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

Phase 1

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
UB-313 Cohort 2	UB-313	UB-313 300mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12
Placebo Comparator	Placebo	Placebo (normal saline), administered by IM injection at Week 0, Week 4 and Week 12
UB-313 Cohort 3	UB-313	UB-313 300mcg administered by IM injection at Week 0, Week 4 and Week 12
UB-313 Cohort 1	UB-313	UB-313 100mcg administered by intramuscular (IM) injection at Week 0, Week 4 and Week 12
UB-313 Cohort 4	UB-313	UB-313 600mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events	44 weeks	The number and percentage of participants with TEAEs were tabulated.
Immunogenicity Measured by Serum Anti-CGRP Antibodies.	Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, 28, 36 and 44; Week 0, Week 16 and Week 44 are reported	Immunogenicity measured by blood anti-CGRP antibody titers, reported as Optical Density (OD) of 1:25 dilution.

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics of the Immune Response Measured by Capsaicin-induced Increase in Dermal Blood Flow	Weeks 0, 4, 8, 12, 16, 20	Number of Participants with inhibition of capsaicin-induced increase in dermal blood flow