A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 in Healthy Japanese Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-29

Study Completion Date

2019-04-11

Brief Summary

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The primary objective of this study is to characterize the pharmacokinetics (PK) profile of a single dose of AMG 592 administered subcutaneously in healthy Japanese participants.

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Detailed Description

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Conditions

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Chronic Graft-versus-Host Disease (cGVHD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1: AMG 592 Dose 1

Participants will receive AMG 592 dose 1 subcutaneously

Group Type EXPERIMENTAL

AMG 592

Intervention Type DRUG

Administered as SC injection

Arm 2: AMG 592 Dose 2

Participants will receive AMG 592 dose 2 subcutaneously

Group Type EXPERIMENTAL

AMG 592

Intervention Type DRUG

Administered as SC injection

Arm 3: Placebo

Participants will receive placebo subcutaneously

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Administered as SC injection

Interventions

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AMG 592

Administered as SC injection

Intervention Type DRUG

Placebo

Administered as SC injection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participant must be first generation Japanese (4 grandparents, biologic parents, and subject born in Japan and of Japanese heritage)
* Male and female participants must be ≥ 18 and ≤ 55 years of age with a body mass index (BMI) of ≥ 18.5 and ≤ 25.0 kg/m\^2 at the time of screening

Exclusion Criteria

* Participant with history of prior malignancy within the last 5 years except malignancy (in situ) fully excised or treated with curative intent and with no known active disease present for ≥3 years before enrollment and felt to be at low risk for recurrence by the treating physician, non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
* Participants with a known history of autoimmune disease
* Participants who have donated or lost ≥ 500 mL of blood or plasma within 8 weeks of administration of the first dose of IP
* Participants with any active infection for which systemic anti-infectives were used within 4 weeks prior to Day 1
* Positive for Hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B)
* Participant has positive test results for Human Immunodeficiency Virus (HIV)
* Participant has a positive test for tuberculosis during screening defined as either a positive purified derivative (PPD) (\>= 5 mm of induration at 48 to 72 hours after test is placed) OR a positive QuantiFERON test

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes