Status:
COMPLETED
A Phase 1 Study of HBI-3000
Lead Sponsor:
HUYABIO International, LLC.
Collaborating Sponsors:
Quotient Clinical
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- Healthy males or non-pregnant, non-lactating healthy females
- Age 18 to 50 years
- Body mass index of 18.0 to 30.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Minimum body weight of 60 kg
- Must be willing and able to communicate and participate in the whole study
- Normal hepatic function as evidenced by AST and alanine aminotransferase (ALT) \<1.5 × ULN and alkaline phosphatase (ALP) and total bilirubin within the normal range
- Haemodynamically stable with systolic BP 90 to 150 mm Hg, diastolic BP \<95 mmHg and resting HR ≥45 and ≤100 bpm
- Forced expiratory volume in 1 s (FEV1) \>80% predicted value and FEV1/ forced vital capacity (FVC) ratio \>0.7
- Must provide written informed consent
- Must agree to use an adequate method of contraception
Exclusion
- Subjects who have received any IMP in a clinical research study within the previous 3 months
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subjects who have previously been enrolled in this study.
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- Females of childbearing potential who are pregnant or lactating (all female subjects must have a negative pregnancy test). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone \[FSH\] concentration ≥40 IU/L)
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
- Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis as judged by the investigator, including:
- Serum K \<3.5 mmol/L
- Serum magnesium concentration of \<0.7 mmol/L
- Serum phosphate \<2.5 or \>4.5 mg/dL
- Positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of \<80 mL/min using the Cockcroft-Gault equation
- Evidence of any clinically relevant acute or chronic medical illness, including renal, hepatic, haematological, endocrine, pulmonary (including asthma), oncologic, neurologic or gastrointestinal disease, or psychiatric disorder, as judged by the investigator
- History or presence of clinically significant cardiovascular disease, including coronary artery disease, myocardial infarction or ischemia, congestive heart failure, valvular disease, congenital heart disease or prior cardiac surgery
- History or presence of cardiac arrhythmia or conduction abnormalities, including long-QT syndrome, TdeP, Wolff-Parkinson-White syndrome or bradycardia (\<45 bpm)
- QTcF interval \>450 or QRS \>120 msec
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol and HRT/hormonal contraception) or herbal remedies in the 14 days before IMP administration (see Section 11.4). Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
- Failure to satisfy the investigator of fitness to participate for any other reason
Key Trial Info
Start Date :
October 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2018
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03397641
Start Date
October 17 2017
End Date
July 10 2018
Last Update
August 29 2018
Active Locations (1)
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1
Quotient Clinical
Nottingham, United Kingdom, NG11 6JS