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COMPLETED
NCT05909852
PHASE1

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

Sponsor: Amgen

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

372

Start Date

2021-07-23

Completion Date

2021-11-24

Last Updated

2026-06-25

Healthy Volunteers

Yes

Conditions

Interventions

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

Locations (3)

WCCT Global, Inc

Cypress, California, United States

Qps-Mra, Llc

South Miami, Florida, United States

Pharmaceutical Research Associates, Inc

Salt Lake City, Utah, United States