Launch of the U.S. Phase I/II Clinical Trial of SI-722
First written in FY2020-Q2. 3 of 6 entries say "Advanced", first in FY2021-Q2. Latest entry: FY2021.
No other company in this theme has enough history to compare yet.
- FY2021AdvancedAnnual report
「The Phase I/II clinical trial being conducted in the United States was delayed as a result of the spread of COVID-19, but subject enrollment was completed in January 2021, and tolerability was confirmed in the trial. Based on the data obtained, we are currently considering the next-phase trial.」
Despite delays caused by COVID-19, SI-722 completed subject enrollment in January 2021, confirmed tolerability, its primary objective, and advanced to the stage of considering the next-phase trial. - FY2021-Q3AdvancedAnnual report
「The Phase I/II clinical trial began in November 2019, and although the trial schedule was delayed by the spread of COVID-19 in the United States, subject enrollment was completed in January 2021.」
Despite trial delays caused by the spread of COVID-19, subject enrollment in the Phase I/II clinical trial of SI-722 was completed in January 2021. - FY2021-Q2AdvancedAnnual report
「The Phase I/II clinical trial began in November 2019, but the trial schedule was delayed by the spread of COVID-19 in the United States. Through the first quarter, when infections were increasing, the trial was affected by interruptions at medical institutions and restrictions on patient visits. However, as economic activity resumed, all trial sites were operational as of the end of September 2020. Subject enrollment is currently proceeding in cooperation with the local contract research organization.」
Although SI-722 was delayed relative to the trial schedule, all trial sites were operational as of the end of September 2020, and the program had advanced to the stage of enrolling subjects in cooperation with the local contractor. - FY2021-Q1SoftenedAnnual report
「The Phase I clinical trial in the United States was completed and the Phase I/II clinical trial began in November 2019. However, due to the spread of COVID-19, as of the end of June 2020, a delay of approximately 4 months was expected relative to the trial plan. If infections in the United States spread further and a lockdown is imposed in a state where a trial site is located, subject enrollment may be affected. We are currently working with our local contract research organization to conduct the trial while giving the highest priority to the situation in the healthcare setting and preventing infection among patients and healthcare professionals.」
The U.S. Phase I/II trial of SI-722 was expected to be delayed by approximately 4 months relative to the trial plan due to the spread of COVID-19. The company was working with its local contractor to continue the trial. - FY2020SoftenedAnnual report
「In addition, the spread of COVID-19 in the United States has delayed the trial plan. We are currently collecting and reviewing local information, and once the situation has settled, we plan to focus on enrolling subjects and reconsider the trial plan.」
After SI-722 entered the Phase I/II trial in November 2019, the trial plan was delayed by the spread of COVID-19. - FY2020-Q2First statedAnnual report
「SI-722 (treatment for interstitial cystitis; development region: United States): The Phase I clinical trial in the United States was completed, and the Phase I/II clinical trial began in November 2019. In this trial, safety, tolerability and pharmacokinetics, as well as exploratory efficacy, will be evaluated.」
For SI-722, a treatment for interstitial cystitis, the U.S. Phase I trial was completed and the Phase I/II trial began in November 2019. The program advanced to the stage of evaluating safety, tolerability, pharmacokinetics and efficacy.