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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/NCT04925050




Registration number
NCT04925050
Ethics application status
Date submitted
21/05/2021
Date registered
14/06/2021
Date last updated
27/02/2023

Titles & IDs
Public title
First-in-Human Study of VB0004 in Healthy Subjects and to Patients With Mild to Moderate Hypertension With Low Cardiovascular Risk
Scientific title
A Phase I/IB, First-Time-in-Human, Single Centre, Double-Blind, Randomized, Placebo-controlled, Dose Escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of VB0004 Administered Orally to Healthy Volunteers; and to Patients With Mild to Moderate Hypertension With Low Cardiovascular Risk.
Secondary ID [1] 0 0
VB004-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VB0004
Other interventions - Matching Placebo for VB0004

Active Comparator: Drug VB0004 - Experimental, Single Ascending dose , Multiple Ascending dose in healthy subjects and naive patients with mild or moderate hypertension with low cardiovascular risk

Placebo Comparator: Placebo - Matching Placebo for VB0004


Treatment: Drugs: VB0004
Each study part (A,B and C) will be completed sequentially or with partial overlapping. Safety and PK data through at least day 8 from a subsequent cohort will be reviewed by the SMC prior to dosing the fed period of FE cohort. Safety data will be assessed by SMC after completing each cohorts in MAD healthy volunteers and MAD mild Hypertension patients.

Other interventions: Matching Placebo for VB0004
Matching Placebo
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
The occurrence and severity of treatment related adverse events as defined in CTCAE v4.0 to evaluate the safety and tolerability of VB0004 in healthy volunteers.
Timepoint [1] 0 0
Upto Day 21 after each study vaccination
Primary outcome [2] 0 0
The occurrence and severity of treatment related adverse events as defined in CTCAE v4.0 which are observed during treatment with repeated doses of VB0004
Timepoint [2] 0 0
Upto Day 35 after each study vaccination
Secondary outcome [1] 0 0
Calculation of the area under the plasma concentration-time curve for VB0004 to define the pharmacokinetic profile of VB0004 in healthy volunteers.
Timepoint [1] 0 0
Up to Day 28
Secondary outcome [2] 0 0
Calculation of the area under the plasma concentration-time curve for VB0004 to define the pharmacokinetic profile of VB0004 in patients with mild to moderate hypertension and low cardiovascular risk.
Timepoint [2] 0 0
Up to Day 30
Secondary outcome [3] 0 0
Comparison of the area under the plasma concentration-time curve for VB0004 in both fed and fasted states.
Timepoint [3] 0 0
Up to Day 28

Eligibility
Key inclusion criteria
- Male or female, non-smoker (no use of tobacco or nicotine products within 1 month
prior to screening), =18 and =55 years of age, with BMI >18.0 and <32.0 kg/m2.

- Male subjects who are not vasectomized for at least 6 months, and who are sexually
active with a female partner of childbearing potential (childbearing potential females
are defined as women that are neither post-menopausal nor surgically sterile) must be
willing to use one of the following acceptable contraceptive methods from (the first)
study drug administration and for 90 days after (the last) study drug administration:

1. simultaneous use of a male condom and, for the female partner, oral
contraceptives containing combined estrogen and progesterone beginning a least 4
weeks prior to screening, a vaginal ring, injectable and implantable hormonal
contraceptives, intrauterine hormone-releasing system (e.g. Mirena), and
progestogen-only hormonal contraception associated with inhibition of ovulation,
placed at least 4 weeks prior to the first study drug administration.

2. simultaneous use of a male condom and, for the female partner, nonhormonal
intrauterine device (IUD) placed at least 4 weeks prior to the first study drug.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any laboratory test results deemed clinically significant by the Investigator or
positive test for HIV, HBsAg, or HCV.

- Clinically significant ECG abnormalities or vital sign abnormalities (systolic BP
lower than 90 or over 140 mmHg (except for hypertensive patients), diastolic BP lower
than 40 or over 90 mmHg, HR less than 40 or over 100 bpm, or RR less than 10 or over
22 bpm) at screening.

- Orthostatic hypotension at Screening or Day -1 (Systolic BP falls > 20 mm Hg or
Diastolic BP falls > 10 mm Hg on standing)

- History of significant alcohol abuse within 1 year prior to screening or regular use
of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol
per week [1 unit = 375 mL of beer 3.5%, 100 mL of wine 13.5%, or 30 mL of distilled
alcohol 40%]).

- Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding
volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than
499 mL within 56 days prior to the first dosing.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/01/2024
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
MelbourneNew South WhalesVIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Victor Harbor
Recruitment hospital [2] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [3] 0 0
Nucleus Network Pty Ltd Geelong Site - Geelong
Recruitment postcode(s) [1] 0 0
3004 - Victor Harbor
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
3220 - Geelong

Funding & Sponsors
Primary sponsor type
Other
Name
Syneos Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This will be a single center, Phase I/IB, randomized, double-blind, placebo-controlled,
sequential SAD/MAD/FE study, with a patients arm.

The study will be divided into three parts:

Part A: SAD cohorts, with FE evaluation Part B: MAD cohorts with healthy volunteers Part C:
MAD cohorts including naïve patients with mild to moderate hypertension and low
cardiovascular risk The three parts will be completed sequentially or with partial
overlapping.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04925050
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Recruitment Officer
Address 0 0
Country 0 0
Phone 0 0
1800 243 733
Fax 0 0
Email 0 0
Recruitment@nucleusnetwork.com.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04925050