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

Amgen

Status and phase: Completed; Phase 1

Conditions: Chronic Graft-versus-Host Disease (cGVHD)

Treatments: Drug: AMG 592; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05885451

20180132

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

18 participants in 3 patient groups, including a placebo group

Arm 1: AMG 592 Dose 1

Experimental group

Description:

Participants will receive AMG 592 dose 1 subcutaneously

Treatment:

Drug: AMG 592

Arm 2: AMG 592 Dose 2

Experimental group

Description:

Participants will receive AMG 592 dose 2 subcutaneously

Treatment:

Drug: AMG 592

Arm 3: Placebo

Placebo Comparator group

Description:

Participants will receive placebo subcutaneously

Treatment:

Other: Placebo