Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of BOS161721 in Healthy Subjects

Phase 1 Completed 61 enrolled Boston Pharmaceuticals

RandomizedParallel-groupTriple-blindBasic science

Summary

Study BOS161721-01 is a randomized, single center, double-blind, placebo-controlled trial conducted to study the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending intravenous (IV) and subcutaneous (SC) doses of BOS161721 or placebo in healthy adult male and female participants.

Timeline

Start: 2017-01
Primary completion: 2018-04-27
Completion: 2018-04-27

Publications

Hussaini A, Mukherjee R, Berdieva DM, Glogowski C, Mountfield R, Ho PTC. A Double-Blind, Phase I, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of BOS161721 in Healthy Subjects. Clin Transl Sci. 2020 Mar;13(2):337-344. doi: 10.1111/cts.12715. Epub 2019 Nov 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AVIZAKIMAB	Monoclonal antibody	1 mg	Intravenous
Subject	AVIZAKIMAB	Monoclonal antibody	3 mg	Intravenous
Subject	AVIZAKIMAB	Monoclonal antibody	10 mg	Intravenous
Subject	AVIZAKIMAB	Monoclonal antibody	22 mg	Intravenous
Subject	AVIZAKIMAB	Monoclonal antibody	30 mg	Intravenous
Subject	AVIZAKIMAB	Monoclonal antibody	60 mg	Intravenous
Subject	AVIZAKIMAB	Monoclonal antibody	120 mg	Intravenous
Subject	AVIZAKIMAB	Monoclonal antibody	240 mg	Intravenous

Indications

No indication recorded.