Heart Failure
Conditions
Brief summary
This is a clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic and immunogenicity of single subcutaneous injection of SHR-4658 in healthy volunteers and volunteers with elevated blood pressure.
Interventions
DRUGSHR-4658 Injection.
SHR-4658 injection.
DRUGSHR-4658 Placebo Injection
SHR-4658 placebo injection.
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 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Able and willing to provide a written informed consent. 2. Blood pressure as defined in the protocol. 3. Male or female，aged 18 to 55 years (inclusive). 4. Meet the weight standard.
Exclusion criteria
1. Known history or current clinically significant disease. 2. Protocol-defined risk factors for disease. 3. Participated in clinical trials of other drugs or medical devices. 4. Pregnant or nursing women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) | Approximately 16 weeks. |
Secondary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve from time 0 to infinity (AUC0-inf) | Approximately 16 weeks. |
| Maximum observed concentration (Cmax) | Approximately 16 weeks. |
| Time to maximum observed concentration (Tmax) | Approximately 16 weeks. |
| Area under the concentration-time curve from time 0 to the last time point (AUC0-last) | Approximately 16 weeks. |
| Apparent volume of distribution (Vd/F) | Approximately 16 weeks. |
| Terminal elimination half-life (t1/2) | Approximately 16 weeks. |
| Apparent clearance (CL/F) | Approximately 16 weeks. |
Countries
China
Contacts
Primary ContactMiao Guo
Backup ContactShuai Jiang
Outcome results
None listed