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A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-313 in Healthy Participants

NCT05477095 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-03-12

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

UB-313

A synthetic peptide-based immunotherapy

BIOLOGICAL

Placebo

Normal saline

Sponsors & Collaborators

  • Vaxxinity, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director, MD · Vaxxinity, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-06
Primary Completion
2023-10-06
Completion
2023-10-06

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05477095 on ClinicalTrials.gov