A Study of JNJ-73763989 in Healthy Japanese Adult Participants

Phase 1 Completed 25 enrolled Janssen Sciences Ireland UC

RandomizedParallel-groupDouble-blindOther

Summary

The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of JNJ-73763989 in healthy Japanese adult participants following single-dose subcutaneous administration of 3 different doses of JNJ-73763989, Dose Level 1 (Panel A), Dose Level 2 (Panel B) or Dose Level 3 (Panel C).

Timeline

Start: 2019-07-04
Primary completion: 2019-08-23
Completion: 2019-08-23

Publications

Gane E, Yuen MF, Kakuda TN, Ogawa T, Takahashi Y, Goeyvaerts N, Lonjon-Domanec I, Vaughan T, Schluep T, Hamilton J, Njumbe Ediage E, Hillewaert V, Snoeys J, Lenz O, Talloen W, Biermer M. JNJ-73763989 pharmacokinetics and safety: Liver-targeted siRNAs against hepatitis B virus, in Japanese and non-Japanese healthy adults, and combined with JNJ-56136379 and a nucleos(t)ide analogue in patients with chronic hepatitis B. Antivir Ther. 2022 Jun;27(3):13596535221093856. doi: 10.1177/13596535221093856.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	JNJ-73763989	Small interfering RNA (siRNA)	25 mg	Subcutaneous
Subject	JNJ-73763989	Small interfering RNA (siRNA)	100 mg	Subcutaneous
Subject	JNJ-73763989	Small interfering RNA (siRNA)	200 mg	Subcutaneous

Indications

No indication recorded.