Phase 1 Dose-Escalation Study of IV Administered HBI-3000 (QCL117964)
Research type
Research Study
Full title
A Phase I, Randomised, Double-Blind, Placebo-Controlled, Serial Cohort, Dose-Escalation Study of Intravenously Administered HBI-3000
IRAS ID
229286
Contact name
Laurie Rosenberg
Contact email
Sponsor organisation
HUYA Bioscience International, LLC
Eudract number
2017-002077-19
Duration of Study in the UK
0 years, 5 months, 10 days
Research summary
The Sponsor is developing a new formulation of a test medicine designed to treat atrial fibrillation (AF) (an irregular and often rapid heart rate that can increase the risk of stroke, heart failure and other heart-related complications). The test medicine (HBI-3000) is being developed as an alternative treatment option for AF.\n\nThe purpose of the study is to assess the safety and tolerability of the test medicine after it is given intravenously (directly into the vein in the arm), as well as the impact of the body on the drug (pharmacokinetics), in comparison with the placebo in healthy adult subjects.\n\nThe study will enroll up to 7 cohorts (A-G) of 8 male and female subjects, with cohorts F and G being optional cohorts that may be enrolled as needed for further safety information. Subjects will take part in 1 cohort. In each cohort subjects will be randomly assigned to receive a single intravenous (IV) dose of HBI-3000 or matching placebo on 1 occasion.\n\nDoses given per cohort may be given in a sequential escalating manner, doses may range from 20 mg to a level where the drug exposure will not exceed an AUC(0-t) (the body’s exposure to the study drug) of 20 µg.h/mL and Cmax (maximum observed concentration in the blood) of 20 µg/mL. A minimum of 7 days is planned between dose groups. \n\nFor each cohort, subjects will be admitted to the clinic on the evening of Day -2. Subjects will remain resident in the clinical unit until the morning of Day 3. Subjects will return to the clinic on the morning of Day 4 (72 hours after dosing) to provide blood samples. Subjects will also attend a follow-up visit approximately 6-8 days after they were dosed to ensure their continued wellbeing.\n
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0496
Date of REC Opinion
28 Sep 2017
REC opinion
Favourable Opinion