Trial status
RECRUITMENT
At the time of manuscript submission, the protocols for IB1001-301 (US V1.2 07-Jan-2022; Global: V2.0, 08-Mar-2022; Swiss V2.1 14-Jul-2022) have been accepted/approved in each country where the study will be conducted, including the US Food and Drug Administrations, UK Medicines and Healthcare products Regulatory Authority, German Federal Institute for Drugs and Medical Devices, Slovakia Štátny ústav pre kontrolu liečiv, Switzerland Swissmedic, Netherlands Central Committee on Research Involving Human Subjects, Czech Republic State Institute for Drug Control, and Australia Therapeutic Goods Administration as well as respective research ethics committees (REC)/institutional review boards (IRB) (active approved protocol version varies based on status of enrollment per site/per study). The first study participant was enrolled on 30 June 2022. Recruitment is ongoing and expected to complete December 2022.