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

NCT05477095 | Completed Phase 1 Results

• 1 other identifier: UB-313-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Migraine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Pharmacodynamics of the Immune Response Measured by Capsaicin-induced Increase in Dermal Blood Flow

  Weeks 0, 4, 8, 12, 16, 20

Study Arms (5)

UB-313 Cohort 1

EXPERIMENTAL

UB-313 100mcg administered by intramuscular (IM) injection at Week 0, Week 4 and Week 12

Biological: UB-313

UB-313 Cohort 2

EXPERIMENTAL

UB-313 300mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12

Biological: UB-313

UB-313 Cohort 3

EXPERIMENTAL

UB-313 300mcg administered by IM injection at Week 0, Week 4 and Week 12

Biological: UB-313

UB-313 Cohort 4

EXPERIMENTAL

UB-313 600mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12

Biological: UB-313

Placebo Comparator

PLACEBO COMPARATOR

Placebo (normal saline), administered by IM injection at Week 0, Week 4 and Week 12

Biological: Placebo

Interventions

UB-313 BIOLOGICAL

A synthetic peptide-based immunotherapy

UB-313 Cohort 1; UB-313 Cohort 2; UB-313 Cohort 3; UB-313 Cohort 4

Placebo BIOLOGICAL

Normal saline

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vaxxinity, Inc.: lead

Study Sites (1)

Katholieke Universiteit Leuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Executive Director, Clinical Development
• Organization: Vaxxinity, Inc.

info@vaxxinity.com

254-244-5739

Study Officials

• Medical Director, MD

  Vaxxinity, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 28, 2022
• Study Start: July 6, 2022
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)