Trial Outcomes & Findings for Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants (NCT NCT05056246)
NCT ID: NCT05056246
Last Updated: 2025-02-25
Results Overview
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Results posted on
2025-02-25
Participant Flow
Healthy Japanese and Caucasian participants were enrolled at a single center in the United States between 10 September 2021 and 08 April 2022.
A total of 34 participants were enrolled and randomized in the study. All 34 participants were dosed in accordance with the protocol.
Participant milestones
| Measure |
Japanese Participants: AMG 133 Low Dose
Healthy Japanese participants received the low dose of AMG 133 as a subcutaneous (SC) injection on Day 1 of the study.
|
Japanese Participants: AMG 133 Medium Dose
Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 High Dose
Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 Medium Dose
Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 High Dose
Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
7
|
7
|
7
|
|
Overall Study
Received AMG 133
|
6
|
7
|
7
|
7
|
7
|
|
Overall Study
COMPLETED
|
6
|
6
|
7
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Japanese Participants: AMG 133 Low Dose
Healthy Japanese participants received the low dose of AMG 133 as a subcutaneous (SC) injection on Day 1 of the study.
|
Japanese Participants: AMG 133 Medium Dose
Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 High Dose
Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 Medium Dose
Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 High Dose
Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants
Baseline characteristics by cohort
| Measure |
Japanese Participants: AMG 133 Low Dose
n=6 Participants
Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 Medium Dose
n=7 Participants
Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 High Dose
n=7 Participants
Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 Medium Dose
n=7 Participants
Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 High Dose
n=7 Participants
Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 4.80 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 5.35 • n=7 Participants
|
52.9 years
STANDARD_DEVIATION 13.90 • n=5 Participants
|
43.0 years
STANDARD_DEVIATION 14.59 • n=4 Participants
|
49.0 years
STANDARD_DEVIATION 11.93 • n=21 Participants
|
51.3 years
STANDARD_DEVIATION 11.58 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
28 Participants
n=8 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
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dosePopulation: Pharmacokinetic (PK) Population: Included all participants who received at least 1 dose of AMG 133 and had evaluable PK data.
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Outcome measures
| Measure |
Japanese Participants: AMG 133 Low Dose
n=6 Participants
Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 Medium Dose
n=7 Participants
Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 High Dose
n=7 Participants
Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 Medium Dose
n=7 Participants
Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 High Dose
n=6 Participants
Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133
|
12.3 μg/mL
Geometric Coefficient of Variation 57.3
|
22.7 μg/mL
Geometric Coefficient of Variation 24.1
|
44.9 μg/mL
Geometric Coefficient of Variation 34.6
|
22.5 μg/mL
Geometric Coefficient of Variation 33.9
|
55.0 μg/mL
Geometric Coefficient of Variation 26.7
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dosePopulation: PK Population: Included all participants who received at least 1 dose of AMG 133 and had evaluable PK data.
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Outcome measures
| Measure |
Japanese Participants: AMG 133 Low Dose
n=6 Participants
Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 Medium Dose
n=7 Participants
Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 High Dose
n=7 Participants
Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 Medium Dose
n=7 Participants
Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 High Dose
n=6 Participants
Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
|---|---|---|---|---|---|
|
Cmax of Total AMG 133
|
13.2 μg/mL
Geometric Coefficient of Variation 56.3
|
24.8 μg/mL
Geometric Coefficient of Variation 25.6
|
48.4 μg/mL
Geometric Coefficient of Variation 32.0
|
20.8 μg/mL
Geometric Coefficient of Variation 24.5
|
58.7 μg/mL
Geometric Coefficient of Variation 24.8
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dosePopulation: PK Population: Included all participants who received at least 1 dose of AMG 133 and had evaluable PK data. Only participants with available data are included.
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Outcome measures
| Measure |
Japanese Participants: AMG 133 Low Dose
n=6 Participants
Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 Medium Dose
n=6 Participants
Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 High Dose
n=7 Participants
Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 Medium Dose
n=5 Participants
Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 High Dose
n=6 Participants
Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Intact AMG 133
|
10600 h*ug/mL
Geometric Coefficient of Variation 45.2
|
19400 h*ug/mL
Geometric Coefficient of Variation 36.0
|
33500 h*ug/mL
Geometric Coefficient of Variation 20.5
|
17200 h*ug/mL
Geometric Coefficient of Variation 42.4
|
35700 h*ug/mL
Geometric Coefficient of Variation 31.1
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dosePopulation: PK Population: Included all participants who received at least 1 dose of AMG 133 and had evaluable PK data. Only participants with available data are included.
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Outcome measures
| Measure |
Japanese Participants: AMG 133 Low Dose
n=6 Participants
Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 Medium Dose
n=6 Participants
Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 High Dose
n=7 Participants
Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 Medium Dose
n=5 Participants
Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 High Dose
n=6 Participants
Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
|---|---|---|---|---|---|
|
AUClast of Total AMG 133
|
14800 h*ug/mL
Geometric Coefficient of Variation 41.8
|
28300 h*ug/mL
Geometric Coefficient of Variation 37.2
|
47700 h*ug/mL
Geometric Coefficient of Variation 21.1
|
20800 h*ug/mL
Geometric Coefficient of Variation 41.4
|
49600 h*ug/mL
Geometric Coefficient of Variation 30.9
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dosePopulation: PK Population: Included all participants who received at least 1 dose of AMG 133 and had evaluable PK data. Only participants with available data are included.
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Outcome measures
| Measure |
Japanese Participants: AMG 133 Low Dose
n=6 Participants
Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 Medium Dose
n=6 Participants
Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 High Dose
n=7 Participants
Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 Medium Dose
n=5 Participants
Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 High Dose
n=6 Participants
Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Intact AMG 133
|
10700 h*ug/mL
Geometric Coefficient of Variation 44.9
|
19600 h*ug/mL
Geometric Coefficient of Variation 36.4
|
33900 h*ug/mL
Geometric Coefficient of Variation 20.4
|
17300 h*ug/mL
Geometric Coefficient of Variation 43.3
|
36000 h*ug/mL
Geometric Coefficient of Variation 31.6
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dosePopulation: PK Population: Included all participants who received at least 1 dose of AMG 133 and had evaluable PK data. Only participants with available data are included.
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Outcome measures
| Measure |
Japanese Participants: AMG 133 Low Dose
n=6 Participants
Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 Medium Dose
n=6 Participants
Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 High Dose
n=7 Participants
Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 Medium Dose
n=5 Participants
Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 High Dose
n=6 Participants
Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
|---|---|---|---|---|---|
|
AUCinf of Total AMG 133
|
15600 h*ug/mL
Geometric Coefficient of Variation 40.5
|
30100 h*ug/mL
Geometric Coefficient of Variation 39.2
|
50100 h*ug/mL
Geometric Coefficient of Variation 21.8
|
21800 h*ug/mL
Geometric Coefficient of Variation 45.4
|
51500 h*ug/mL
Geometric Coefficient of Variation 32.5
|
SECONDARY outcome
Timeframe: Day 1 to Day 120Population: Safety Population: Included all participants who received at least 1 dose of AMG 133.
A TEAE was defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with AMG 133 that started during or after dosing, or started prior to dosing and increased in severity after dosing. Clinically significant changes from baseline in clinical laboratory tests, 12-lead electrocardiograms (ECGs) and vital signs were also reported as TEAEs.
Outcome measures
| Measure |
Japanese Participants: AMG 133 Low Dose
n=6 Participants
Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 Medium Dose
n=7 Participants
Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 High Dose
n=7 Participants
Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 Medium Dose
n=7 Participants
Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 High Dose
n=7 Participants
Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
|
6 Participants
|
6 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Days 1, 15, 29, 57 and 120Population: Safety Population: Included all participants who received at least 1 dose of AMG 133.
Blood samples were collected at specific times during the study for the measurement of anti-AMG 133 binding antibodies from participants who received AMG 133.
Outcome measures
| Measure |
Japanese Participants: AMG 133 Low Dose
n=6 Participants
Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 Medium Dose
n=7 Participants
Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 High Dose
n=7 Participants
Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 Medium Dose
n=7 Participants
Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 High Dose
n=7 Participants
Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
|---|---|---|---|---|---|
|
Number of Participants With a Positive Anti-AMG 133 Binding Antibody Result
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Japanese Participants: AMG 133 Low Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Japanese Participants: AMG 133 Medium Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Japanese Participants: AMG 133 High Dose
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Caucasian Participants: AMG 133 Medium Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Caucasian Participants: AMG 133 High Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Japanese Participants: AMG 133 Low Dose
n=6 participants at risk
Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 Medium Dose
n=7 participants at risk
Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 High Dose
n=7 participants at risk
Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 Medium Dose
n=7 participants at risk
Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 High Dose
n=7 participants at risk
Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
Other adverse events
| Measure |
Japanese Participants: AMG 133 Low Dose
n=6 participants at risk
Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 Medium Dose
n=7 participants at risk
Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Japanese Participants: AMG 133 High Dose
n=7 participants at risk
Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 Medium Dose
n=7 participants at risk
Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
|
Caucasian Participants: AMG 133 High Dose
n=7 participants at risk
Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
42.9%
3/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Investigations
Amylase increased
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Gastrointestinal disorders
Nausea
|
83.3%
5/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
85.7%
6/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
100.0%
7/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
100.0%
7/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
100.0%
7/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
4/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
85.7%
6/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
100.0%
7/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
100.0%
7/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
100.0%
7/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
General disorders
Chills
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
General disorders
Fatigue
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
28.6%
2/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
General disorders
Pain
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
28.6%
2/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
28.6%
2/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Infections and infestations
Gastroenteritis viral
|
16.7%
1/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
28.6%
2/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
28.6%
2/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
0.00%
0/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
14.3%
1/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
42.9%
3/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
71.4%
5/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
42.9%
3/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
42.9%
3/7 • All-cause mortality was collected from enrolment to end of study (median [min,max]: 4.42 months [1.51, 5.42 months]. Serious adverse events and other adverse events were collected from Day 1 to Day 120.
|
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