First-in-Human Study of VB0004 in Healthy Subjects and to Patients With Mild to Moderate Hypertension With Low Cardiovascular Risk

NCT04925050 | Unknown Phase 1

• 1 other identifier: VB004-001
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Calculation of the area under the plasma concentration-time curve for VB0004 to define the pharmacokinetic profile of VB0004 in healthy volunteers.

  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.

  Up to Day 30

• Comparison of the area under the plasma concentration-time curve for VB0004 in both fed and fasted states.

  Up to Day 28

Other Outcomes (3)

• Troponin will be measured in plasma as well as blood pressure in supine and standing positions.

  Up to 27 days post dose

• Creatinine will be measured in plasma as well as blood pressure in supine and standing positions.

  Up to 27 days post dose

• Cystatin C will be measured in plasma as well as blood pressure in supine and standing positions.

  Up to 27 days post dose

Study Arms (2)

Drug VB0004

ACTIVE COMPARATOR

Experimental, Single Ascending dose , Multiple Ascending dose in healthy subjects and naive patients with mild or moderate hypertension with low cardiovascular risk

Drug: VB0004

Placebo

PLACEBO COMPARATOR

Matching Placebo for VB0004

Other: Matching Placebo for VB0004

Interventions

VB0004 DRUG

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.

Drug VB0004

Matching Placebo for VB0004 OTHER

Matching Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Syneos Health: lead

Study Sites (3)

Nucleus Network Pty Ltd

Victor Harbor, Melbourne, 3004, Australia

RECRUITING

Scientia Clinical Research

Randwick, New South Whales, 2031, Australia

NOT YET RECRUITING

Nucleus Network Pty Ltd Geelong Site

Geelong, Victoria, 3220, Australia

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Recruitment Officer

CONTACT

1800 243 733; Recruitment@nucleusnetwork.com.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 14, 2021
• Study Start: June 17, 2021
• Primary Completion: December 16, 2023
• Study Completion: January 23, 2024
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)