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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/NCT04680026




Registration number
NCT04680026
Ethics application status
Date submitted
17/12/2020
Date registered
22/12/2020
Date last updated
28/02/2024

Titles & IDs
Public title
A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)
Scientific title
A Phase 2, Two-Stage, Serial Cohort Dose Escalation and Expansion Study of a Single Intravenous Infusion of HBI 3000 for the Conversion of Atrial Fibrillation (AF) of Recent Onset
Secondary ID [1] 0 0
HBI-3000-402
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HBI-3000
Treatment: Drugs - Placebo

Experimental: Drug: HBI-3000, Stage A Dose Level 1 - Stage A Open Label HBI-3000 Dose Level 1: 200 mg

Experimental: Drug: HBI-3000, Stage A Dose Level 2 - Stage A Open Label HBI-3000 Dose Level 2: 350 mg planned

Experimental: Drug: HBI-3000, Stage A Dose Level 3 - Stage A Open Label HBI-3000 Dose Level 2: 500 mg planned

Experimental: Drug: HBI-3000, Stage B Dose Level 1 - Stage B Double-blind placebo controlled, Cohort 1 HBI-3000 Dose Level 1: Selected based on Stage A results

Experimental: Drug: HBI-3000, Stage B Dose Level 2 - Stage B Double-blind placebo controlled, Cohort 2 HBI-3000 Dose Level 2: Selected based on Stage A, and Stage B Cohort 1 results


Treatment: Drugs: HBI-3000
Small molecule, multi-ion channel blocker

Treatment: Drugs: Placebo
Normal saline
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by the incidence of adverse events (AEs)
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by changes in heart rate (HR)
Timepoint [2] 0 0
90 minutes
Primary outcome [3] 0 0
Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by change in blood pressure (BP)
Timepoint [3] 0 0
90 minutes
Primary outcome [4] 0 0
Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by ECG interval changes above a specific level
Timepoint [4] 0 0
24 hours
Primary outcome [5] 0 0
The efficacy of intravenously (IV) administered HBI-3000 as measured by the proportion of patients with AF of recent onset who convert to SR
Timepoint [5] 0 0
120 minutes
Secondary outcome [1] 0 0
Evaluate the time to conversion to SR from start of infusion
Timepoint [1] 0 0
24 hours
Secondary outcome [2] 0 0
Evaluate the proportion of patients with sustained AF or late conversion to SR
Timepoint [2] 0 0
12 hours, 24 hours and 7 days

Eligibility
Key inclusion criteria
- 18 to 80 years of age

- Sustained AF of > 2 hours and < 72 hours duration

- Eligible for cardioversion (electrical and pharmacologic)

- On adequate anticoagulant therapy or eligible for anticoagulation during treatment and
for at least 30 days duration after treatment if indicated by ACC/AHA/HRS or country
specific national or international guidelines for thromboembolic risk reduction
related to AF
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Atrial fibrillation < 2 hours or > 72 hours duration or with duration not reliably
established at the time of dosing

- Hemodynamic instability that may require emergency electrical cardioversion

- Atrial flutter

- Moderate to severe HF

- Clinical or ECG signs of acute cardiac ischemia or digitalis toxicity

- Known or suspected hyperthyroidism

- Cardiac surgery, stroke, TIA, acute MI/ PCI, unstable angina, or persistent angina at
rest within the previous 3 months

- Presence of LA thrombus by TEE or TTE

- Presence of concurrent myocarditis or endocarditis

- ECG abnormalities: Current QTcF > 480 msec; QRS interval > 120 msec and/or a complete
bundle branch block (BBB)l Delta wave or other pre-excitation pattern consistent with
WPW syndrome; Acute coronary ischemia patterns

- Use of medication that prolongs the QTc interval or history of: Long QT syndrome,
congenital or acquired; Torsades de Pointes (TdP); Brugada Syndrome; Ventricular
arrhythmia (not including infrequent isolated PVC)

- Concurrent treatment with Class I or III antiarrhythmic drugs, metformin or strong
CYP2D6 inhibitors (unless the medication is discontinued > 5 half-lives before
enrollment)

- Treatment with oral amiodarone in the previous 3 months or IV amiodarone administered
within 24 hours prior to planned Study Drug administration

- Use of vernakalant, or any experimental drug within 30 days or five half-lives
(whichever is longer) of Study Drug administration, or use of an invasive
investigational medical device within 2 months prior to Study Drug administration, or
current enrollment in another study with investigational agent or procedure

- Clinically significant laboratory abnormalities

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 2
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
1/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Mississippi
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Bosnia and Herzegovina
State/province [8] 0 0
Banja Luka
Country [9] 0 0
Bosnia and Herzegovina
State/province [9] 0 0
Bijeljina
Country [10] 0 0
Bosnia and Herzegovina
State/province [10] 0 0
Tuzla
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
New Zealand
State/province [12] 0 0
Hamilton
Country [13] 0 0
New Zealand
State/province [13] 0 0
Wellington
Country [14] 0 0
Serbia
State/province [14] 0 0
Bulevar Doktora
Country [15] 0 0
Serbia
State/province [15] 0 0
Belgrade
Country [16] 0 0
Serbia
State/province [16] 0 0
Užice

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
HUYABIO International, LLC.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This Phase 2 study is a two-stage, serial cohort dose escalation and expansion study of a
single 30-minute (IV) infusion of HBI-3000 for the conversion of patients with recent-onset
atrial fibrillation (AF).

Stage A is open label and all patients will receive HBI-3000. In each of three dose cohorts,
up to 10 patients will receive HBI-3000 by IV infusion (30 minutes). Three different dose
levels are planned to be administered serially, lowest to highest, with assessment of safety,
tolerability, and efficacy prior to proceeding to the next dose level group.

Following Stage A, the iDMC will recommend up to two doses of HBI-3000 to be further explored
in Stage B. Stage B is a serial, randomized, double-blind and placebo-controlled cohort of
two different doses of HBI-3000, with a dose decision after the first cohort. Stage B will be
powered to show a difference between HBI-3000 and placebo in conversion rate at each of the
two dose levels.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04680026
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04680026