Heart Failure
Conditions
Brief summary
This study was a randomized, double-blind, single-dose and multi-dose, placebo-controlled phase Ⅰ clinical trial. Six dose groups were planned for the SAD part of the study and four dose groups were planned for the MAD part. A total of 88 healthy subjects were included.
Interventions
DRUGSHR-6934 injection
SHR-6934 injection
DRUGSHR-6934 placebo
SHR-6934 placebo
Sponsors
Beijing Suncadia Pharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF); 2. Male or female aged 18-60; 3. Females must have a negative pregnancy test at the Screening Visit; 4. Body mass index (BMI) between 19 and 28 kg/m2; 5. Normal Electrocardiogram (ECG); 6. Men and women of childbearing potential must agree to take effective contraceptive methods.
Exclusion criteria
1. History of any clinically important disease or disorder; 2. History of drug or other allergies, or who, in the judgement of the investigator, may be allergic to the study drug or any component of the study drug; 3. Prior history of risk factors for Torsades de Pointes, such as unexplained syncope, definite long QT syndrome (including family history), heart failure, myocardial infarction, angina pectoris; 4. Systolic blood pressure (SBP)≥140 mmHg or \<90 mmHg, diastolic blood pressure (DBP) ≥90 mmHg or \<60 mmHg; 5. Patients with orthostatic hypotension; 6. Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of subjects with adverse events (AEs) | Baseline up to 113 days after the last dosing |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t) for SHR-6934 | Baseline up to 113 days after the last dosing |
| Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) for SHR-6934 | Baseline up to 113 days after the last dosing |
| Maximum plasma concentration (Cmax) for SHR-6934 | Baseline up to 113 days after the last dosing |
| Time to reach maximum plasma concentration (Tmax) for SHR-6934 | Baseline up to 113 days after the last dosing |
| Terminal half-life (t1/2) for SHR-6934 | Baseline up to 113 days after the last dosing |
| Apparent clearance (CL/F) of SHR-6934 for administration subcutaneously | Baseline up to 113 days after the last dosing |
| Apparent volume of distribution (V/F) of SHR-6934 for administration subcutaneously | Baseline up to 113 days after the last dosing |
| Proportion of anti-drug antibodies (ADA) positive subjects | Baseline up to 113 days after the last dosing |
| Baseline and placebo-adjusted QTcF after SHR-6934 | Baseline up to 15 days after dosing |
Countries
China
Outcome results
None listed