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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

NCT04925050 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2023-02-27

No results posted yet for this study

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

Interventions

DRUG

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

Matching Placebo for VB0004

Matching Placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-17
Primary Completion
2023-12-16
Completion
2024-01-23

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04925050 on ClinicalTrials.gov