First in Human Study: LIS1, an Induction Treatment in Kidney Transplanted Patients

Phase 1/2 Completed 10 enrolled Xenothera SAS

Non-randomizedSequentialOpen-labelTreatment

Summary

This first in human study aims at evaluating LIS1, a stabilized solution of purified anti-T lymphocytes polyclonal glyco-humanized swine IgG with immunosuppressive activity, in regards of safety, T cell depletion, and pharmacokinetics / pharmacodynamics in 10 kidney transplant recipients.

Timeline

Start: 2019-11-26
Primary completion: 2022-03-28
Completion: 2022-03-28

Outcome

Met primary endpoint

release “The primary endpoint was product safety, LIS1 was well tolerated.” xenothera.com ↗

Publications

Viklicky O, Slatinska J, Janousek L, Rousse J, Royer PJ, Toutain PL, Cozzi E, Galli C, Evanno G, Duvaux O, Bach JM, Soulillou JP, Giral M, Vanhove B, Blancho G. First-in-human Study With LIS1, a Next-generation Porcine Low Immunogenicity Antilymphocyte Immunoglobulin in Kidney Transplantation. Transplantation. 2024 Jul 1;108(7):e139-e147. doi: 10.1097/TP.0000000000004967. Epub 2024 Feb 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LIS1	Protein / enzyme biologic	0.6 mg/kg	Intravenous
Subject	LIS1	Protein / enzyme biologic	1 mg/kg	Intravenous
Subject	LIS1	Protein / enzyme biologic	3 mg/kg	Intravenous
Subject	LIS1	Protein / enzyme biologic	6 mg/kg	Intravenous
Subject	LIS1	Protein / enzyme biologic	8 mg/kg	Intravenous
Subject	LIS1	Protein / enzyme biologic	10 mg/kg	Intravenous

Indications

No indication recorded.