Single Ascending Dose Study of AMG 570 in Healthy Subjects

Amgen

Status and phase: Completed; Phase 1

Conditions: Systemic Lupus Erythematosus

Treatments: Biological: AMG 570; Biological: AMG 570 Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02618967

20140322

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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56 participants in 8 patient groups, including a placebo group

AMG 570 - 7 mg

Experimental group

Description:

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

Treatment:

Biological: AMG 570

AMG 570 - 21 mg

Experimental group

Description:

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

Treatment:

Biological: AMG 570

AMG 570 - 70 mg

Experimental group

Description:

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

Treatment:

Biological: AMG 570

AMG 570 - 140 mg

Experimental group

Description:

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

Treatment:

Biological: AMG 570

AMG 570 - 210 mg

Experimental group

Description:

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

Treatment:

Biological: AMG 570

AMG 570 - 420 mg

Experimental group

Description:

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

Treatment:

Biological: AMG 570

AMG 570 - 700 mg

Experimental group

Description:

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

Treatment:

Biological: AMG 570

Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: AMG 570 Matching Placebo