Study of UB-312 in Healthy Participants and Parkinson's Disease Patients

Summary

This is a 44-week, randomized, placebo-controlled, double-blind, single-center, phase 1 clinical trial consisting of a dose-escalation Part A study in healthy participants, followed by a Part B in participants with Parkinson's disease with a selected doses from Part A.

Timeline

Start

2019-08-29

Primary completion

2023-03-01

Completion

2023-03-01

Publications

• Background Wang CY, Walfield AM. Site-specific peptide vaccines for immunotherapy and immunization against chronic diseases, cancer, infectious diseases, and for veterinary applications. Vaccine. 2005 Mar 18;23(17-18):2049-56. doi: 10.1016/j.vaccine.2005.01.007.
• Background Wang CY, Finstad CL, Walfield AM, Sia C, Sokoll KK, Chang TY, Fang XD, Hung CH, Hutter-Paier B, Windisch M. Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease. Vaccine. 2007 Apr 20;25(16):3041-52. doi: 10.1016/j.vaccine.2007.01.031. Epub 2007 Jan 19.
• Background Wang CY, Wang PN, Chiu MJ, Finstad CL, Lin F, Lynn S, Tai YH, De Fang X, Zhao K, Hung CH, Tseng Y, Peng WJ, Wang J, Yu CC, Kuo BS, Frohna PA. UB-311, a novel UBITh(R) amyloid beta peptide vaccine for mild Alzheimer's disease. Alzheimers Dement (N Y). 2017 Apr 14;3(2):262-272. doi: 10.1016/j.trci.2017.03.005. eCollection 2017 Jun.
• Results Eijsvogel P, Misra P, Concha-Marambio L, Boyd JD, Ding S, Fedor L, Hsieh YT, Sun YS, Vroom MM, Farris CM, Ma Y, de Kam ML, Radanovic I, Vissers MFJM, Mirski D, Shareghi G, Shahnawaz M, Singer W, Kremer P, Groeneveld GJ, Yu HJ, Dodart JC. Target engagement and immunogenicity of an active immunotherapeutic targeting pathological alpha-synuclein: a phase 1 placebo-controlled trial. Nat Med. 2024 Sep;30(9):2631-2640. doi: 10.1038/s41591-024-03101-8. Epub 2024 Jun 20.
• Results Yu HJ, Thijssen E, van Brummelen E, van der Plas JL, Radanovic I, Moerland M, Hsieh E, Groeneveld GJ, Dodart JC. A Randomized First-in-Human Study With UB-312, a UBITh(R) alpha-Synuclein Peptide Vaccine. Mov Disord. 2022 Jul;37(7):1416-1424. doi: 10.1002/mds.29016. Epub 2022 Apr 15.

Drugs

Indications