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The primary objective of this study is to evaluate the pharmacokinetics (PK) of AMG 133 after single subcutaneous (SC) administration in healthy Japanese and Caucasian participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Japanese Participants: AMG 133 Low Dose | Experimental | Healthy Japanese participants will receive the low dose of AMG 133 as a SC injection on Day 1 of the study. |
|
| Japanese Participants: AMG 133 Medium Dose | Experimental | Healthy Japanese participants will receive the medium dose of AMG 133 as a SC injection on Day 1 of the study. |
|
| Japanese Participants: AMG 133 High Dose | Experimental | Healthy Japanese participants will receive the high dose of AMG 133 as a SC injection on Day 1 of the study. |
|
| Caucasian Participants: AMG 133 Medium Dose | Experimental | Healthy Caucasian participants will receive the medium dose of AMG 133 as a SC injection on Day 1 of the study. |
|
| Caucasian Participants: AMG 133 High Dose | Experimental | Healthy Caucasian participants will receive the high dose of AMG 133 as a SC injection on Day 1 of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 133 | Drug | Solution for SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133 | 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. | Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose |
| Cmax of Total AMG 133 | 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. | Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose |
| Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Intact AMG 133 | 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. | Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose |
| AUClast of Total AMG 133 | 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. | Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose |
| Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Intact AMG 133 | 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. | Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT Global LLC | Cypress | California | 90630-4738 | United States |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
A total of 34 participants were enrolled and randomized in the study. All 34 participants were dosed in accordance with the protocol.
Healthy Japanese and Caucasian participants were enrolled at a single center in the United States between 10 September 2021 and 08 April 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population: Included all participants who received at least 1 dose of AMG 133.
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| ID | Title | Description |
|---|---|---|
| BG000 | Japanese Participants: AMG 133 Low Dose | Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study. |
| BG001 | Japanese Participants: AMG 133 Medium Dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133 | 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. | Pharmacokinetic (PK) Population: Included all participants who received at least 1 dose of AMG 133 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Japanese Participants: AMG 133 Low Dose | Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 24, 2021 | Feb 4, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 18, 2021 | Feb 4, 2025 | SAP_001.pdf |
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|
| AUCinf of Total AMG 133 | 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. | Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose |
| Day 1 to Day 120 |
| Number of Participants With a Positive Anti-AMG 133 Binding Antibody Result | 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. | Days 1, 15, 29, 57 and 120 |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study.
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| Primary | Cmax of Total AMG 133 | 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. | PK Population: Included all participants who received at least 1 dose of AMG 133 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose |
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Intact AMG 133 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose |
|
|
|
| Primary | AUClast of Total AMG 133 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose |
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Intact AMG 133 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose |
|
|
|
| Primary | AUCinf of Total AMG 133 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose |
|
|
|
| Secondary | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | 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. | Safety Population: Included all participants who received at least 1 dose of AMG 133. | Posted | Count of Participants | Participants | Day 1 to Day 120 |
|
|
|
| Secondary | Number of Participants With a Positive Anti-AMG 133 Binding Antibody Result | 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. | Safety Population: Included all participants who received at least 1 dose of AMG 133. | Posted | Count of Participants | Participants | Days 1, 15, 29, 57 and 120 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | 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. | 0 | 7 | 0 | 7 | 6 | 7 |
| EG002 | 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. | 0 | 7 | 1 | 7 | 7 | 7 |
| EG003 | 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. | 0 | 7 | 0 | 7 | 7 | 7 |
| EG004 | 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. | 0 | 7 | 0 | 7 | 7 | 7 |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Bowel movement irregularity | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Asymptomatic COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Pancreatic enzymes increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| SARS-CoV-2 test positive | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
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.