Han, Lyrialle W.
Jamalian, Samira
Hsu, Joy C.
Sheng, X. Rebecca
Yang, Xiaoyun
Yang, Xiaoying
Monemi, Sharareh
Hassan, Sharmeen
Yadav, Rajbharan
Tuckwell, Katie
Kunder, Rebecca
Pan, Lin
Glickstein, Sara
Clinical trials referenced in this document:
Documents that mention this clinical trial
POS1266 A PHASE IA, RANDOMIZED STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ASCENDING DOSES OF RO7303509, AN ANTI-TGFΒ3 MONOCLONAL ANTIBODY, IN HEALTHY VOLUNTEERS
https://doi.org/10.1136/annrheumdis-2023-eular.487
A Phase 1a Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7303509, an Anti-TGFβ3 Antibody, in Healthy Volunteers
https://doi.org/10.1007/s40744-024-00670-5
Funding for this research was provided by:
Genentech
Article History
Received: 2 February 2024
Accepted: 22 March 2024
First Online: 25 April 2024
Declarations
:
: At the time this work was performed, all authors (Lyrialle W Han, Samira Jamalian, Joy C. Hsu, X. Rebecca Sheng, Xiaoyun Yang, Xiaoying Yang, Sharareh Monemi, Sharmeen Hassan, Rajbharan Yadav, Katie Tuckwell, Rebecca Kunder, Lin Pan, Sara Glickstein) were employees of Genentech, Inc., a member of the Roche group, and owned Roche stock and/or options. Rebecca Kunder is now an employee of IGM Biosciences, Inc. Katie Tuckwell is now an employee of Regeneron Pharmaceuticals, Inc.
: The clinical study protocol and associated documents were approved by an Institutional Review Board (Advarra IRB, reference number: GA42285) before study initiation. The study was conducted in full conformance with the ICH E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki. The study complied with the requirements of the ICH E2A guideline (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting) and the U.S. FDA regulations and applicable local, state, and federal laws. All participants provided written, informed consent before enrolling in the study.