Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous and Multiple Subcutaneous and Intravenous Doses of PF-06480605 in Healthy Subjects.

NCT01989143 ↗

Phase 1 Completed 92 enrolled Telavant, Inc. Pfizer · collab

RandomizedSequentialDouble-blindBasic science

Summary

This single and multiple ascending dose study is a first in human assessment of PF-06480605. The goal is to study the safety, tolerability, pharmacokinetics and pharmacodynamics.

Timeline

Start: 2013-12
Primary completion: 2015-03
Completion: 2015-03

Publications

Banfield C, Rudin D, Bhattacharya I, Goteti K, Li G, Hassan-Zahraee M, Brown LS, Hung KE, Pawlak S, Lepsy C. First-in-human, randomized dose-escalation study of the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of PF-06480605 in healthy subjects. Br J Clin Pharmacol. 2020 Apr;86(4):812-824. doi: 10.1111/bcp.14187. Epub 2020 Jan 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Afimkibart	Monoclonal antibody	1 mg	Intravenous
Subject	Afimkibart	Monoclonal antibody	3 mg	Intravenous
Subject	Afimkibart	Monoclonal antibody	10 mg	Intravenous
Subject	Afimkibart	Monoclonal antibody	30 mg	Intravenous
Subject	Afimkibart	Monoclonal antibody	100 mg	Intravenous
Subject	Afimkibart	Monoclonal antibody	300 mg	Intravenous
Subject	Afimkibart	Monoclonal antibody	500 mg	Intravenous
Subject	Afimkibart	Monoclonal antibody	600 mg	Intravenous
Subject	Afimkibart	Monoclonal antibody	800 mg	Intravenous

Indications

No indication recorded.