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

• Status: Completed
• Trial end date: 2019-04-11
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Amgen

Criteria

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