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.
This is a single-site, randomized, double-blind, placebo-controlled, multidose regimen, FIH study of UB-313, an anti-CGRP peptide-based immunotherapy candidate. The double-blind period will include dose escalation and cohort staggering for up to 4 planned dose levels of UB-313 or placebo in 4 cohorts of healthy participants. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
40
Katholieke Universiteit Leuven
Leuven, Belgium
Number of Participants With Treatment-Emergent Adverse Events
The number and percentage of participants with TEAEs were tabulated.
Time frame: 44 weeks
Immunogenicity Measured by Serum Anti-CGRP Antibodies.
Immunogenicity measured by blood anti-CGRP antibody titers, reported as Optical Density (OD) of 1:25 dilution.
Time frame: Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, 28, 36 and 44; Week 0, Week 16 and Week 44 are reported
Pharmacodynamics of the Immune Response Measured by Capsaicin-induced Increase in Dermal Blood Flow
Number of Participants with inhibition of capsaicin-induced increase in dermal blood flow
Time frame: Weeks 0, 4, 8, 12, 16, 20
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