
0.1617 mmol/L
Standard Deviation 0.2375
|
0.2350 mmol/L
Standard Deviation 0.1299
|
0.3400 mmol/L
Standard Deviation 0.3428
|
|
Change From Baseline in Total Cholesterol Concentration Over Time
Change from baseline to day 6
|
0.0867 mmol/L
Standard Deviation 0.4151
|
-0.3317 mmol/L
Standard Deviation 0.1997
|
-0.3533 mmol/L
Standard Deviation 0.3426
|
-0.2520 mmol/L
Standard Deviation 0.6208
|
-0.3267 mmol/L
Standard Deviation 0.3140
|
-0.1667 mmol/L
Standard Deviation 0.2614
|
0.3350 mmol/L
Standard Deviation 0.5461
|
|
Change From Baseline in Total Cholesterol Concentration Over Time
Change from baseline to day 11
|
-0.4625 mmol/L
Standard Deviation 0.4110
|
-1.0620 mmol/L
Standard Deviation 0.5976
|
-0.6933 mmol/L
Standard Deviation 0.4763
|
-0.6700 mmol/L
Standard Deviation 0.5770
|
-0.8500 mmol/L
Standard Deviation 0.6339
|
-0.7600 mmol/L
Standard Deviation 0.5306
|
-0.0340 mmol/L
Standard Deviation 0.8344
|
|
Change From Baseline in Total Cholesterol Concentration Over Time
Change from baseline to day 22
|
-0.0300 mmol/L
Standard Deviation 0.5567
|
-0.7480 mmol/L
Standard Deviation 0.8825
|
-0.2550 mmol/L
Standard Deviation 0.5021
|
-0.1640 mmol/L
Standard Deviation 0.3092
|
-0.2183 mmol/L
Standard Deviation 0.4100
|
-0.2040 mmol/L
Standard Deviation 0.5358
|
-0.3200 mmol/L
Standard Deviation 0.9193
|
|
Change From Baseline in Total Cholesterol Concentration Over Time
Change from baseline to day 30
|
-0.0936 mmol/L
Standard Deviation 0.7880
|
-0.6780 mmol/L
Standard Deviation 0.3467
|
-0.1933 mmol/L
Standard Deviation 0.4376
|
0.1300 mmol/L
Standard Deviation 0.0919
|
0.2583 mmol/L
Standard Deviation 0.4088
|
0.1380 mmol/L
Standard Deviation 0.4964
|
-0.1140 mmol/L
Standard Deviation 0.9209
|
|
Change From Baseline in Total Cholesterol Concentration Over Time
Change from baseline to day 57
|
0.1840 mmol/L
Standard Deviation 0.7451
|
—
|
—
|
0.5120 mmol/L
Standard Deviation 0.8889
|
0.2383 mmol/L
Standard Deviation 0.4896
|
-0.0033 mmol/L
Standard Deviation 0.9705
|
—
|
SECONDARY outcome
Timeframe: Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.Population: Randomized participants who received study drug with available data at each time point.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.
|
AMG 529 21 mg SC
n=6 Participants
Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
|
AMG 529 70 mg SC
n=6 Participants
Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 210 mg SC
n=6 Participants
Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 420 mg SC
n=6 Participants
Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 700 mg SC
n=6 Participants
Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 70 mg IV
n=6 Participants
Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time
Baseline
|
2.8317 mmol/L
Standard Deviation 0.8071
|
3.2683 mmol/L
Standard Deviation 1.0026
|
2.8400 mmol/L
Standard Deviation 0.7687
|
3.4017 mmol/L
Standard Deviation 1.2875
|
2.4633 mmol/L
Standard Deviation 0.5727
|
3.2267 mmol/L
Standard Deviation 0.7112
|
3.1583 mmol/L
Standard Deviation 1.1382
|
|
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time
Change from baseline to day 3
|
0.1608 mmol/L
Standard Deviation 0.2423
|
0.1383 mmol/L
Standard Deviation 0.3271
|
0.2150 mmol/L
Standard Deviation 0.1571
|
-0.0867 mmol/L
Standard Deviation 0.3280
|
0.2650 mmol/L
Standard Deviation 0.1401
|
0.3350 mmol/L
Standard Deviation 0.2482
|
0.3350 mmol/L
Standard Deviation 0.2874
|
|
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time
Change from baseline to day 6
|
0.1400 mmol/L
Standard Deviation 0.2992
|
0.0417 mmol/L
Standard Deviation 0.3547
|
0.1050 mmol/L
Standard Deviation 0.1549
|
-0.5860 mmol/L
Standard Deviation 0.5180
|
-0.0967 mmol/L
Standard Deviation 0.2708
|
-0.0967 mmol/L
Standard Deviation 0.1975
|
0.1650 mmol/L
Standard Deviation 0.5853
|
|
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time
Change from baseline to day 11
|
-0.3367 mmol/L
Standard Deviation 0.4298
|
-0.7600 mmol/L
Standard Deviation 0.4464
|
-0.3900 mmol/L
Standard Deviation 0.2912
|
-0.7920 mmol/L
Standard Deviation 0.4873
|
-0.7333 mmol/L
Standard Deviation 0.5000
|
-0.5850 mmol/L
Standard Deviation 0.2204
|
-0.0520 mmol/L
Standard Deviation 0.5955
|
|
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time
Change from baseline to day 22
|
0.0117 mmol/L
Standard Deviation 0.4577
|
-0.5240 mmol/L
Standard Deviation 0.8043
|
-0.0600 mmol/L
Standard Deviation 0.3205
|
-0.2860 mmol/L
Standard Deviation 0.4116
|
-0.3517 mmol/L
Standard Deviation 0.3969
|
-0.3960 mmol/L
Standard Deviation 0.1521
|
-0.2780 mmol/L
Standard Deviation 0.7706
|
|
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time
Change from baseline to day 30
|
-0.1018 mmol/L
Standard Deviation 0.6698
|
-0.4260 mmol/L
Standard Deviation 0.4258
|
-0.0767 mmol/L
Standard Deviation 0.4002
|
-0.4020 mmol/L
Standard Deviation 0.4773
|
0.2667 mmol/L
Standard Deviation 0.3768
|
-0.0740 mmol/L
Standard Deviation 0.4999
|
-0.2680 mmol/L
Standard Deviation 0.9091
|
|
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time
Change from baseline to day 57
|
0.0500 mmol/L
Standard Deviation 0.7559
|
—
|
—
|
0.0520 mmol/L
Standard Deviation 0.6514
|
0.1283 mmol/L
Standard Deviation 0.3075
|
-0.1617 mmol/L
Standard Deviation 0.8583
|
—
|
SECONDARY outcome
Timeframe: Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.Population: Randomized participants who received study drug with available data at each time point.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.
|
AMG 529 21 mg SC
n=6 Participants
Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
|
AMG 529 70 mg SC
n=6 Participants
Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 210 mg SC
n=6 Participants
Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 420 mg SC
n=6 Participants
Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 700 mg SC
n=6 Participants
Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 70 mg IV
n=6 Participants
Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time
Baseline
|
1.1775 mmol/L
Standard Deviation 0.2932
|
1.3783 mmol/L
Standard Deviation 0.2928
|
1.3950 mmol/L
Standard Deviation 0.2626
|
1.4133 mmol/L
Standard Deviation 0.4968
|
1.2633 mmol/L
Standard Deviation 0.2202
|
1.0700 mmol/L
Standard Deviation 0.4527
|
1.4417 mmol/L
Standard Deviation 0.5517
|
|
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time
Change from baseline to day 3
|
-0.0592 mmol/L
Standard Deviation 0.1094
|
-0.0100 mmol/L
Standard Deviation 0.1092
|
-0.1267 mmol/L
Standard Deviation 0.0935
|
0.0417 mmol/L
Standard Deviation 0.1032
|
-0.0600 mmol/L
Standard Deviation 0.1373
|
0.0783 mmol/L
Standard Deviation 0.0981
|
-0.0383 mmol/L
Standard Deviation 0.1118
|
|
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time
Change from baseline to day 6
|
-0.0975 mmol/L
Standard Deviation 0.1096
|
-0.1617 mmol/L
Standard Deviation 0.1254
|
-0.2083 mmol/L
Standard Deviation 0.1430
|
-0.0980 mmol/L
Standard Deviation 0.1417
|
-0.1100 mmol/L
Standard Deviation 0.2028
|
0.0350 mmol/L
Standard Deviation 0.1816
|
-0.0767 mmol/L
Standard Deviation 0.1402
|
|
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time
Change from baseline to day 11
|
-0.0133 mmol/L
Standard Deviation 0.1224
|
-0.2080 mmol/L
Standard Deviation 0.1854
|
-0.1600 mmol/L
Standard Deviation 0.1689
|
-0.0960 mmol/L
Standard Deviation 0.1318
|
-0.0800 mmol/L
Standard Deviation 0.0812
|
0.0475 mmol/L
Standard Deviation 0.0768
|
-0.0060 mmol/L
Standard Deviation 0.1809
|
|
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time
Change from baseline to day 22
|
0.0208 mmol/L
Standard Deviation 0.1468
|
-0.0580 mmol/L
Standard Deviation 0.1644
|
-0.0417 mmol/L
Standard Deviation 0.1815
|
0.0220 mmol/L
Standard Deviation 0.1026
|
0.0583 mmol/L
Standard Deviation 0.1533
|
0.2860 mmol/L
Standard Deviation 0.1704
|
0.0320 mmol/L
Standard Deviation 0.1583
|
|
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time
Change from baseline to day 30
|
0.0473 mmol/L
Standard Deviation 0.1769
|
-0.0760 mmol/L
Standard Deviation 0.0853
|
-0.0400 mmol/L
Standard Deviation 0.3107
|
0.1380 mmol/L
Standard Deviation 0.1644
|
0.0667 mmol/L
Standard Deviation 0.2060
|
0.2480 mmol/L
Standard Deviation 0.0944
|
0.1340 mmol/L
Standard Deviation 0.1396
|
|
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time
Change from baseline to day 57
|
-0.0540 mmol/L
Standard Deviation 0.1549
|
—
|
—
|
0.1160 mmol/L
Standard Deviation 0.1595
|
0.1483 mmol/L
Standard Deviation 0.1113
|
0.2633 mmol/L
Standard Deviation 0.2470
|
—
|
SECONDARY outcome
Timeframe: Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.Population: Randomized participants who received study drug with available data at each time point.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.
|
AMG 529 21 mg SC
n=6 Participants
Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
|
AMG 529 70 mg SC
n=6 Participants
Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 210 mg SC
n=6 Participants
Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 420 mg SC
n=6 Participants
Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 700 mg SC
n=6 Participants
Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 70 mg IV
n=6 Participants
Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Triglycerides Concentration Over Time
Change from baseline to day 6
|
-0.0525 mmol/L
Standard Deviation 0.3015
|
-0.0450 mmol/L
Standard Deviation 0.1148
|
-0.0583 mmol/L
Standard Deviation 0.1932
|
0.4580 mmol/L
Standard Deviation 1.2469
|
-0.2900 mmol/L
Standard Deviation 0.2521
|
-0.5783 mmol/L
Standard Deviation 0.5958
|
0.3133 mmol/L
Standard Deviation 0.3102
|
|
Change From Baseline in Triglycerides Concentration Over Time
Baseline
|
1.2292 mmol/L
Standard Deviation 0.5080
|
1.1100 mmol/L
Standard Deviation 0.5588
|
1.0050 mmol/L
Standard Deviation 0.5478
|
1.3750 mmol/L
Standard Deviation 0.9770
|
1.0533 mmol/L
Standard Deviation 0.3525
|
1.5067 mmol/L
Standard Deviation 1.0848
|
0.8317 mmol/L
Standard Deviation 0.3036
|
|
Change From Baseline in Triglycerides Concentration Over Time
Change from baseline to day 3
|
-0.0942 mmol/L
Standard Deviation 0.2880
|
-0.1283 mmol/L
Standard Deviation 0.1379
|
-0.0633 mmol/L
Standard Deviation 0.2366
|
-0.0183 mmol/L
Standard Deviation 0.3725
|
-0.1833 mmol/L
Standard Deviation 0.0993
|
-0.5600 mmol/L
Standard Deviation 0.6615
|
0.0750 mmol/L
Standard Deviation 0.1244
|
|
Change From Baseline in Triglycerides Concentration Over Time
Change from baseline to day 11
|
-0.0975 mmol/L
Standard Deviation 0.3470
|
0.2040 mmol/L
Standard Deviation 0.7577
|
0.1400 mmol/L
Standard Deviation 0.4963
|
0.1840 mmol/L
Standard Deviation 0.4797
|
-0.1167 mmol/L
Standard Deviation 0.4131
|
-0.5925 mmol/L
Standard Deviation 1.0357
|
0.3320 mmol/L
Standard Deviation 0.5496
|
|
Change From Baseline in Triglycerides Concentration Over Time
Change from baseline to day 22
|
0.0475 mmol/L
Standard Deviation 0.5965
|
0.0920 mmol/L
Standard Deviation 0.2212
|
0.5800 mmol/L
Standard Deviation 0.6549
|
0.1780 mmol/L
Standard Deviation 0.4043
|
0.2183 mmol/L
Standard Deviation 0.2193
|
-0.4360 mmol/L
Standard Deviation 0.9239
|
0.3340 mmol/L
Standard Deviation 0.4185
|
|
Change From Baseline in Triglycerides Concentration Over Time
Change from baseline to day 30
|
0.0991 mmol/L
Standard Deviation 0.4538
|
0.2320 mmol/L
Standard Deviation 0.3214
|
0.5533 mmol/L
Standard Deviation 0.7672
|
0.2600 mmol/L
Standard Deviation 0.5742
|
0.0533 mmol/L
Standard Deviation 0.4320
|
-0.0360 mmol/L
Standard Deviation 0.5330
|
0.2220 mmol/L
Standard Deviation 0.1580
|
|
Change From Baseline in Triglycerides Concentration Over Time
Change from baseline to day 57
|
0.4580 mmol/L
Standard Deviation 0.5334
|
—
|
—
|
0.4900 mmol/L
Standard Deviation 0.7883
|
0.0533 mmol/L
Standard Deviation 0.3663
|
-0.3283 mmol/L
Standard Deviation 0.5669
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AMG 529 21 mg SC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AMG 529 70 mg SC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AMG 529 210 mg SC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
AMG 529 420 mg SC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
AMG 529 700 mg SC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AMG 529 70 mg IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=12 participants at risk
Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.
|
AMG 529 21 mg SC
n=6 participants at risk
Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
|
AMG 529 70 mg SC
n=6 participants at risk
Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 210 mg SC
n=6 participants at risk
Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 420 mg SC
n=6 participants at risk
Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 700 mg SC
n=6 participants at risk
Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
|
AMG 529 70 mg IV
n=6 participants at risk
Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/12 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/12 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatine phosphokinase increased
|
8.3%
1/12 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/12 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
White blood cell count increased
|
0.00%
0/12 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/12 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
8.3%
1/12 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER