Single Ascending Dose Study of AMG 570 in Healthy Subjects

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-28

Study Completion Date

2018-12-03

Brief Summary

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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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Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AMG 570 - 70 mg

Participants will receive a single 70 mg dose of AMG 570 administered subcutaneously.

Group Type EXPERIMENTAL

AMG 570

Intervention Type BIOLOGICAL

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

AMG 570 - 140 mg

Participants will receive a single 140 mg dose of AMG 570 administered subcutaneously.

Group Type EXPERIMENTAL

AMG 570

Intervention Type BIOLOGICAL

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

AMG 570 - 210 mg

Participants will receive a single 210 mg dose of AMG 570 administered subcutaneously.

Group Type EXPERIMENTAL

AMG 570

Intervention Type BIOLOGICAL

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

AMG 570 - 420 mg

Participants will receive a single 420 mg dose of AMG 570 administered subcutaneously.

Group Type EXPERIMENTAL

AMG 570

Intervention Type BIOLOGICAL

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

AMG 570 - 7 mg

Participants will receive a single dose 7 mg dose of AMG 570 administered subcutaneously.

Group Type EXPERIMENTAL

AMG 570

Intervention Type BIOLOGICAL

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

AMG 570 - 21 mg

Participants will receive a single 21 mg dose of AMG 570 administered subcutaneously.

Group Type EXPERIMENTAL

AMG 570

Intervention Type BIOLOGICAL

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

AMG 570 - 700 mg

Participants will receive a single 700 mg dose of AMG 570 administered subcutaneously.

Group Type EXPERIMENTAL

AMG 570

Intervention Type BIOLOGICAL

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

Placebo

Participants will receive a single dose of the matching AMG 570 placebo administered subcutaneously.

Group Type PLACEBO_COMPARATOR

AMG 570 Matching Placebo

Intervention Type BIOLOGICAL

Placebo administered as single dose subcutaneous in healthy volunteers.

Interventions

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AMG 570

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

Intervention Type BIOLOGICAL

AMG 570 Matching Placebo

Placebo administered as single dose subcutaneous in healthy volunteers.

Intervention Type BIOLOGICAL

Other Intervention Names

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Active Comparator, Investigational Product, and Study drug Placebo, Investigational Product, and Study drug

Eligibility Criteria

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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

Exclusion Criteria

* Current or chronic history of liver disease
* History of active infections
* History of significant respiratory disorder
* Evidence of renal disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes