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A study to assess the safety and tolerability of AMG 529 following single, ascending doses administered subcutaneously (SC) or intravenously (IV) in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 529 | Experimental | Participants received a single dose of AMG 529 at ascending dose levels by either subcutaneous or intravenous injection. |
|
| Placebo | Placebo Comparator | Participants received a single dose of placebo matching to AMG 529 by either subcutaneous or intravenous injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 529 | Drug | Ascending single doses of AMG 529 by subcutaneous (SC) or intravenous (IV) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 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:
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of AMG 529 | 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. | |
| Time to Maximum Observed Concentration (Tmax) of AMG 529 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | 66212 | United States |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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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.
This study was conducted at a single center in the United States. Participants were enrolled from 15 May 2017 to 18 September 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received a single dose of matching placebo by either subcutaneous or intravenous injection. |
| FG001 | AMG 529 21 mg SC | Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection. |
| FG002 | AMG 529 70 mg SC | Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection. |
| FG003 | AMG 529 210 mg SC | Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection. |
| FG004 | AMG 529 420 mg SC | Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection. |
| FG005 | AMG 529 700 mg SC | Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection. |
| FG006 | AMG 529 70 mg IV | Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received a single dose of matching placebo by either subcutaneous or intravenous injection. |
| BG001 | AMG 529 21 mg SC | Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Participants With Adverse Events (AEs) | 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:
| Randomized participants who received at least 1 dose of AMG 529 or placebo. | Posted | Count of Participants | Participants | 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. |
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.
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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 | Placebo | Participants received a single dose of matching placebo by either subcutaneous or intravenous injection. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 20.1 | 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 | May 1, 2017 | Apr 12, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 20, 2017 | Apr 12, 2019 | SAP_001.pdf |
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Within each dose cohort participants were randomized in a 3:1 ratio to receive either AMG 529 or placebo.
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| Placebo | Drug | Single doses of matching placebo by SC or IV injection |
|
| 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. |
| Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast) for AMG 529 | 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. |
| Change From Baseline in Blood Alkaline Phosphatase Concentration Over Time | Baseline and days 3, 8, and 30 |
| Change From Baseline in Total Cholesterol Concentration Over Time | 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. |
| Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time | 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. |
| Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time | 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. |
| Change From Baseline in Triglycerides Concentration Over Time | 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. |
| Lost to Follow-up |
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| BG002 | AMG 529 70 mg SC | Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection. |
| BG003 | AMG 529 210 mg SC | Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection. |
| BG004 | AMG 529 420 mg SC | Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection. |
| BG005 | AMG 529 700 mg SC | Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection. |
| BG006 | AMG 529 70 mg IV | Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection. |
| BG007 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of matching placebo by either subcutaneous or intravenous injection. |
| OG001 | AMG 529 21 mg SC | Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection. |
| OG002 | AMG 529 70 mg SC | Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection. |
| OG003 | AMG 529 210 mg SC | Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection. |
| OG004 | AMG 529 420 mg SC | Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection. |
| OG005 | AMG 529 700 mg SC | Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection. |
| OG006 | AMG 529 70 mg IV | Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection. |
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| Secondary | Maximum Observed Concentration (Cmax) of AMG 529 | 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. | Posted | Mean | Standard Deviation | ng/mL | 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. |
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| Secondary | Time to Maximum Observed Concentration (Tmax) of AMG 529 | 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. | Posted | Median | Full Range | hours | 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. |
|
|
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| Secondary | Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast) for AMG 529 | 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. | Posted | Mean | Standard Deviation | days*ng/mL | 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. |
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| Secondary | Change From Baseline in Blood Alkaline Phosphatase Concentration Over Time | Participants who received at least 1 dose of study drug and with available data at each time point | Posted | Mean | Standard Deviation | units/liter | Baseline and days 3, 8, and 30 |
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| Secondary | Change From Baseline in Total Cholesterol Concentration Over Time | Randomized participants who received study drug with available data at each time point. | Posted | Mean | Standard Deviation | mmol/L | 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. |
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| Secondary | Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time | Randomized participants who received study drug with available data at each time point. | Posted | Mean | Standard Deviation | mmol/L | 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. |
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| Secondary | Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time | Randomized participants who received study drug with available data at each time point. | Posted | Mean | Standard Deviation | mmol/L | 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. |
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| Secondary | Change From Baseline in Triglycerides Concentration Over Time | Randomized participants who received study drug with available data at each time point. | Posted | Mean | Standard Deviation | mmol/L | 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. |
|
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| 0 |
| 12 |
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | AMG 529 21 mg SC | Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | AMG 529 70 mg SC | Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | AMG 529 210 mg SC | Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG004 | AMG 529 420 mg SC | Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG005 | AMG 529 700 mg SC | Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG006 | AMG 529 70 mg IV | Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection. | 0 | 6 | 0 | 6 | 2 | 6 |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Neutrophil count increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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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.
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