CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
UB-313 +1 morebiological
Likely dose
UB-313 dose not specified in interventions or armsAI-extracted
Key inclusion· 4
  • ✓Age 18 to 55 years old at time of informed consent
  • ✓BMI between 18 and 30 kg/m² with minimum weight of 50 kg
  • ✓Male participants and partners must use highly effective contraception for study duration plus 12 weeks after last dose; men must not donate sperm
  • ✓Female participants of nonchildbearing potential, or if of childbearing potential, must practice highly effective contraception through study and for 24 weeks after last dose
Key exclusion· 5
  • ✕History of clinically significant medical or psychiatric conditions that may compromise safety or scientific value, or pose unacceptable risk
  • ✕Any concern by Investigator regarding safe participation, including contraindication to MRI
  • ✕Recent history of migraine headache within the past year of Screening
  • ✕Unsuitable skin characteristics for dermal capsaicin challenge as determined by Investigator

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05477095
NCT05477095Phase 1Completed
CompareCT.gov

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Immunogenicity of UBITh® CGRP Immunotherapy (UB-313) in Healthy Participants

Vaxxinity, Inc.·interventional·Posted Jul 28, 2022·Updated Mar 12, 2025

In Brief

A Phase 1 clinical trial evaluating UB-313 and Placebo for Migraine. Completed, enrolled 40 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesBelgium
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedJul 28, 2022
Enrollment StartJul 6, 2022
Primary CompletionOct 6, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.9 years ago

Interventions

UB-313biological

A synthetic peptide-based immunotherapy

Placebobiological

Normal saline