更新于：2024-06-29
RO-7020531
更新于：2024-06-29
概要
基本信息
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)无进展 |
特殊审评- |
关联
6
项与 RO-7020531 相关的临床试验一项在慢性乙型肝炎受试者中评价多种联合治疗的有效性和安全性的II 期、随机、适应性、开放标签平台试验
一项在慢性乙型肝炎受试者中评价多种联合治疗的有效性和安全性的II 期、随机、适应性、开放标签平台试验
A Phase II, Randomised, Adaptive, Open-Label Platform Trial To Evaluate Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B
100 项与 RO-7020531 相关的临床结果
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100 项与 RO-7020531 相关的转化医学
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100 项与 RO-7020531 相关的专利（医药）
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2
项与 RO-7020531 相关的文献（医药）2023-04-01The Lancet. Infectious diseases
TLR7 agonist RO7020531 versus placebo in healthy volunteers and patients with chronic hepatitis B virus infection: a randomised, observer-blind, placebo-controlled, phase 1 trial
Article
作者: Balabanska, Rozalina ; Upmanyu, Ruchi ; Triyatni, Miriam ; Cottreel, Emmanuelle ; Zhu, Yonghong ; Chen, Ethan ; Canducci, Filippo ; Yuen, Man-Fung ; Duan, Dan ; Patil, Avinash ; Gane, Edward J ; Jiang, Qiudi
BACKGROUND:
Toll-like receptor 7 (TLR7) agonists augment immune activity and have potential for the treatment of chronic hepatitis B virus (HBV) infection. We aimed to assess the safety and tolerability of RO7020531 (also called RG7854), a prodrug of the TLR7 agonist RO7011785, in healthy volunteers and patients with chronic HBV infection.
METHODS:
This randomised, observer-blind, placebo-controlled, phase 1 study was done in two parts. Part 1 was done at one site in New Zealand and part 2 was done at 12 sites in Bulgaria, Hong Kong, Italy, New Zealand, the Netherlands, Taiwan, Thailand, and the UK. In part 1, healthy volunteers were randomly assigned (4:1) within one of eight dose cohorts (3 mg, 10 mg, 20 mg, 40 mg, 60 mg, 100 mg, 140 mg, or 170 mg) to receive a single RO7020531 dose or placebo or randomly assigned (4:1) within one of three dose cohorts (100 mg, 140 mg, or 170 mg) to receive either RO7020531 or placebo every other day for 13 days. In part 2, nucleoside or nucleotide analogue-suppressed patients with chronic HBV infection were randomly assigned (4:1) within cohorts 1-3 (150 mg, 150 mg, or 170 mg) to receive either RO7020531 or placebo and treatment-naive patients with chronic HBV infection were randomly assigned (3:1) in cohort 4 to receive either 150 mg of RO7020531 or placebo. Patients were treated every other day for 6 weeks. Study medication was administered orally to participants after they had fasted. Study participants and investigational staff were masked to treatment allocation. The primary outcome was the safety and tolerability of RO7020531, as measured by the incidence and severity of adverse events and the incidence of laboratory, vital sign, and electrocardiogram abnormalities, and was analysed in all participants who received at least one dose of the study medication. This trial is registered with ClinicalTrials.gov, NCT02956850, and the study is complete.
FINDINGS:
Between Dec 12, 2016, and March 21, 2021, 340 healthy volunteers were screened in part 1, of whom 80 were randomly assigned in the single ascending dose study (eight assigned RO7020531 in each cohort and 16 assigned placebo) and 30 were randomly assigned in the multiple ascending dose study (eight assigned RO7020531 in each cohort and six assigned placebo), and 110 patients were screened in part 2, of whom 30 were randomly assigned in cohorts 1-3 (16 assigned RO7020531 150 mg, eight assigned RO7020531 170 mg, and six assigned placebo) and 20 were randomly assigned in cohort 4 (15 assigned RO7020531 and five assigned placebo). All randomly assigned participants received at least one dose of a study drug and were included in the safety analysis. All tested doses of RO7020531 were safe and had acceptable tolerability in healthy volunteers and patients. The most frequent treatment-related adverse events among the total study population were headache (15 [9%] of 160 participants), influenza-like illness (seven [4%] of 160 participants), and pyrexia (ten [6%] of 160 participants). Most adverse events were mild and transient. There were no severe or serious adverse events in healthy volunteers. In the patient cohorts, there was one severe adverse event (influenza-like illness with 170 mg of RO7020531) and one serious adverse event (moderate influenza-like illness with a 3-day hospitalisation in a treatment-naive patient receiving RO7020531). There were no treatment-related deaths.
INTERPRETATION:
Due to acceptable safety and tolerability, RO7020531 should continue to be developed for the treatment of patients with chronic HBV infection.
FUNDING:
F Hoffmann-La Roche.
2020-09-01Clinical and translational science3区 · 医学
A Single and Multiple Ascending Dose Study of Toll‐Like Receptor 7 Agonist (RO7020531) in Chinese Healthy Volunteers
3区 · 医学
ArticleOA
作者: Zhu, Yonghong ; Jiang, Qiudi ; Zhao, Na ; Luk, Andrea ; Grippo, Joseph F. ; Glavini, Katerina ; Racek, Tomas ; Triyatni, Miriam
Toll‐like receptor 7 (TLR7) agonists modulate broad spectrum immune activity and are evaluated in the treatment of human diseases, including cancer and chronic viral infection. RO7020531, an oral prodrug of a TLR7 agonist, is in clinical development as part of a curative regimen against chronic hepatitis B. We report the safety, tolerability, pharmacokinetics (PKs), and pharmacodynamics (PDs) of RO7020531 in healthy Chinese volunteers following single and multiple ascending doses (SAD and MAD). PK and PD samples were evaluated from four SAD cohorts and 3 MAD cohorts with 10 subjects each (8 active and 2 placebo). Safety and tolerability were monitored throughout the study. A total of 155 adverse events (AEs) were reported in 49 subjects. Fifty‐one AEs in 18 subjects were assessed as treatment‐related. Most of the AEs were mild; nine subjects experienced moderate AEs; there were no severe AEs. In two 150 mg MAD cohorts given every other day (q.o.d.), 7 of 20 subjects experienced pyrexia and were discontinued due to transient asymptomatic lymphopenia, which resolved 24–48 hours postdose. The PK of the active metabolite, RO7011785, increased linearly with dose from 40 mg to 170 mg. There was no PK accumulation following q.o.d. dosing. The PK profile is consistent with observations in white subjects in the global first‐in‐human study. SADs and MADs of RO7020531 resulted in dose‐dependent increases in TLR7 response markers at 100 mg or above. Flu‐like symptoms were associated with higher interferon‐α levels. RO7020531 was safe and acceptably tolerated in healthy Chinese volunteers with a multiple 150 mg q.o.d. dose regimen.
1
项与 RO-7020531 相关的新闻（医药）2024-04-28
siRNA核酸药物基因疗法寡核苷酸临床研究
100 项与 RO-7020531 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 慢性乙型肝炎 | 临床2期 | 中国 | 2020-07-05 | |
| 慢性乙型肝炎 | 临床2期 | 加拿大 | 2020-07-05 | |
| 慢性乙型肝炎 | 临床2期 | 法国 | 2020-07-05 | |
| 慢性乙型肝炎 | 临床2期 | 新西兰 | 2020-07-05 | |
| 慢性乙型肝炎 | 临床2期 | 韩国 | 2020-07-05 | |
| 慢性乙型肝炎 | 临床2期 | 西班牙 | 2020-07-05 | |
| 慢性乙型肝炎 | 临床2期 | 泰国 | 2020-07-05 | |
| 慢性乙型肝炎 | 临床2期 | 英国 | 2020-07-05 | |
| 乙型肝炎 | 临床2期 | 英国 | 2020-04-01 |
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临床结果
临床结果
适应症
分期
评价
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临床1期 | - | 70 | Placebo (Single Ascending Dose (SAD): Placebo) | 獵願製鏇衊淵鏇構鏇繭(夢簾艱簾獵遞鑰積鏇窪) = 觸糧衊積鬱壓鹹製餘構 廠艱壓鹹窪廠積憲鏇襯 (繭淵願鏇鏇範糧鑰鏇築, 壓蓋衊遞網醖網蓋願艱 ~ 淵膚廠蓋遞壓廠獵窪鏇) 更多 | - | 2020-07-13 | |
(SAD: Cohort 1) | 獵願製鏇衊淵鏇構鏇繭(夢簾艱簾獵遞鑰積鏇窪) = 築襯衊範餘齋淵積願醖 廠艱壓鹹窪廠積憲鏇襯 (繭淵願鏇鏇範糧鑰鏇築, 範襯蓋鹽糧鏇襯遞積醖 ~ 範網鏇壓構積製鬱鬱襯) 更多 |
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