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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
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
Secondary ID [1] 0 0
VXX-401-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of adverse events
Timepoint [1] 0 0
30 weeks
Primary outcome [2] 0 0
Immunogenicity
Timepoint [2] 0 0
Baseline to Week 16, 20, 24, and 30
Primary outcome [3] 0 0
Immunogenicity
Timepoint [3] 0 0
Baseline to Week 16, 20, 24, and 30
Primary outcome [4] 0 0
Determine optimal VXX-401 dose regimen
Timepoint [4] 0 0
Baseline to Week 16, 20, 24, and 30
Secondary outcome [1] 0 0
Evaluation of low-density lipoprotein-cholesterol (LDL-C) reduction
Timepoint [1] 0 0
Baseline to Week 16, 20, 24, and 30

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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/06/2024
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [2] 0 0
Sutherland Shire Clinical Research - Miranda
Recruitment hospital [3] 0 0
Emeritus Research - Sydney
Recruitment hospital [4] 0 0
University of the Sunshine Coast (USC) - Morayfield
Recruitment hospital [5] 0 0
Emeritus Research - Melbourne
Recruitment postcode(s) [1] 0 0
- Brookvale
Recruitment postcode(s) [2] 0 0
- Miranda
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
- Morayfield
Recruitment postcode(s) [5] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vaxxinity, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05762276
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sasha Rumyantsev
Address 0 0
Vaxxinity, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries