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

Phase 1

Completed

• Conditions: Chronic Graft-versus-Host Disease (cGVHD)
• Interventions: Drug: AMG 592; Other: Placebo

• Registration Number: NCT05885451
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-29
• Primary Completion: 2019-04-11
• Study Completion: 2019-04-11
• Status Verified: 2023-04
• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-05-23
• Last Update Submitted: 2023-05-23
• Study First Posted: 2023-06-02
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: AMG 592 Dose 2	AMG 592	Participants will receive AMG 592 dose 2 subcutaneously
Arm 3: Placebo	Placebo	Participants will receive placebo subcutaneously
Arm 1: AMG 592 Dose 1	AMG 592	Participants will receive AMG 592 dose 1 subcutaneously

Primary Outcome Measures

Name	Time	Method
Area Under the Serum Concentration-time Curve to the Last Measurable Point (AUClast) of AMG 592	Up to Day 43
Area Under the Concentration-time Curve (AUC) from Time Zero to Infinity (AUCinf)	Up to Day 43
Maximum Observed Serum Concentration (Cmax) of AMG 592	Up to Day 43
Time of Maximum Observed Concentration (tmax) of AMG 592	Up to Day 43

Secondary Outcome Measures

Name	Time	Method
Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)	Day 1 to Day 43
Number of Participants who Experience Anti-AMG 592 Antibodies Formation	Up to Day 43

Trial Locations

Locations (1)

Research Site; 🇦🇺 Randwick, New South Wales, Australia