Healthy Volunteers
Conditions
Brief summary
To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of HRS-9231 injection in a single dose in healthy subjects
Interventions
DRUGHRS-9231
HRS-9231 was administered intravenously;
DRUGPlacebo
Placebo was administered intravenously.
Sponsors
Shanghai Shengdi Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age between 18 to 45 years. 2. Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive). 3. Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).
Exclusion criteria
1. Patients with contraindications for magnetic resonance imaging (MRI) examinations. 2. During the screening period, those whose 12-lead electrocardiogram examination is judged by clinical doctors as abnormal and of clinical significance will be selected. 3. Those with a history of drug abuse, drug use, or positive results in drug abuse screening. 4. Unable to tolerate venipunctures or have a history of fainting needles and blood. 5. People with various urinary disorders (such as frequent urination, difficulty in urination, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, serious adverse events | From ICF signing date to Day10 |
Secondary
| Measure | Time frame |
|---|---|
| Cmax：maximum concentration measured. Blood samples were taken to assess HRS-9231 concentration | From baseline (1 hour before injection) to 12 hours post-injection |
| t1/2 = terminal elimination half-life of the compound | From baseline (1 hour before injection) to 12 hours post-injection |
| Cl = total clearance | From baseline (1 hour before injection) to 12 hours post-injection |
Countries
China
Outcome results
None listed