Rheumatoid Arthritis (RA)
Conditions
Brief summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single-dose subcutaneous injection of SHR-3045 in healthy subjects.
Interventions
SHR-3045 injection.
SHR-3045 placebo injection.
Sponsors
Guangdong Hengrui Pharmaceutical 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. Subjects with ability to understand the trial procedures and possible adverse events, voluntary participation in the trial. 2. Subjects who can provide written informed consent. 3. Males or females aged 18-55 years (both inclusive). 4. Males with body weight ≥ 50 kg, or females with body weight ≥ 45 kg, body mass index (BMI) 19-28 kg/m2 (both inclusive). 5. No clinically significant abnormalities in the medical history, general physical examinations, vital signs and laboratory tests.
Exclusion criteria
1. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening. 2. Known or suspected history of drug abuse. 3. Addiction to tobacco and alcohol. 4. Individuals who are unable to adhere to the dietary requirements of this trial during the study period. 5. Judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) | From screening period up to Day 113. |
Secondary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve from time 0 to the last time point after SHR-3045 administration (AUC0-last). | Post-dose at Day 1 to Day 113. |
| Area under the concentration-time curve from time 0 to infinity after SHR-3045 administration (AUC0-inf). | Post-dose at Day 1 to Day 113. |
| Maximum observed concentration of SHR-3045 (Cmax). | Post-dose at Day 1 to Day 113. |
| Time to maximum observed concentration of SHR-3045 (Tmax). | Post-dose at Day 1 to Day 113. |
| Apparent clearance of SHR-3045 (CL/F). | Post-dose at Day 1 to Day 113. |
| Apparent volume of distribution of SHR-3045 (Vz/F). | Post-dose at Day 1 to Day 113. |
| Terminal elimination half-life of SHR-3045 (t1/2). | Post-dose at Day 1 to Day 113. |
Countries
China
Outcome results
None listed