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

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

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 Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Biological: UB-313; Biological: Placebo

Detailed Description

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
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • Katholieke Universiteit Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Is a male or female aged 18 to 55 years old, inclusive, at time of informed consent.
• Has a body mass index between 18 and 30 kg/m2, inclusive at Screening, and with a minimum weight of 50 kg.
• Male participants and their partners of childbearing potential must commit to the use of highly effective contraceptives for the study duration and for at least 12 weeks after the last dose. Men must refrain from donating sperm during this same period.
• Female participants must be of nonchildbearing potential, or, for women of childbearing potential, must be willing to practice highly effective contraception throughout the duration of the study and for at least 24 weeks following the last dose.
• Other inclusion criteria apply

Exclusion Criteria:

• Has a history of clinically significant medical or psychiatric conditions, which in the opinion of the Investigator may compromise the participant's safety or the scientific value of the study, posing an unacceptable risk to the participant or interfere with the participant's ability to comply with study procedures or abide by study restrictions.
• Presents any concern by the Investigator regarding safe participation in the study or for any other reason (including contraindication to MRI) that the Investigator considers the participant inappropriate for participation in the study.
• Has a recent history (within the past year of Screening) of migraine headache.
• Has unsuitable skin characteristics for the dermal capsaicin challenge as determined by the Investigator.
• Has not demonstrated at least a 100% increase in dermal blood flow following capsaicin challenge as part of Screening procedures and measured through laser speckle contrast imaging.
• Other exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UB-313 Cohort 1; UB-313 100mcg administered by intramuscular (IM) injection at Week 0, Week 4 and Week 12	Biological: UB-313; A synthetic peptide-based immunotherapy
Experimental: UB-313 Cohort 2; UB-313 300mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12	Biological: UB-313; A synthetic peptide-based immunotherapy
Experimental: UB-313 Cohort 3; UB-313 300mcg administered by IM injection at Week 0, Week 4 and Week 12	Biological: UB-313; A synthetic peptide-based immunotherapy
Experimental: UB-313 Cohort 4; UB-313 600mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12	Biological: UB-313; A synthetic peptide-based immunotherapy
Placebo Comparator: Placebo Comparator; Placebo (normal saline), administered by IM injection at Week 0, Week 4 and Week 12	Biological: Placebo; Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events	The number and percentage of participants with TEAEs were tabulated.	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.	Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, 28, 36 and 44; Week 0, Week 16 and Week 44 are reported

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Weeks 0, 4, 8, 12, 16, 20

Collaborators and Investigators

• Sponsor: Vaxxinity, Inc.
• Investigators: Study Director: Medical Director, MD, Vaxxinity, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2022
• Primary Completion (Actual): October 6, 2023
• Study Completion (Actual): October 6, 2023

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: UB-313-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No