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Study to Determine the Pharmacokinetic (PK) Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese Participants

NCT05995691 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2023-08-16

No results posted yet for this study

Summary

The primary objective of this study is to determine the bioequivalence of ABP 501 (subcutaneous \[SC\] injection) compared to adalimumab (SC injection) as assessed principally by the area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf), and maximum observed serum concentration (Cmax) in Japanese participants.

Conditions

  • Healthy Volunteers

Interventions

DRUG

ABP 501

SC injection

DRUG

Adalimumab

SC injection

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-24
Primary Completion
2015-12-04
Completion
2015-12-04
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05995691 on ClinicalTrials.gov