- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02618967
Single Ascending Dose Study of AMG 570 in Healthy Subjects
A Randomized, Double Blind Placebo Controlled, First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of AMG 570 in Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Indiana
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Evansville, Indiana, United States, 47710
- Research Site
-
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Kansas
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Overland Park, Kansas, United States, 66212
- Research Site
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Wisconsin
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Madison, Wisconsin, United States, 53704
- Research Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy as determined by the investigator
- Normal or clinically acceptable electrocardiogram (ECG)
- Female subjects must be of documented non-reproductive potential
- Subjects must be current for all vaccinations
- Other inclusion criteria may apply
Exclusion Criteria:
- Current or chronic history of liver disease
- History of active infections
- History of significant respiratory disorder
- Evidence of renal disease
- Other exclusion criteria may apply
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AMG 570 - 7 mg
Participants will receive a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers.
Other Names:
|
Experimental: AMG 570 - 21 mg
Participants will receive a single 21 mg dose of AMG 570 administered subcutaneously.
|
7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers.
Other Names:
|
Experimental: AMG 570 - 70 mg
Participants will receive a single 70 mg dose of AMG 570 administered subcutaneously.
|
7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers.
Other Names:
|
Experimental: AMG 570 - 140 mg
Participants will receive a single 140 mg dose of AMG 570 administered subcutaneously.
|
7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers.
Other Names:
|
Experimental: AMG 570 - 210 mg
Participants will receive a single 210 mg dose of AMG 570 administered subcutaneously.
|
7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers.
Other Names:
|
Experimental: AMG 570 - 420 mg
Participants will receive a single 420 mg dose of AMG 570 administered subcutaneously.
|
7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers.
Other Names:
|
Experimental: AMG 570 - 700 mg
Participants will receive a single 700 mg dose of AMG 570 administered subcutaneously.
|
7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers.
Other Names:
|
Placebo Comparator: Placebo
Participants will receive a single dose of the matching AMG 570 placebo administered subcutaneously.
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Placebo administered as single dose subcutaneous in healthy volunteers.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)
Time Frame: Day 1 to Day 105
|
TEAEs were adverse events with an onset after the administration of study treatment. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated. Serious adverse events (SAEs) were defined as meeting at least 1 of the following criteria:
|
Day 1 to Day 105
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Number of Participants Who Experienced a Clinically Significant Change in Physical Examinations
Time Frame: Baseline to Day 105
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Physical examinations were performed by the investigator, designated physician, or nurse practitioner.
A complete physical examination included, at a minimum, assessment of cardiovascular, respiratory, gastrointestinal and neurological systems.
A brief physical examination included assessment of the skin, lungs, cardiovascular system, and abdomen (liver and spleen).
|
Baseline to Day 105
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Number of Participants Who Experienced a Clinically Significant Change in Vital Signs
Time Frame: Baseline to Day 105
|
Any changes in blood pressure, body temperature, heart rate, and pulse rate that were deemed as clinically significant by the Investigator were reported.
|
Baseline to Day 105
|
Number of Participants Who Experienced a Clinically Significant Change in Clinical Laboratory Safety Tests
Time Frame: Baseline to Day 105
|
Laboratory safety tests included chemistry, hematology, and urinalysis parameters. Clinically significant laboratory safety tests were any events assessed as CTCAE Grade ≥3 at any post-baseline visit. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated. |
Baseline to Day 105
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Number of Participants Who Experienced a Clinically Significant Change in Electrocardiograms (ECGs)
Time Frame: Baseline to Day 105
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Any changes in ECG parameters that were deemed clinically significant by the Investigator were reported.
|
Baseline to Day 105
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Concentration (Cmax) of AMG 570
Time Frame: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
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AMG 570 pharmacokinetic (PK) parameters were estimated using non-compartmental analysis.
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Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
|
Time to Reach Maximum Observed Concentration (Tmax) of AMG 570
Time Frame: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
|
AMG 570 PK parameters were estimated using non-compartmental analysis.
|
Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
|
Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of AMG 570
Time Frame: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
|
AMG 570 PK parameters were estimated using non-compartmental analysis.
|
Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
|
Area Under the Concentration-time Curve Observed From Time Zero to Infinity (AUCinf) of AMG 570
Time Frame: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
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Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
|
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Number of Participants With an Anti-AMG 570 Binding Antibody Positive Postbaseline Result
Time Frame: Baseline to Day 105
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The presence of anti-AMG 570 binding antibodies was assessed using a validated assay.
The number and percentage of participants who developed binding anti-AMG 570 antibodies at any postbaseline visit are presented.
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Baseline to Day 105
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Mean Peripheral Blood B7-Related Protein-1 (B7RP-1) Receptor Occupancy on Total B Cells
Time Frame: Day 8; Day 29; Day 57; and Day 105
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Peripheral B7RP1 (also known as inducible costimulator ligand [ICOSL]) receptor occupancy was calculated from the free ICOSL and total ICOSL measurement from B cells in whole blood.
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Day 8; Day 29; Day 57; and Day 105
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Percentage Change From Baseline for Cluster of Differentiation (CD)19+ Total B Cells Counts
Time Frame: Baseline to Day 8; Day 29; Day 57 and Day 105
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Baseline to Day 8; Day 29; Day 57 and Day 105
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Percentage Change From Baseline for CD19+ Total B Cells Percentages (%)
Time Frame: Baseline to Day 8; Day 29; Day 57 and Day 105
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Baseline to Day 8; Day 29; Day 57 and Day 105
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: MD, Amgen
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20140322
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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