NCT05909852

A Study Comparing the Pharmacokinetics (PK) of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 ml (ABP 501-LCF) in Healthy Adult Participants

A Randomized, Single-blind, Single-dose, 2-arm, Parallel-group Study to Determine the Pharmacokinetic Comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 mL (ABP 501-LCF) in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 372 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To determine the pharmacokinetic (PK) comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF) compared to ABP 501 40 mg/0.8 mL (ABP 501-LCF) following single-dose subcutaneous (SC) injection, as assessed principally by area under the serum concentration-time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and maximum observed serum concentration (Cmax) in healthy adult participants.

Conditions

• Adalimumab

Interventions

Type	Name	Description
DRUG	ABP 501-HCF	Participants will receive a single-dose SC injection of ABP 501-HCF.
DRUG	ABP 501-LCF	Participants will receive a single-dose SC injection of ABP 501-LCF

Timeline

• Start date: 2021-07-23
• Primary completion: 2021-11-24
• Completion: 2021-11-24
• First posted: 2023-06-18
• Last updated: 2023-06-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study