A Study of RO7239958 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection

Phase 1 Terminated 55 enrolled Hoffmann-La Roche

RandomizedSequentialQuadruple-blindTreatment

Summary

This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses in healthy volunteers (HV) and participants diagnosed with chronic hepatitis B (CHB).

Timeline

Start: 2018-12-14
Primary completion: 2020-04-06
Completion: 2020-04-06

Outcome

Outcome not reported

Stopped: “The study was terminated due to program discontinuation.”

Publications

Geretti AM, Sostelly A, Buatois S, Lu S, Lemenuel A, Attley G, Bopst M, Alvarez-Sanchez R, Mueller H, Gane E. Safety, pharmacokinetics, and pharmacodynamics of the antisense oligonucleotide RO7239958 in healthy volunteers and adults with chronic hepatitis B infection. Antimicrob Agents Chemother. 2025 Dec 10;69(12):e0067925. doi: 10.1128/aac.00679-25. Epub 2025 Nov 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RO7239958	Antisense oligonucleotide	0.1 mg/kg	Subcutaneous
Subject	RO7239958	Antisense oligonucleotide	0.2 mg/kg	Subcutaneous
Subject	RO7239958	Antisense oligonucleotide	0.3 mg/kg	Subcutaneous
Subject	RO7239958	Antisense oligonucleotide	0.4 mg/kg	Subcutaneous
Subject	RO7239958	Antisense oligonucleotide	1 mg/kg	Subcutaneous
Subject	RO7239958	Antisense oligonucleotide	1.5 mg/kg	Subcutaneous