WCCT Global LLC
Cypress, California, 90630-4738, United States
NCT Number: NCT05056246
The primary objective of this study is to evaluate the pharmacokinetics (PK) of AMG 133 after single subcutaneous (SC) administration in healthy Japanese and Caucasian participants.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Cypress, California, 90630-4738, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Solution for SC injection
Other names: maridebart cafraglutide
Time frame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Time frame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Time frame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Time frame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Time frame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Time frame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Time frame: Day 1 to Day 120
A TEAE was defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with AMG 133 that started during or after dosing, or started prior to dosing and increased in severity after dosing.
Clinically significant changes from baseline in clinical laboratory tests, 12-lead electrocardiograms (ECGs) and vital signs were also reported as TEAEs.
Time frame: Days 1, 15, 29, 57 and 120
Blood samples were collected at specific times during the study for the measurement of anti-AMG 133 binding antibodies from participants who received AMG 133.
Amgen
Industry
A Phase I, Open-label, Randomized, Parallel-arm, Single-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Subjects
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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