A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 in Healthy Japanese Participants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1: AMG 592 Dose 1 Participants will receive AMG 592 dose 1 subcutaneously |
Drug: AMG 592
Administered as SC injection
|
| Experimental: Arm 2: AMG 592 Dose 2 Participants will receive AMG 592 dose 2 subcutaneously |
Drug: AMG 592
Administered as SC injection
|
| Placebo Comparator: Arm 3: Placebo Participants will receive placebo subcutaneously |
Other: Placebo
Administered as SC injection
|
Outcome Measures
Primary Outcome Measures
- 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]
- 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]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Randwick | New South Wales | Australia | 2031 |
Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20180132