Single Ascending Dose Study of AMG 570 in Healthy Subjects

Phase 1 Completed 56 enrolled Amgen

RandomizedSingle-groupQuadruple-blindTreatment

Summary

The purpose of this study is to obtain initial information on the safety and tolerability (effects good or bad), pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of a single dose of AMG 570.

Timeline

Start: 2016-03-28
Primary completion: 2018-09-06
Completion: 2018-12-03

Publications

Background Abuqayyas L, Chen PW, Dos Santos MT, Parnes JR, Doshi S, Dutta S, Houk BE. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Properties of Rozibafusp Alfa, a Bispecific Inhibitor of BAFF and ICOSL: Analyses of Phase I Clinical Trials. Clin Pharmacol Ther. 2023 Aug;114(2):371-380. doi: 10.1002/cpt.2929. Epub 2023 May 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rozibafusp Alfa	Protein / enzyme biologic	7 mg	Subcutaneous
Subject	Rozibafusp Alfa	Protein / enzyme biologic	21 mg	Subcutaneous
Subject	Rozibafusp Alfa	Protein / enzyme biologic	70 mg	Subcutaneous
Subject	Rozibafusp Alfa	Protein / enzyme biologic	140 mg	Subcutaneous
Subject	Rozibafusp Alfa	Protein / enzyme biologic	210 mg	Subcutaneous
Subject	Rozibafusp Alfa	Protein / enzyme biologic	420 mg	Subcutaneous
Subject	Rozibafusp Alfa	Protein / enzyme biologic	700 mg	Subcutaneous

Single Ascending Dose Study of AMG 570 in Healthy Subjects

Summary

Timeline

Publications

Drugs

Indications