更新于：2024-10-03
JNJ-440
更新于：2024-10-03
概要
基本信息
药物类型 小分子化药 |
别名 ALS-003440、JNJ 440、JNJ-0440 + [2] |
作用机制 HBV capsid抑制剂(HBV衣壳蛋白抑制剂) |
在研适应症- |
非在研适应症 |
在研机构- |
最高研发阶段终止临床1期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
关联
3
项与 JNJ-440 相关的临床试验A Study in Healthy Female Participants to Investigate the Effect of JNJ-64530440 on the Single-dose of Ethinylestradiol and Drospirenone (Oral Contraceptive), and Midazolam, and the Effect of a High-fat Meal on the Single-dose of JNJ-64530440
A Double-blind, Placebo-controlled, Randomized, Single Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-64530440 in Healthy Japanese Male Subjects
A Multipart Phase 1, Double-Blind, Randomized, Placebo-Controlled, First-in-Human, Study of Orally Administered JNJ-440 to Evaluate the Safety, Tolerability, and Pharmacokinetics After Single Ascending Doses Including Food Effect Evaluation (Part 1); After Multi-Day Dosing (Part 2) in Healthy Subjects; and After Multiple (Ascending) Doses in Subjects With Chronic Hepatitis B (Part 3)
100 项与 JNJ-440 相关的临床结果
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100 项与 JNJ-440 相关的转化医学
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100 项与 JNJ-440 相关的专利（医药）
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2
项与 JNJ-440 相关的文献（医药）2022-03-31The Journal of antimicrobial chemotherapy2区 · 医学
Safety, antiviral activity and pharmacokinetics of JNJ-64530440, a novel capsid assembly modulator, as 4 week monotherapy in treatment-naive patients with chronic hepatitis B virus infection
2区 · 医学
Article
作者: Dragone, Leonard ; Yogaratnam, Jeysen Z. ; Lenz, Oliver ; Kakuda, Thomas N. ; Patel, Megha ; Schwabe, Christian ; Berliba, Elina ; Gane, Ed J. ; Ghicavii, Nelea ; Westland, Chris ; Verbinnen, Thierry ; Jucov, Alina ; Van Remoortere, Pieter ; Tangkijvanich, Pisit ; Talloen, Willem
Abstract:
Objectives:
We investigated JNJ-64530440 (a hepatitis B virus capsid assembly modulator) safety, antiviral activity and pharmacokinetics in patients with chronic hepatitis B (CHB) (Phase 1b, NCT03439488).
Methods:
Twenty treatment-naive, HBeAg-positive or -negative CHB patients were randomized 4:1 to JNJ-64530440 750 mg once or twice daily, or placebo for 28 days.
Results:
All patients (mean age 43.8 years; 85% male; 70% White; 20% HBeAg positive) completed dosing/28 day follow-up. Mild-to-moderate treatment-emergent adverse events occurred in 3/4 (placebo), 6/8 (once-daily) and 4/8 (twice-daily) patients; mostly fatigue, increased alanine aminotransferase, decreased neutrophil count, and headache. Hepatitis B virus (HBV) DNA was substantially reduced; mean (range) changes from baseline at day 29 were: −3.2 (−2.4 to −3.9) (once-daily) and −3.3 (−2.6 to −4.1) (twice-daily) log10 IU/mL; placebo 0.1 (0.7 to −0.6) log10 IU/mL. HBV DNA levels were below the lower limit of quantification (LLOQ) in 5/8 (once-daily) and 3/8 (twice-daily) patients. For patients with detectable baseline HBV RNA, mean (SE) changes versus baseline in HBV RNA at day 29 were: −2.65 (0.81) (once-daily) and −2.94 (0.33) (twice-daily) log10 copies/mL. HBV RNA levels were ‘target not detected’ in 4/6 (once-daily) and 3/7 (twice-daily) patients. JNJ-64530440 pharmacokinetics in CHB patients were comparable with those in healthy volunteers.
Conclusions:
JNJ-64530440 750 mg once-daily or twice-daily for 28 days was well tolerated and achieved potent antiviral activity in CHB patients.
2021-01-01Antiviral therapy4区 · 医学
Pharmacokinetics, safety and tolerability of single- and multiple-ascending doses of JNJ-64530440, a novel hepatitis B virus capsid assembly modulator, in healthy volunteers
4区 · 医学
Article
作者: Gane, Edward J ; Chanda, Sushmita ; Westland, Christopher ; Yogaratnam, Jeysen Z ; Fry, John ; van Remoortere, Pieter ; Kakuda, Thomas N ; Snoeys, Jan ; Schwabe, Christian ; Lenz, Oliver ; Patel, Megha ; Vuong, Jennifer ; Talloen, Willem
Background:
Pharmacokinetics and safety of JNJ-64530440, a hepatitis B virus capsid assembly modulator producing normal empty capsids (CAM-N), in healthy volunteers were evaluated.
Methods:
This Phase I study (NCT03439488) was a double-blind, randomised, placebo-controlled study. Adults ( n = 10/cohort, five Asian/five non-Asian), randomised 4:1, received single-ascending doses of oral JNJ-64530440 (first- and second-generation formulations) or placebo under fasted (50, 150, 300 and 900 mg) or fed (300, 750, 1,000, 2000 and 4000 mg) conditions. Multiple-ascending doses of 750 or 2000 mg once daily and 750 mg twice daily JNJ-64530440 (second-generation formulation) for 7 days were evaluated. Pharmacokinetic parameters were estimated from plasma concentrations. Safety was assessed throughout.
Results:
Less than dose-proportional increases in maximum plasma concentrations (Cmax) and area under the plasma concentration–time curves (AUCs) were observed across the doses. Mean plasma half-lives ranged from 9.3 to 14.5 h. Cmax and AUC were ∼two fold higher under fed versus fasting conditions and slightly higher in Asians versus Caucasians. JNJ-64530440 doses ≥750 mg achieved plasma levels higher than protein-binding adjusted concentrations demonstrating in vitro antiviral activity. No serious adverse events (AEs), treatment discontinuations or dose-limiting toxicities were seen. AE frequency/severity did not increase with dose.
Conclusions:
Single (up to 4000 mg) and multiple doses (up to 2000 mg for 7 days) of JNJ-64530440 were well tolerated in healthy volunteers. Multiple doses ≥750 mg/day achieved plasma concentrations expected to have antiviral activity that may lower hepatitis B surface antigen. No clinically relevant differences in tolerability or pharmacokinetic parameters were seen between Asians versus Caucasians.
1
项与 JNJ-440 相关的新闻（医药）2023-08-12
·药时代
临床1期疫苗临床申请临床2期
100 项与 JNJ-440 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1期 | 摩尔多瓦 | 2018-03-26 | |
| 慢性乙型肝炎 | 临床1期 | 新西兰 | 2018-03-26 | |
| 慢性乙型肝炎 | 临床1期 | 韩国 | 2018-03-26 | |
| 慢性乙型肝炎 | 临床1期 | 泰国 | 2018-03-26 | |
| 慢性乙型肝炎 | 临床1期 | 乌克兰 | 2018-03-26 |
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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 | - | 100 | 齋襯襯範繭淵廠觸鏇製(餘觸簾窪繭鹹壓醖獵鹹) = There were no withdrawals due to adverse events (AEs), serious AEs, or dose limiting toxicities. AEs and lab abnormalities were mostly Grade 1 or 2. Related AEs (n ≥ 2) included headache (n = 8), fatigue (n = 2) and contusion (n = 2). No clinically relevant changes in electrocardiograms were observed. 襯鑰獵衊憲鑰構簾糧艱 (壓選窪夢觸鹽襯繭壓選 ) | 积极 | 2019-04-12 |
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