Single Ascending Dose Study of AMG 570 in Healthy Subjects

March 1, 2024 updated by: Amgen

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

The purpose of this study is to obtain initial information on the safety and tolerability (effects good or bad), pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of a single dose of AMG 570.

Study Overview

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Indiana
      • Evansville, Indiana, United States, 47710
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Active Comparator, Investigational Product, and Study drug
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:
  • Active Comparator, Investigational Product, and Study drug
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:
  • Active Comparator, Investigational Product, and Study drug
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:
  • Active Comparator, Investigational Product, and Study drug
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:
  • Active Comparator, Investigational Product, and Study drug
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:
  • Active Comparator, Investigational Product, and Study drug
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:
  • Active Comparator, Investigational Product, and Study drug
Placebo Comparator: Placebo
Participants will receive a single dose of the matching AMG 570 placebo administered subcutaneously.
Placebo administered as single dose subcutaneous in healthy volunteers.
Other Names:
  • Placebo, Investigational Product, and Study drug

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:

  • Results in death (fatal)
  • Immediately life-threatening
  • Requires in-patient hospitalization or prolongation of existing hospitalization
  • Results in persistent or significant disability/incapacity
  • Is a congenital anomaly/birth defect
  • Other medically important serious event
Day 1 to Day 105
Number of Participants Who Experienced a Clinically Significant Change in Physical Examinations
Time Frame: Baseline to Day 105
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
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
Number of Participants Who Experienced a Clinically Significant Change in Electrocardiograms (ECGs)
Time Frame: Baseline to Day 105
Any changes in ECG parameters that were deemed clinically significant by the Investigator were reported.
Baseline to Day 105

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
AMG 570 pharmacokinetic (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
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
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
Number of Participants With an Anti-AMG 570 Binding Antibody Positive Postbaseline Result
Time Frame: Baseline to Day 105
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.
Baseline to Day 105
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
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.
Day 8; Day 29; Day 57; and Day 105
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
Baseline to Day 8; Day 29; Day 57 and Day 105
Percentage Change From Baseline for CD19+ Total B Cells Percentages (%)
Time Frame: Baseline to Day 8; Day 29; Day 57 and Day 105
Baseline to Day 8; Day 29; Day 57 and Day 105

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2016

Primary Completion (Actual)

September 6, 2018

Study Completion (Actual)

December 3, 2018

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimated)

December 2, 2015

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

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.

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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