Vaxxinity, Inc is recruiting patients for the clinical trial of A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-313 in Healthy Participants.
This first in-human (FIH) study of UB-313, an anti-calcitonin gene-related peptide based immunotherapeutic candidate, is designed to assess the safety, tolerability, and immunogenicity of 4 selected UB-313 dose regimens in healthy adults.
All eligible participants will be enrolled in the study for up to 44 weeks, consisting of IM injections of UB-313 or placebo at Week 0 (Baseline, Day 1), Week 4, and Week 12. The End of Treatment (EoT) is defined as Week 16, followed by a follow-up period up to Week 44.
The researchers plan that July 6, 2022 will be the study start date. The indicative completion of the clinical trial will be expected in August 2023.
Among primary outcome measures are the Immunogenicity will be measured by serum anti-CGRP antibodies in blood and Immunogenicity will be measured by change from baseline of blood anti-CGRP antibody titers.
The study will take place at the Katholieke Universiteit Leuven, Leuven, Belgium.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05477095.