NCT03397641

A Phase 1 Study of HBI-3000

Completed Phase 1 Last updated 29 August 2018

What this trial tests

Phase 1 trial testing HBI-3000 in Atrial Fibrillation in 47 participants. Completed in 10 July 2018.

Timeline

17 October 2017

Primary endpoint
10 July 2018

10 July 2018

Quick facts

Lead sponsor	HUYABIO International, LLC.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	47
Start date	17 October 2017
Primary completion	10 July 2018
Estimated completion	10 July 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• HBI-3000 — full drug profile →
• Placebo

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

HUYABIO International, LLC. — full company profile →

Who can join

Adults 18 to 50, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1 randomised, double-blind, placebo-controlled, serial cohort, dose-escalation study in healthy adult volunteers. It is planned to enroll 5 cohorts (Cohorts A to E) of 8 subjects. Up to 2 additional cohorts (Cohorts F and G) may be enrolled as needed to establish the safety profile of HBI-3000 over a clinically relevant range of doses. Subjects will be randomly assigned to receive a single dose of HBI-3000 or matching placebo in a sequential escalating manner (Regimens A to E and optional Regimens F and G), with a minimum of 7 days and a maximum based on logistics of interim review between dose groups.

As a safety precaution, in each cohort a sentinel dosing group of n = 2 (1 active:1 placebo) will be dosed at least 24 h ahead of the main group. Safety and tolerability will be assessed by the principal investigator or medically-qualified designee before continuing with dosing the remaining subjects. The first 2 subjects will be allocated to active or placebo in a 1:1 ratio. The remaining 6 subjects will be allocated to active or placebo in a 5:1 ratio.

Doses of HBI-3000 may range from 20 mg to a level at which it is expected that the drug exposure will not exceed an AUC(0-t) of 20 μg.h/mL and Cmax of 20 μg/mL (based on the no-observed-adverse-effect levels \[NOAEL\] in both 14 day repeat dose toxicology species the rat and minipig) and the expected therapeutic dose range. Following administration to each cohort, there will be an interim data review during which the PK and safety data will be reviewed to determine the dose to be administered in the next cohort. Dose escalation for serial cohorts will progress unless safety concerns preclude further dose escalation. If the selected dose does not provide the required data, a previously tested dose may be used in a subsequent cohort. However, if the dose level met the dose escalation stopping criteria, that dose level must not be repeated. A previously untested intermediate dose may also be used in a subsequent cohort.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Electrocardiographic effects of HBI-3000 (sulcardine sulfate), a new drug for termination of atrial fibrillation.
   Mason JW, Romano SJ, Elliott GT, Mendzelevski B, et al · · 2026 · PMID 41737939 · DOI 10.1016/j.hroo.2025.11.019