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32 results on '"Triyatni, Miriam"'

1. Infection in NMOSD: Analyzing the Patterns of Infection in the SAkura Studies, Satralizumab Post-marketing Data, and NMOSD US PharMetrics Claims Data (P10-14.003)

Author

Greenberg, Benjamin M., primary, Fujihara, Kazuo, additional, Weinshenker, Brian, additional, Patti, Francesco, additional, Kleiter, Ingo, additional, Bennett, Jeffrey L., additional, Palace, Jacqueline, additional, Triyatni, Miriam, additional, Blondeau, Kathleen, additional, Burdeska, Alexander, additional, Ngwa, Innocent, additional, Klingelschmitt, Gaëlle, additional, and Yamamura, Takashi, additional

Published
2024
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2. Efficacy, safety, and pharmacokinetics of capsid assembly modulator linvencorvir plus standard of care in chronic hepatitis B patients

Author

Hou, Jinlin, primary, Gane, Edward, additional, Balabanska, Rozalina, additional, Zhang, Wenhong, additional, Zhang, Jiming, additional, Lim, Tien Huey, additional, Xie, Qing, additional, Yeh, Chau-Ting, additional, Yang, Sheng-Shun, additional, Liang, Xieer, additional, Komolmit, Piyawat, additional, Leerapun, Apinya, additional, Xue, Zenghui, additional, Chen, Ethan, additional, Zhang, Yuchen, additional, Xie, Qiaoqiao, additional, Chang, Ting-Tsung, additional, Hu, Tsung-Hui, additional, Lim, Seng Gee, additional, Chuang, Wan-Long, additional, Leggett, Barbara, additional, Bo, Qingyan, additional, Zhou, Xue, additional, Triyatni, Miriam, additional, Zhang, Wen, additional, and Yuen, Man-Fung, additional

Published
2024
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5. 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

Author

Yuen, Man-Fung, primary, Balabanska, Rozalina, additional, Cottreel, Emmanuelle, additional, Chen, Ethan, additional, Duan, Dan, additional, Jiang, Qiudi, additional, Patil, Avinash, additional, Triyatni, Miriam, additional, Upmanyu, Ruchi, additional, Zhu, Yonghong, additional, Canducci, Filippo, additional, and Gane, Edward J, additional

Published
2022
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6. Viral nucleic acids suppression activity of RO7049389 plus NUC with/without Peg-IFN in virologically-suppressed and naive chronic hepatitis B patients: 48-week treatment and post-treatment follow-up

Author

Yuen, Man-Fung, primary, Balabanska, Rozalina, additional, Hou, Jinlin, additional, Gane, Edward J, additional, Lim, Tien Huey, additional, Zhang, WenHong, additional, Xie, Qing, additional, Komolmit, Piyawat, additional, Leerapun, Apinya, additional, Yang, Sheng-Shun, additional, Yeh, Chau-Ting, additional, Zhang, Wen, additional, Zhou, Xue, additional, Xue, Zenghui, additional, Triyatni, Miriam, additional, Chen, Ethan, additional, Li, Rui, additional, and Bo, Qingyan, additional

Published
2022
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7. Hepatitis B virus antigen reduction effect of RO7049389 plus NUC with/without Peg-IFN in chronic hepatitis B patients

Author

Hou, Jinlin, primary, Gane, Edward J, additional, Zhang, Wenhong, additional, Zhang, Jiming, additional, Yuen, Man-Fung, additional, Lim, Tien Huey, additional, Balabanska, Rozalina, additional, Xie, Qing, additional, Komolmit, Piyawat, additional, Liang, Xieer, additional, Zhang, Wen, additional, Zhou, Xue, additional, Xue, Zenghui, additional, Triyatni, Miriam, additional, Chen, Ethan, additional, Zhang, Yuchen, additional, and Bo, Qingyan, additional

Published
2022
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9. Clinical Study of Single‐Stranded Oligonucleotide RO7062931 in Healthy Volunteers and Patients With Chronic Hepatitis B

Author

Gane, Edward, primary, Yuen, Man‐Fung, additional, Kim, Dong Joon, additional, Chan, Henry Lik‐Yuen, additional, Surujbally, Bernadette, additional, Pavlovic, Vedran, additional, Das, Sudip, additional, Triyatni, Miriam, additional, Kazma, Remi, additional, Grippo, Joseph F., additional, Buatois, Simon, additional, Lemenuel‐Diot, Annabelle, additional, Krippendorff, Ben‐Fillippo, additional, Mueller, Henrik, additional, Zhang, Yuchen, additional, Kim, Hyung Joon, additional, Leerapun, Apinya, additional, Lim, Tien Huey, additional, Lim, Young‐Suk, additional, Tanwandee, Tawesak, additional, Kim, Won, additional, Cheng, Wendy, additional, Hu, Tsung‐Hui, additional, and Wat, Cynthia, additional

Published
2021
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11. Evaluation of the safety, tolerability, and pharmacokinetics of RO7049389 in healthy Chinese volunteers.

Author

Wu, Xiaojie, Feng, Sheng, Zhang, Jing, Zhang, Wenhong, Zhang, Yuchen, Zhu, Mingfen, Triyatni, Miriam, Zhao, Na, Bo, Qingyan, and Jin, Yuyan

Subjects
HEPATITIS B virus, PHARMACOKINETICS, VOLUNTEERS, ASIANS, VOLUNTEER service
Abstract

The objectives of this phase I study are to assess the safety, tolerability, and pharmacokinetics (PKs) of RO7049389 in healthy Chinese volunteers (HVs) and evaluate potential ethnic differences in the safety and PKs using data from this study and the first‐in‐human study (in which most of the HVs were non‐Asian). HVs randomly received a single dose of 200–600 mg of RO7049389 or a placebo in a single ascending dose (n = 28) or multiple doses of 200–400 mg of RO7049389 or a placebo in multiple ascending doses (n = 24). Safety and tolerability were monitored throughout the study. Serial blood samples were collected for PK analysis. RO7049389 was safe and well‐tolerated in the HVs. The time to maximum concentration ranged from 1.5 to 3.0 h, and terminal half‐life ranged from 3.66 to 14.6 h. A single dose of 200–600 mg and multiple doses of 200–400 mg exhibited nonlinear PKs. In general, the safety profiles were comparable between non‐Asian and Asian HVs, but the plasma exposure of RO7049389 in Chinese HVs was higher than that in non‐Asian HVs. The data generated from this study will provide guidance for future clinical studies on RO7049389 in Chinese/Asian patients with hepatitis B virus. [ABSTRACT FROM AUTHOR]

Published
2022
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13. RO7062931 antisense oligonucleotide phase 1 study demonstrates target engagement in patients with chronic hepatitis B on established nucleos(t)ide therapy

Author

Yuen, Man-Fung, primary, Gane, Edward, additional, Kim, Dong Joon, additional, Chan, Henry, additional, Surujbally, Bernadette, additional, Pavlovic, Vedran, additional, Triyatni, Miriam, additional, Grippo, Joseph, additional, Kim, Hyung Joon, additional, Leerapun, Apinya, additional, Lim, Tien Huey, additional, Lim, Young-Suk, additional, Tanwandee, Tawesak, additional, Kim, Won, additional, Cheng, Wendy, additional, Hu, Tsung-Hui, additional, and Wat, Cynthia, additional

Published
2020
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15. The Genome Sequence of the Eastern Woodchuck (Marmota monax) – A Preclinical Animal Model for Chronic Hepatitis B

Author

Alioto, Tyler S, primary, Cruz, Fernando, additional, Gómez-Garrido, Jèssica, additional, Triyatni, Miriam, additional, Gut, Marta, additional, Frias, Leonor, additional, Esteve-Codina, Anna, additional, Menne, Stephan, additional, Kiialainen, Anna, additional, Kumpesa, Nadine, additional, Birzele, Fabian, additional, Schmucki, Roland, additional, Gut, Ivo G, additional, and Spleiss, Olivia, additional

Published
2019
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18. Simultaneous Assessment of Clearance, Metabolism, Induction, and Drug-Drug Interaction Potential Using a Long-Term In Vitro Liver Model for a Novel Hepatitis B Virus Inhibitor

Author

Kratochwil, Nicole A., primary, Triyatni, Miriam, additional, Mueller, Martina B., additional, Klammers, Florian, additional, Leonard, Brian, additional, Turley, Dan, additional, Schmaler, Josephine, additional, Ekiciler, Aynur, additional, Molitor, Birgit, additional, Walter, Isabelle, additional, Gonsard, Pierre-Alexis, additional, Tournillac, Charles A., additional, Durrwell, Alexandre, additional, Marschmann, Michaela, additional, Jones, Russell, additional, Ullah, Mohammed, additional, Boess, Franziska, additional, Ottaviani, Giorgio, additional, Jin, Yuyan, additional, Parrott, Neil J., additional, and Fowler, Stephen, additional

Published
2018
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19. Metabolic Profiling of Human Long-Term Liver Models and Hepatic Clearance Predictions from In Vitro Data Using Nonlinear Mixed-Effects Modeling

Author

Kratochwil, Nicole A., primary, Meille, Christophe, additional, Fowler, Stephen, additional, Klammers, Florian, additional, Ekiciler, Aynur, additional, Molitor, Birgit, additional, Simon, Sandrine, additional, Walter, Isabelle, additional, McGinnis, Claudia, additional, Walther, Johanna, additional, Leonard, Brian, additional, Triyatni, Miriam, additional, Javanbakht, Hassan, additional, Funk, Christoph, additional, Schuler, Franz, additional, Lavé, Thierry, additional, and Parrott, Neil J., additional

Published
2017
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20. Correction: Intrahepatic Transcriptional Signature Associated with Response to Interferon-α Treatment in the Woodchuck Model of Chronic Hepatitis B

Author

Fletcher, Simon P., primary, Chin, Daniel J., additional, Gruenbaum, Lore, additional, Bitter, Hans, additional, Rasmussen, Erik, additional, Ravindran, Palanikumar, additional, Swinney, David C., additional, Birzele, Fabian, additional, Schmucki, Roland, additional, Lorenz, Stefan H., additional, Kopetzki, Erhard, additional, Carter, Jade, additional, Triyatni, Miriam, additional, Thampi, Linta M., additional, Yang, Junming, additional, AlDeghaither, Dalal, additional, Murreddu, Marta G., additional, Cote, Paul, additional, and Menne, Stephan, additional

Published
2016
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22. Intrahepatic Transcriptional Signature Associated with Response to Interferon-α Treatment in the Woodchuck Model of Chronic Hepatitis B

Author

Fletcher, Simon P., primary, Chin, Daniel J., additional, Gruenbaum, Lore, additional, Bitter, Hans, additional, Rasmussen, Erik, additional, Ravindran, Palanikumar, additional, Swinney, David C., additional, Birzele, Fabian, additional, Schmucki, Roland, additional, Lorenz, Stefan H., additional, Kopetzki, Erhard, additional, Carter, Jade, additional, Triyatni, Miriam, additional, Thampi, Linta M., additional, Yang, Junming, additional, AlDeghaither, Dalal, additional, Murredu, Marta G., additional, Cote, Paul, additional, and Menne, Stephan, additional

Published
2015
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29. 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.

Author

Yuen, Man-Fung, Balabanska, Rozalina, Cottreel, Emmanuelle, Chen, Ethan, Duan, Dan, Jiang, Qiudi, Patil, Avinash, Triyatni, Miriam, Upmanyu, Ruchi, Zhu, Yonghong, Canducci, Filippo, and Gane, Edward J

Subjects
*HEPATITIS B, *CHRONIC hepatitis B, *TOLL-like receptors, *VOLUNTEERS, *ADVERSE health care events
Abstract

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. 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. 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. Due to acceptable safety and tolerability, RO7020531 should continue to be developed for the treatment of patients with chronic HBV infection. F Hoffmann-La Roche. [ABSTRACT FROM AUTHOR]

Published
2023
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30. AS069 - RO7062931 antisense oligonucleotide phase 1 study demonstrates target engagement in patients with chronic hepatitis B on established nucleos(t)ide therapy.

Author

Yuen, Man-Fung, Gane, Edward, Kim, Dong Joon, Chan, Henry, Surujbally, Bernadette, Pavlovic, Vedran, Triyatni, Miriam, Grippo, Joseph, Kim, Hyung Joon, Leerapun, Apinya, Lim, Tien Huey, Lim, Young-Suk, Tanwandee, Tawesak, Kim, Won, Cheng, Wendy, Hu, Tsung-Hui, and Wat, Cynthia

Subjects
*CHRONIC hepatitis B, *HEPATITIS B
Published
2020
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31. Using exploratory pharmacokinetic and pharmacodynamic analyses to predict the probability of flu-like symptoms in healthy volunteers and patients with chronic hepatitis B treated with the toll-like receptor 7 agonist ruzotolimod.

Author

Jiang Q, Zhang Y, Duan D, Retout S, Upmanyu R, Glavini K, Triyatni M, Zhu Y, Grippo JF, and Jin Y

Subjects
Humans, Male, Adult, Female, Middle Aged, Young Adult, Antiviral Agents pharmacokinetics, Antiviral Agents administration & dosage, Antiviral Agents adverse effects, Influenza, Human drug therapy, Influenza, Human immunology, Dose-Response Relationship, Drug, Adolescent, Administration, Oral, Organic Chemicals, Toll-Like Receptor 7 agonists, Healthy Volunteers, Hepatitis B, Chronic drug therapy, Hepatitis B, Chronic immunology, Hepatitis B, Chronic virology, Hepatitis B, Chronic blood
Abstract

Ruzotolimod (Toll-like receptor 7 (TLR7) agonist, RG7854) is an oral, small molecule immuno-modulator activating the TLR 7 and is being evaluated in patients with CHB. As with other TLR7 agonists, the study drug-related adverse events of flu-like symptoms have been reported in some participants during phase I studies with ruzotolimod. An exploratory analysis of the relationship between pharmacokinetic (PK)/pharmacodynamic (PD) and flu-like symptoms was performed in participants from two phase I studies including both healthy volunteers and NUC-suppressed CHB patients who received either single or multiple ascending doses of orally administered ruzotolimod. Linear and logistic regression were used to explore potential relationships between dose, flu-like symptoms, PK, and PD. Generalized linear regression was performed to predict the probability of flu-like symptoms of all intensities at different RO7011785 (the active metabolite of the double prodrug ruzotolimod) PK exposure. This analysis showed that single or multiple doses of ruzotolimod at ⩾100 mg, the immune PD (IFN-α, neopterin, IP-10, and the transcriptional expression of ISG15, OAS-1, MX1, and TLR7) responses increase with the RO7011785 PK exposure, which increases linearly with the doses from 3 mg to 170 mg of ruzotolimod. The analysis also showed that the probability of flu-like symptoms occurrence increases with PD responses (IFN-α and IP-10). Dose reduction of ruzotolimod can be an effective way to reduce the magnitude of PD response, thus reducing the probability of study drug-related flu-like symptoms occurrence at all intensity in the participants who are highly sensitive to PD activation and intolerant to flu-like symptoms., (© 2024 The Author(s). Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Published
2024
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32. Evaluation of the safety, tolerability, and pharmacokinetics of RO7049389 in healthy Chinese volunteers.

Author

Wu X, Feng S, Zhang J, Zhang W, Zhang Y, Zhu M, Triyatni M, Zhao N, Bo Q, and Jin Y

Subjects
Adolescent, Adult, China, Double-Blind Method, Female, Hepatitis B, Chronic drug therapy, Humans, Male, Middle Aged, Young Adult, Antiviral Agents pharmacokinetics, Dose-Response Relationship, Drug, Drug Tolerance, Healthy Volunteers, Safety
Abstract

The objectives of this phase I study are to assess the safety, tolerability, and pharmacokinetics (PKs) of RO7049389 in healthy Chinese volunteers (HVs) and evaluate potential ethnic differences in the safety and PKs using data from this study and the first-in-human study (in which most of the HVs were non-Asian). HVs randomly received a single dose of 200-600 mg of RO7049389 or a placebo in a single ascending dose (n = 28) or multiple doses of 200-400 mg of RO7049389 or a placebo in multiple ascending doses (n = 24). Safety and tolerability were monitored throughout the study. Serial blood samples were collected for PK analysis. RO7049389 was safe and well-tolerated in the HVs. The time to maximum concentration ranged from 1.5 to 3.0 h, and terminal half-life ranged from 3.66 to 14.6 h. A single dose of 200-600 mg and multiple doses of 200-400 mg exhibited nonlinear PKs. In general, the safety profiles were comparable between non-Asian and Asian HVs, but the plasma exposure of RO7049389 in Chinese HVs was higher than that in non-Asian HVs. The data generated from this study will provide guidance for future clinical studies on RO7049389 in Chinese/Asian patients with hepatitis B virus., (© 2021 Roche R&D Center China Ltd. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics.)

Published
2022
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