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Completed

NCT Number: NCT05885451

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

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Randwick, New South Wales, 2031, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMG 592

Drug

Administered as SC injection

Placebo

Other

Administered as SC injection

Primary outcomes

  1. Maximum Observed Serum Concentration (Cmax) of AMG 592

    Time frame: Up to Day 43

  2. Time of Maximum Observed Concentration (tmax) of AMG 592

    Time frame: Up to Day 43

  3. Area Under the Serum Concentration-time Curve to the Last Measurable Point (AUClast) of AMG 592

    Time frame: Up to Day 43

  4. Area Under the Concentration-time Curve (AUC) from Time Zero to Infinity (AUCinf)

    Time frame: Up to Day 43

Secondary outcomes

  1. Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)

    Time frame: Day 1 to Day 43

  2. Number of Participants who Experience Anti-AMG 592 Antibodies Formation

    Time frame: Up to Day 43

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase I, Double Blind, Placebo-controlled, Randomized, Parallel, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 Administered Subcutaneously in Healthy Japanese Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 2, 2023
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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