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Completed

NCT Number: NCT02618967

Single Ascending Dose Study 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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Evansville, Indiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMG 570

Biological

7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers.

Other names: Active Comparator, Investigational Product, and Study drug

AMG 570 Matching Placebo

Biological

Placebo administered as single dose subcutaneous in healthy volunteers.

Other names: Placebo, Investigational Product, and Study drug

Primary outcomes

  1. 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

  2. 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).

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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

  8. Percentage Change From Baseline for CD19+ Total B Cells Percentages (%)

    Time frame: Baseline to Day 8; Day 29; Day 57 and Day 105

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 2, 2015
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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