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First-in-Human Study of VB0004 in Healthy Subjects and to Patients With Mild to Moderate Hypertension With Low Cardiovascular Risk
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.
Study details:
Part A - SAD Cohorts 1 to 5:. Part 1 will consist of up to 5 cohorts (1 cohort per dose level). Each cohort will include 8 subjects (6 subjects receiving the active study drug and 2 subjects receiving matching placebo), for a total of 40 subjects.
Efforts will be made to have gender-balanced cohorts. A staggered dosing schedule will be used for dosing of each cohort and will include 2 sentinel subjects (1 active and 1 placebo) dosed initially, and the remaining 6 subjects dosed at least 24 hours later. Following completion of each dose level, a Safety Monitoring Committee (SMC) will review the safety and tolerability data, as well as available PK data up to the Follow-Up Visit (Day 8), for at least 6 subjects in the respective cohort, in order to make decisions whether to escalate to the next dose level, decrease the next dose level, repeat a dose level, or to not evaluate any additional dose.
The FE study will be conducted with 2 cohorts of 8 healthy participants from the SAD study. Subjects from FE Cohort 3 and, if needed, Cohort 4 will receive the study drug under both fasting (in a first period) and fed conditions (in a second period). There will be a washout period of at least 14 days between dosing of the fasting and the fed periods.
Safety, tolerability, and PK data through at least to the Follow-Up Visit (Day 8), from a subsequent cohort will be reviewed by the SMC prior to dosing the fed period of FE Cohort. Therefore, the fed period of a FE Cohort could be dosed in parallel of the SAD Cohort receiving two doses higher. The planned SAD dose range is anticipated to be from 2 mg to 300 mg.
Part B - MAD Cohorts 6 to 8 (Healthy Volunteers):. Part B will consist of 3 cohorts (1 cohort per dose level). Each cohort will include 8 subjects (6 subjects receiving the study drug and 2 subjects receiving matching placebo daily for 14 consecutive days), for a total of 24 subjects.
Efforts will be made to have gender-balanced cohorts. Part B can be initiated only following review of the safety, tolerability, and PK data following dosing of the SAD Cohort 3 or 4. A staggered dosing schedule might be used for the first dose level, including 2 sentinel subjects (1 active and 1 placebo) initiating dosing first and the remaining 6 subjects initiating dosing at least 24 hours later.
Following completion of each dose level, a SMC will review the safety and tolerability data, as well as available PK data for at least 6 subjects in the respective cohort, in order to make decisions whether to escalate to the next dose level, decrease the next dose level, repeat a dose level, or to not evaluate any additional dose. The planned MAD dose range is anticipated to be from 10 mg to 100 mg administered q. d.
for 14 consecutive days. Part C - MAD Cohorts 9 and 10 (Patients with mild to moderate hypertension): Part C will consist of 2 cohorts (1 cohort per dose level). Each cohort will include a maximum of 8 patients with mild to moderate hypertension with low cardiovascular risk (6 subjects receiving the study drug and 2 subjects receiving matching placebo daily for 28 consecutive days), for a total of 16 patients.
The doses of VB0004 administered will be determined by the SAD and MAD PK data. Following completion of Cohort 9, a SMC will review the safety and tolerability data, as well as available PK data for at least 6 subjects in the respective cohort, in order to make decisions whether to escalate to the next dose level, decrease the next dose level, repeat a dose level, or to not evaluate any additional dose.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-06-17
Primary completion: 2023-12-16
Study completion finish: 2024-01-23
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT04925050
Intervention or treatment
DRUG: VB0004
OTHER: Matching Placebo for VB0004
Conditions
- • Hypertension
Find a site
Closest Location:
Nucleus Network Pty Ltd
Research sites nearby
Select from list below to view details:
Nucleus Network Pty Ltd
Victor Harbor, Melbourne, Australia
Scientia Clinical Research
Randwick, New South Whales, Australia
Nucleus Network Pty Ltd Geelong Site
Geelong, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
ACTIVE_COMPARATOR: Drug VB0004
| DRUG: VB0004
|
PLACEBO_COMPARATOR: Placebo
| OTHER: Matching Placebo for VB0004
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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. | Adverse events observed during single ascending dose (SAD) and multiple ascending dose (MAD) studies | Upto Day 21 after each study vaccination |
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 | Patients with mild to moderate hypertension (Blood pressure \[BP\] 140-15/90-99) will be used to evaluate the safety and tolerability of VB0004. | Upto Day 35 after each study vaccination |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Calculation of the area under the plasma concentration-time curve for VB0004 to define the pharmacokinetic profile of VB0004 in healthy volunteers. | Both single and multiple doses of VB0004 will be used to define the pharmacokinetic profile of VB0004 from zero time to last measurable concentration | Up to Day 28 |
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. | Both single and multiple doses of VB0004 will be used to define the pharmacokinetic profile of VB0004 from zero time to last measurable concentration | Up to Day 30 |
Comparison of the area under the plasma concentration-time curve for VB0004 in both fed and fasted states. | Both the fed and fasted states will be used to define whether food intake affects absorption and/or metabolism VB0004 from zero time to last measurable concentration | Up to Day 28 |
Frequently Asked Questions
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