Atrial FibrillationPhase 2NCT04680026
A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)
A Phase 2 study testing HBI-3000 in people with Atrial Fibrillation, run by HUYABIO International, LLC. at 14 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- HBI-3000
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 1 Jun 2021to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
United States4 sites
NCH Research Institute
Naples, Florida, 34102
Prairie Education & Research
Springfield, Illinois, 62701
North Mississippi Medical Center
Tupelo, Mississippi, 38801
CHRISTUS Trinity Mother Frances Hospital - Tyler
Tyler, Texas, 75701
Serbia4 sites
University Clinical Center of Serbia
Belgrade, 11000
Dedinje Institute for Cardiovascular Diseases
Belgrade, 11040
University Hospital Medical Center Bezanijska kosa
Belgrade, 11080
Niš University Clinical Center
Niš, Bulevar Doktora, 18108
Canada3 sites
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Centre hospitalier de L'Universite de Montral (CHUM)
Montreal, Quebec, H2X 0C1
Centre integre de sante et de services sociaux de Lanaudiere - Hopital Pierre-Le Gardeur
Terrebonne, Quebec, J6V 2H2
New Zealand2 sites
Waikato Hospital
Hamilton, 3240
Wellington Regional Hospital
Wellington, 6021
Bosnia and Herzegovina1 site
University Clinical Center of the Republic of Srpska
Banja Luka, 78000
About this study
Official 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
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.
Read the detailed description
This is a two-stage study in patients with AF of recent onset:
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). For each dosing cohort, sentinel dosing is planned. Each patient may enroll only once in the study, will be enrolled into only one dose cohort and receive only a single dose treatment. In Stage A, 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. The actual dose levels may be modified, and additional dose levels may be considered based on the observed results at each cohort.
Stage B is the randomized, double-blind and placebo-controlled part of the study. Study drug for Stage B patients is either HBI-3000 or placebo. Two cohorts will be enrolled sequentially, lowest dose level first, with safety, efficacy, and available PK results evaluated by the Sponsor and iDMC prior to enrolling patients in the next/higher dose cohort. The dose level for the second cohort may be adjusted following interim review of results in the first cohort. Patients will be randomized to receive a single IV infusion of HBI 3000 or placebo over 30 minutes. In each of the dose cohorts, sequentially enrolled patients will be randomized at 2:1 ratio so that 40 patients will receive HBI 3000 infusion and 20 patients will receive placebo infusion. Each patient may enroll only once in the study, will be enrolled into only one dose cohort and receive only a single dose treatment.
- Conditions
- Atrial Fibrillation
- Being tested
- HBI-3000, Placebo
- Keywords
- cardioversion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBI-3000Drug
Also called sulcardine sulfate
Small molecule, multi-ion channel blocker
PlaceboDrug
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Drug: HBI-3000, Stage A Dose Level 1 | Experimental | Stage A Open Label HBI-3000 Dose Level 1: 200 mg Receives: Drug: HBI-3000 |
| Drug: HBI-3000, Stage A Dose Level 2 | Experimental | Stage A Open Label HBI-3000 Dose Level 2: 350 mg planned Receives: Drug: HBI-3000 |
| Drug: HBI-3000, Stage A Dose Level 3 | Experimental | Stage A Open Label HBI-3000 Dose Level 2: 500 mg planned Receives: Drug: HBI-3000 |
| Drug: HBI-3000, Stage B Dose Level 1 | Experimental | Stage B Double-blind placebo controlled, Cohort 1 HBI-3000 Dose Level 1: Selected based on Stage A results Receives: Drug: HBI-3000; Drug: Placebo |
| Drug: HBI-3000, Stage B Dose Level 2 | Experimental | Stage B Double-blind placebo controlled, Cohort 2 HBI-3000 Dose Level 2: Selected based on Stage A, and Stage B Cohort 1 results Receives: Drug: HBI-3000; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
Measured: 30 days
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)
Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by change in heart rate (HR) from baseline (prior to Study Drug infusion) to study timepoints during and after Study Drug infusion, specifically:
HR < 40 bpm for 2 minutes or longer within 90 minutes of initiation of the infusion
HR increase > 25 percent before conversion to SR (based on one minute averages compared between the event and the first minute of stable telemetry)
HR > 120 bpm for one minute or longer after conversion to SR and within 90 minutes of initiation of the infusion
Measured: 90 minutes
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)
Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by changes in blood pressure (BP) from baseline (prior to Study Drug infusion) to study timepoints during and after Study Drug infusion, specifically: Systolic BP < 90 mmHg for > 1 minute during SR and within 90 minutes of initiation of the infusion
Measured: 90 minutes
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
Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by ECG interval changes from baseline (prior to Study Drug infusion) to 24 hour post-infusion, specifically:
QTcF: > 500 msec and > 60 msec above the 24-hour post-conversion level during SR
PR: > 50 percent above the 24-hour post-conversion level during SR
QRS: ≥ 33 percent above the 24-hour post-conversion level during SR
Measured: 24 hours
The efficacy of intravenously (IV) administered HBI-3000 as measured by the proportion of patients with AF of recent onset who convert to SR
Evaluate the efficacy of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset as measured by the proportion of patients with AF of recent onset who convert to SR (for a duration of at least one minute) within 120 minutes of the start of infusion
Measured: 120 minutes
Secondary outcomes (2)
Evaluate the time to conversion to SR from start of infusion
Efficacy as measured by the time from the start of infusion to the time of conversion to SR for a duration of at least one minute
Measured: 24 hours
Evaluate the proportion of patients with sustained AF or late conversion to SR
Efficacy as measured by the proportion of patients with sustained or late conversion of AF of recent onset to SR at 12 hours, 24 hours and 7 days after start of infusion
Measured: 12 hours, 24 hours and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Jun 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation: Stage A: non-randomized; Stage B: randomized, double-blind and placebo-controlled Intervention Model: Two-stage study Masking: None; Stage A (open label); Stage B: randomized, double-blind and placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HUYABIO International, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680026
- Sponsor's protocol ID
- HBI-3000-402
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2020
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04680026
- Acronym / sponsor ID
- HBI-3000-402
- Conditions
- Atrial Fibrillation
- Keywords
- cardioversion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- HUYABIO International, LLC.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a two-stage study in patients with AF of recent onset:
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). For each dosing cohort, sentinel dosing is planned. Each patient may enroll only once in the study, will be enrolled into only one dose cohort and receive only a single dose treatment. In Stage A, 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. The actual dose levels may be modified, and additional dose levels may be considered based on the observed results at each cohort.
Stage B is the randomized, double-blind and placebo-controlled part of the study. Study drug for Stage B patients is either HBI-3000 or placebo. Two cohorts will be enrolled sequentially, lowest dose level first, with safety, efficacy, and available PK results evaluated by the Sponsor and iDMC prior to enrolling patients in the next/higher dose cohort. The dose level for the second cohort may be adjusted following interim review of results in the first cohort. Patients will be randomized to receive a single IV infusion of HBI 3000 or placebo over 30 minutes. In each of the dose cohorts, sequentially enrolled patients will be randomized at 2:1 ratio so that 40 patients will receive HBI 3000 infusion and 20 patients will receive placebo infusion. Each patient may enroll only once in the study, will be enrolled into only one dose cohort and receive only a single dose treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Allocation: Stage A: non-randomized; Stage B: randomized, double-blind and placebo-controlled Intervention Model: Two-stage study Masking: None; Stage A (open label); Stage B: randomized, double-blind and placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Drug: HBI-3000, Stage A Dose Level 1 | Experimental | Drug: HBI-3000Stage A Open Label HBI-3000 Dose Level 1: 200 mg |
| Drug: HBI-3000, Stage A Dose Level 2 | Experimental | Drug: HBI-3000Stage A Open Label HBI-3000 Dose Level 2: 350 mg planned |
| Drug: HBI-3000, Stage A Dose Level 3 | Experimental | Drug: HBI-3000Stage A Open Label HBI-3000 Dose Level 2: 500 mg planned |
| Drug: HBI-3000, Stage B Dose Level 1 | Experimental | Drug: HBI-3000, Drug: PlaceboStage B Double-blind placebo controlled, Cohort 1 HBI-3000 Dose Level 1: Selected based on Stage A results |
| Drug: HBI-3000, Stage B Dose Level 2 | Experimental | Drug: HBI-3000, Drug: PlaceboStage B Double-blind placebo controlled, Cohort 2 HBI-3000 Dose Level 2: Selected based on Stage A, and Stage B Cohort 1 results |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBI-3000Also: sulcardine sulfateSmall molecule, multi-ion channel blocker | Drug | Drug: HBI-3000, Stage A Dose Level 1, Drug: HBI-3000, Stage A Dose Level 2, Drug: HBI-3000, Stage A Dose Level 3, Drug: HBI-3000, Stage B Dose Level 1, Drug: HBI-3000, Stage B Dose Level 2 |
| PlaceboNormal saline | Drug | Drug: HBI-3000, Stage B Dose Level 1, Drug: HBI-3000, Stage B Dose Level 2 |
Primary outcome
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)
Time frame: 30 days
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)
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)
Time frame: 90 minutes
Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by change in heart rate (HR) from baseline (prior to Study Drug infusion) to study timepoints during and after Study Drug infusion, specifically: HR < 40 bpm for 2 minutes or longer within 90 minutes of initiation of the infusion HR increase > 25 percent before conversion to SR (based on one minute averages compared between the event and the first minute of stable telemetry) HR > 120 bpm for one minute or longer after conversion to SR and within 90 minutes of initiation of the infusion
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)
Time frame: 90 minutes
Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by changes in blood pressure (BP) from baseline (prior to Study Drug infusion) to study timepoints during and after Study Drug infusion, specifically: Systolic BP < 90 mmHg for > 1 minute during SR and within 90 minutes of initiation of the infusion
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
Time frame: 24 hours
Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by ECG interval changes from baseline (prior to Study Drug infusion) to 24 hour post-infusion, specifically: QTcF: > 500 msec and > 60 msec above the 24-hour post-conversion level during SR PR: > 50 percent above the 24-hour post-conversion level during SR QRS: ≥ 33 percent above the 24-hour post-conversion level during SR
The efficacy of intravenously (IV) administered HBI-3000 as measured by the proportion of patients with AF of recent onset who convert to SR
Time frame: 120 minutes
Evaluate the efficacy of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset as measured by the proportion of patients with AF of recent onset who convert to SR (for a duration of at least one minute) within 120 minutes of the start of infusion
2 secondary outcomes
Evaluate the time to conversion to SR from start of infusion
Time frame: 24 hours
Evaluate the proportion of patients with sustained AF or late conversion to SR
Time frame: 12 hours, 24 hours and 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Major Gastrointestinal Bleeding (MGIB)
Not yet recruitingPhase 4
An Investigator-initiated, Prospective, Open-label, Multicenter Randomized Controlled Trial, Comparing the Efficacy of Sacubitril/Valsartan and Standard Treatment on Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients Without Hypertensive
Atrial Fibrillation (Persistent), Catheter Ablation
Recruiting
Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation
Atrial Fibrillation (AF)
Not yet recruiting
Paroxysmal Atrial Fibrillation Repeat Ablation Strategies With Durably Isolated Pulmonary Veins
Ablation Techniques, Atrial Fibrillation (Paroxysmal)
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HBI-3000 in people with Atrial Fibrillation, run by HUYABIO International, LLC. at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Serbia, Canada, New Zealand, Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025; AzTrials last refreshed its copy on 3 Nov 2026.