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

Sponsor
Amgen
Study ID
NCT05995691
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • ABP 501 — DRUG
    SC injection
  • Adalimumab — DRUG
    SC injection

Study Details

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.

Key Dates

Start date
Nov 24, 2014
Status verified
Aug 2023
Primary completion
Dec 4, 2015
Completion
Dec 4, 2015

Study Design

Enrollment
179 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: ABP 501
    Participants will receive a single dose of ABP 501
  • Active Comparator: Adalimumab
    Participants will receive a single dose of adalimumab

Primary Outcome Measure

AUCinf of ABP 501 [ Time Frame: Day 1 to Day 63 ]

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