Trial Outcomes & Findings for A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-313 in Healthy Participants (NCT NCT05477095)
NCT ID: NCT05477095
Last Updated: 2025-03-12
Results Overview
The number and percentage of participants with TEAEs were tabulated.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
44 weeks
Results posted on
2025-03-12
Participant Flow
Participant milestones
| Measure |
UB-313 Cohort 1
UB-313 100mcg administered by intramuscular (IM) injection at Week 0, Week 4 and Week 12
UB-313: 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
UB-313: A synthetic peptide-based immunotherapy
|
UB-313 Cohort 3
UB-313 300mcg administered by IM injection at Week 0, Week 4 and Week 12
UB-313: 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
UB-313: A synthetic peptide-based immunotherapy
|
Placebo Comparator
Placebo (normal saline), administered by IM injection at Week 0, Week 4 and Week 12
Placebo: Normal saline
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-313 in Healthy Participants
Baseline characteristics by cohort
| Measure |
UB-313 Cohort 1
n=8 Participants
UB-313 100mcg administered by intramuscular (IM) injection at Week 0, Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
UB-313 Cohort 2
n=8 Participants
UB-313 300mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
UB-313 Cohort 3
n=8 Participants
UB-313 300mcg administered by IM injection at Week 0, Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
UB-313 Cohort 4
n=8 Participants
UB-313 600mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
Placebo Comparator
n=8 Participants
Placebo (normal saline), administered by IM injection at Week 0, Week 4 and Week 12
Placebo: Normal saline
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 13.66 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 8.52 • n=7 Participants
|
31.6 years
STANDARD_DEVIATION 11.92 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 7.87 • n=4 Participants
|
26.0 years
STANDARD_DEVIATION 8.88 • n=21 Participants
|
31.1 years
STANDARD_DEVIATION 10.32 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
BMI
|
25.39 kg/m2
STANDARD_DEVIATION 3.388 • n=5 Participants
|
23.58 kg/m2
STANDARD_DEVIATION 1.834 • n=7 Participants
|
24.29 kg/m2
STANDARD_DEVIATION 3.624 • n=5 Participants
|
21.88 kg/m2
STANDARD_DEVIATION 2.384 • n=4 Participants
|
23.68 kg/m2
STANDARD_DEVIATION 2.600 • n=21 Participants
|
23.76 kg/m2
STANDARD_DEVIATION 2.931 • n=8 Participants
|
PRIMARY outcome
Timeframe: 44 weeksThe number and percentage of participants with TEAEs were tabulated.
Outcome measures
| Measure |
UB-313 Cohort 1
n=8 Participants
UB-313 100mcg administered by intramuscular (IM) injection at Week 0, Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
UB-313 Cohort 2
n=8 Participants
UB-313 300mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
UB-313 Cohort 3
n=8 Participants
UB-313 300mcg administered by IM injection at Week 0, Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
UB-313 Cohort 4
n=8 Participants
UB-313 600mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
Placebo Comparator
n=8 Participants
Placebo (normal saline), administered by IM injection at Week 0, Week 4 and Week 12
Placebo: Normal saline
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
|
7 Participants
|
8 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, 28, 36 and 44; Week 0, Week 16 and Week 44 are reportedImmunogenicity measured by blood anti-CGRP antibody titers, reported as Optical Density (OD) of 1:25 dilution.
Outcome measures
| Measure |
UB-313 Cohort 1
n=7 Participants
UB-313 100mcg administered by intramuscular (IM) injection at Week 0, Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
UB-313 Cohort 2
n=8 Participants
UB-313 300mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
UB-313 Cohort 3
n=8 Participants
UB-313 300mcg administered by IM injection at Week 0, Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
UB-313 Cohort 4
n=8 Participants
UB-313 600mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
Placebo Comparator
n=8 Participants
Placebo (normal saline), administered by IM injection at Week 0, Week 4 and Week 12
Placebo: Normal saline
|
|---|---|---|---|---|---|
|
Immunogenicity Measured by Serum Anti-CGRP Antibodies.
Week 0 (Baseline)
|
0.5161 Optical Density (OD)
Standard Deviation 0.1697
|
0.4720 Optical Density (OD)
Standard Deviation 0.1688
|
0.6024 Optical Density (OD)
Standard Deviation 0.2292
|
0.5495 Optical Density (OD)
Standard Deviation 0.0994
|
0.4900 Optical Density (OD)
Standard Deviation 0.0862
|
|
Immunogenicity Measured by Serum Anti-CGRP Antibodies.
Week 16 (EoT)
|
2.7271 Optical Density (OD)
Standard Deviation 1.2042
|
2.1900 Optical Density (OD)
Standard Deviation 1.0378
|
3.2903 Optical Density (OD)
Standard Deviation 0.7628
|
3.0731 Optical Density (OD)
Standard Deviation 0.9075
|
0.4776 Optical Density (OD)
Standard Deviation 0.0861
|
|
Immunogenicity Measured by Serum Anti-CGRP Antibodies.
Week 44 (EoS)
|
1.4449 Optical Density (OD)
Standard Deviation 0.8055
|
1.2225 Optical Density (OD)
Standard Deviation 0.5760
|
1.7653 Optical Density (OD)
Standard Deviation 0.9176
|
1.5401 Optical Density (OD)
Standard Deviation 0.7779
|
0.5614 Optical Density (OD)
Standard Deviation 0.1321
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20Number of Participants with inhibition of capsaicin-induced increase in dermal blood flow
Outcome measures
| Measure |
UB-313 Cohort 1
n=7 Participants
UB-313 100mcg administered by intramuscular (IM) injection at Week 0, Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
UB-313 Cohort 2
n=8 Participants
UB-313 300mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
UB-313 Cohort 3
n=8 Participants
UB-313 300mcg administered by IM injection at Week 0, Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
UB-313 Cohort 4
n=8 Participants
UB-313 600mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
Placebo Comparator
n=8 Participants
Placebo (normal saline), administered by IM injection at Week 0, Week 4 and Week 12
Placebo: Normal saline
|
|---|---|---|---|---|---|
|
Pharmacodynamics of the Immune Response Measured by Capsaicin-induced Increase in Dermal Blood Flow
Baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pharmacodynamics of the Immune Response Measured by Capsaicin-induced Increase in Dermal Blood Flow
Week 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Pharmacodynamics of the Immune Response Measured by Capsaicin-induced Increase in Dermal Blood Flow
Week 16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Pharmacodynamics of the Immune Response Measured by Capsaicin-induced Increase in Dermal Blood Flow
Week 4
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pharmacodynamics of the Immune Response Measured by Capsaicin-induced Increase in Dermal Blood Flow
Week 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pharmacodynamics of the Immune Response Measured by Capsaicin-induced Increase in Dermal Blood Flow
Week 20
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
UB-313 Cohort 1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
UB-313 Cohort 2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
UB-313 Cohort 3
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
UB-313 Cohort 4
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo Comparator
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
UB-313 Cohort 1
n=8 participants at risk
UB-313 100mcg administered by intramuscular (IM) injection at Week 0, Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
UB-313 Cohort 2
n=8 participants at risk
UB-313 300mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
UB-313 Cohort 3
n=8 participants at risk
UB-313 300mcg administered by IM injection at Week 0, Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
UB-313 Cohort 4
n=8 participants at risk
UB-313 600mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12
UB-313: A synthetic peptide-based immunotherapy
|
Placebo Comparator
n=8 participants at risk
Placebo (normal saline), administered by IM injection at Week 0, Week 4 and Week 12
Placebo: Normal saline
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
25.0%
2/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
12.5%
1/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
50.0%
4/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
37.5%
3/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
25.0%
2/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
12.5%
1/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
25.0%
2/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
25.0%
2/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
25.0%
2/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
12.5%
1/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
37.5%
3/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
12.5%
1/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
25.0%
2/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
|
General disorders
General disorders and administration site conditions
|
50.0%
4/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
62.5%
5/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
62.5%
5/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
87.5%
7/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
25.0%
2/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
|
General disorders
Injection site pain
|
37.5%
3/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
50.0%
4/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
25.0%
2/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
87.5%
7/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
12.5%
1/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
|
General disorders
Fatigue
|
50.0%
4/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
25.0%
2/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
25.0%
2/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
37.5%
3/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
12.5%
1/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
|
Infections and infestations
Infections and infestations
|
50.0%
4/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
50.0%
4/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
75.0%
6/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
62.5%
5/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
62.5%
5/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
2/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
25.0%
2/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
37.5%
3/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
25.0%
2/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
12.5%
1/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
12.5%
1/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
12.5%
1/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
0.00%
0/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
50.0%
4/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
0.00%
0/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
0.00%
0/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
0.00%
0/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
25.0%
2/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
0.00%
0/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
12.5%
1/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
25.0%
2/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
12.5%
1/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
25.0%
2/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
12.5%
1/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
|
Nervous system disorders
Nervous system disorders
|
62.5%
5/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
50.0%
4/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
50.0%
4/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
75.0%
6/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
62.5%
5/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
|
Nervous system disorders
Headache
|
62.5%
5/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
50.0%
4/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
50.0%
4/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
62.5%
5/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
62.5%
5/8 • Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
|
Additional Information
Executive Director, Clinical Development
Vaxxinity, Inc.
Phone: 254-244-5739
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place