Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05762276
Registration number
NCT05762276
Ethics application status
Date submitted
20/02/2023
Date registered
9/03/2023
Date last updated
12/10/2023
Titles & IDs
Public title
A Study to Investigate the Safety, Tolerability, Immunogenicity, and Pharmacodynamics of VXX-401 Administered IM in Adult Participants
Query!
Scientific title
A Phase 1, First-in-Human, Dose Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacodynamics of VXX-401 in Healthy Adults
Query!
Secondary ID [1]
0
0
VXX-401-101
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia
0
0
Query!
Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
Query!
Other metabolic disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - VXX-401
Other interventions - Placebo
Experimental: VXX-401 Cohort A - VXX-401 100mcg administered by intramuscular (IM) injection at Week 0, Week 4, and Week 12
Experimental: VXX-401 Cohort B - VXX-401 100mcg administered by intramuscular (IM) injection at Week 0, Week 4, Week 8 and Week 12
Experimental: VXX-401 Cohort C - VXX-401 300mcg administered by intramuscular (IM) injection at Week 0, Week 4, and Week 12
Experimental: VXX-401 Cohort D - VXX-401 300mcg administered by intramuscular (IM) injection at Week 0, Week 4, Week 8 and Week 12
Placebo Comparator: Placebo Cohort A and C - Placebo administered by intramuscular (IM) injection at Week 0, Week 4, and Week 12
Placebo Comparator: Placebo Cohort B and D - Placebo administered by intramuscular (IM) injection at Week 0, Week 4, Week 8 and Week 12
Experimental: VXX-401 Cohort E - VXX-401 900mcg administered by intramuscular (IM) injection at Week 0. VXX-401 100 mcg administered by intramuscular (IM) injection at Week 4 and Week 12.
Experimental: VXX-401 Cohort F - VXX-401 900mcg administered by intramuscular (IM) injection at Week 0. VXX-401 300 mcg administered by intramuscular (IM) injection at Week 4 and Week 12.
Treatment: Drugs: VXX-401
A synthetic PCSK9 peptide-based immunotherapy
Other interventions: Placebo
Normal saline
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Frequency of adverse events
Query!
Assessment method [1]
0
0
Safety and tolerability: rates of adverse events (AEs), medically attended adverse events (MAAEs), local (injection site) and systemic (generalized) reactions (i.e., reactogenicity), clinical laboratory assessments (e.g., chemistry, hematology, urinalysis, lipid profile), serum cytokine release, vital signs, physical examinations, and electrocardiograms (ECGs) through the end of the study.
Query!
Timepoint [1]
0
0
30 weeks
Query!
Primary outcome [2]
0
0
Immunogenicity
Query!
Assessment method [2]
0
0
Immunogenicity will be measured by serum anti-PCSK9 antibody titers
Query!
Timepoint [2]
0
0
Baseline to Week 16, 20, 24, and 30
Query!
Primary outcome [3]
0
0
Immunogenicity
Query!
Assessment method [3]
0
0
Seroconversion two-fold and four-fold from baseline
Query!
Timepoint [3]
0
0
Baseline to Week 16, 20, 24, and 30
Query!
Primary outcome [4]
0
0
Determine optimal VXX-401 dose regimen
Query!
Assessment method [4]
0
0
Measured by serum anti-PCSK9 antibody titers
Query!
Timepoint [4]
0
0
Baseline to Week 16, 20, 24, and 30
Query!
Secondary outcome [1]
0
0
Evaluation of low-density lipoprotein-cholesterol (LDL-C) reduction
Query!
Assessment method [1]
0
0
Percent change from baseline in serum LDL-C concentration
Query!
Timepoint [1]
0
0
Baseline to Week 16, 20, 24, and 30
Query!
Eligibility
Key inclusion criteria
1. Male or female participants aged 18 to 75 years old, inclusive, at time of informed
consent.
2. LDL-C level = 2.59 mmol/L - 4.89mmol/L
3. Body mass index between 18 and 35 kg/m2, inclusive at Screening, and with a minimum
weight of 50 kg.
4. 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.
5. Female participants must be of nonchildbearing potential, or, for women of
childbearing potential, must be willing to practice at least one form of highly
effective contraception throughout the duration of the study and for at least 24 weeks
following the last dose. Female participants must refrain from donating reproductive
tissue during this same period.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
1. Subjects considered high risk or very high risk for ASCVD and requiring immediate
treatment with LLT according to the clinical judgement of the investigator.
2. History of confirmed anergy (i.e., not able to mount an immunological response) or
history of immunization failure in the 5 years prior to the Screening Visit.
3. Presence of fever >38°C or other signs or symptoms of acute disease within 1 week
before the Screening and/or Visit 1; Screening and/or Visit 1 may be rescheduled at
the discretion of the Investigator but must occur within the 4-week window.
4. Known disturbance of coagulation or medication (see prohibited medications criterion
below); bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet
disorder), or prior history of significant bleeding or bruising following IM
injections or venipuncture.
5. Triglycerides > 5.65 mmol/L
6. Has a history of clinically significant medical disorder or psychiatric conditions,
which in the opinion of the investigator may compromise the participant's safety and
ability to comply with study procedures or abide by study restrictions.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
7/03/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
27/06/2024
Query!
Actual
Query!
Sample size
Target
64
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Northern Beaches Clinical Research - Brookvale
Query!
Recruitment hospital [2]
0
0
Sutherland Shire Clinical Research - Miranda
Query!
Recruitment hospital [3]
0
0
Emeritus Research - Sydney
Query!
Recruitment hospital [4]
0
0
University of the Sunshine Coast (USC) - Morayfield
Query!
Recruitment hospital [5]
0
0
Emeritus Research - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
- Brookvale
Query!
Recruitment postcode(s) [2]
0
0
- Miranda
Query!
Recruitment postcode(s) [3]
0
0
- Sydney
Query!
Recruitment postcode(s) [4]
0
0
- Morayfield
Query!
Recruitment postcode(s) [5]
0
0
- Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Vaxxinity, Inc.
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Novotech (Australia) Pty Limited
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This first-in-human (FIH) study of VXX-401, an anti-PCSK9 peptide-based immunotherapeutic
candidate, is designed to assess the safety, tolerability, immunogenicity, and
pharmacodynamics (PD) of VXX-401 and to determine an optimal dose regimen for LDL-C lowering
in subsequent clinical trials.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05762276
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Sasha Rumyantsev
Query!
Address
0
0
Vaxxinity, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05762276
Download to PDF