A Phase 1b/2a Study of the Safety and Pharmacokinetics of Rhu-plasma Gelsolin in Hospitalized Subjects With CAP

Phase 1/2 Completed 33 enrolled BioAegis Therapeutics Inc.

RandomizedSequentialQuadruple-blindTreatment

Summary

A Phase 1b/2a, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Plasma gelsolin (rhu-pGSN) Added to Standard of Care in Subjects Hospitalized for Acute Community-acquired Pneumonia (CAP)

Timeline

Start: 2018-08-28
Primary completion: 2019-04-02
Completion: 2019-04-02

Publications

Tannous A, Levinson SL, Bolognese J, Opal SM, DiNubile MJ. Safety and Pharmacokinetics of Recombinant Human Plasma Gelsolin in Patients Hospitalized for Nonsevere Community-Acquired Pneumonia. Antimicrob Agents Chemother. 2020 Sep 21;64(10):e00579-20. doi: 10.1128/AAC.00579-20. Print 2020 Sep 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Recombinant human plasma gelsolin	Protein / enzyme biologic	6 mg/kg	Intravenous
Subject	Recombinant human plasma gelsolin	Protein / enzyme biologic	12 mg/kg	Intravenous
Subject	Recombinant human plasma gelsolin	Protein / enzyme biologic	24 mg/kg	Intravenous

A Phase 1b/2a Study of the Safety and Pharmacokinetics of Rhu-plasma Gelsolin in Hospitalized Subjects With CAP

Summary

Timeline

Publications

Drugs

Indications