A Study to Assess the Safety and Tolerability of E8001 in Healthy Male Participants

Phase 1 Completed 36 enrolled Eisai Inc.

RandomizedParallel-groupSingle-blindOther

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of E8001 of single ascending dose intravenous infusions in healthy male participants.

Timeline

Start: 2020-10-28
Primary completion: 2023-08-18
Completion: 2023-08-18

Publications

Ishigooka H, Katsumata H, Saiga K, Tokita D, Motoi S, Matsui C, Suzuki Y, Tomimatsu A, Nakatani T, Kuboi Y, Yamakawa T, Ikeda T, Ishii R, Imai T, Takagi T, Tanabe K. Novel Complement C5 Small-interfering RNA Lipid Nanoparticle Prolongs Graft Survival in a Hypersensitized Rat Kidney Transplant Model. Transplantation. 2022 Dec 1;106(12):2338-2347. doi: 10.1097/TP.0000000000004207. Epub 2022 Nov 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	E8001	Small interfering RNA (siRNA)	—	Intravenous

Indications

No indication recorded.