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

NCT ID: NCT05477095

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-06
• Study Completion Date: 2023-10-06

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.

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

UB-313 Cohort 1

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

Group Type: EXPERIMENTAL

UB-313

Intervention Type: BIOLOGICAL

A synthetic peptide-based immunotherapy

UB-313 Cohort 2

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

Group Type: EXPERIMENTAL

UB-313

Intervention Type: BIOLOGICAL

A synthetic peptide-based immunotherapy

UB-313 Cohort 3

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

Group Type: EXPERIMENTAL

UB-313

Intervention Type: BIOLOGICAL

A synthetic peptide-based immunotherapy

UB-313 Cohort 4

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

Group Type: EXPERIMENTAL

UB-313

Intervention Type: BIOLOGICAL

A synthetic peptide-based immunotherapy

Placebo Comparator

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Normal saline

Interventions

UB-313

A synthetic peptide-based immunotherapy

Intervention Type: BIOLOGICAL

Placebo

Normal saline

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vaxxinity, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director, MD

Role: STUDY_DIRECTOR

Vaxxinity, Inc.

Locations

Katholieke Universiteit Leuven

Leuven, , Belgium

Countries

Belgium

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

UB-313-101

Identifier Type: -

Identifier Source: org_study_id