NCT07200596CompletedPhase 1
The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of SHR-3045 in Healthy Subjects
The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Dose Subcutaneous Injection of SHR-3045 in Healthy Subjects-A Randomized, Double-Blind, Dose-Escalating, Placebo-Controlled Phase I Study
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 23 Sept 2025
- Start date
- 8 Oct 2025
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07200596
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 16
- From 8 Oct 2025 to the primary completion date, 31 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening.
Other illness
- Known or suspected history of drug abuse.
- Judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.
Other
- Addiction to tobacco and alcohol.
- Individuals who are unable to adhere to the dietary requirements of this trial during the study period.
Who the study is looking for
- Subjects with ability to understand the trial procedures and possible adverse events, voluntary participation in the trial.
- Subjects who can provide written informed consent.
- Males or females aged 18-55 years (both inclusive).
- Males with body weight ≥ 50 kg, or females with body weight ≥ 45 kg, body mass index (BMI) 19-28 kg/m2 (both inclusive).
- No clinically significant abnormalities in the medical history, general physical examinations, vital signs and laboratory tests.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Frist Affiliated Hospital of USTC (Anhui Provincial Hospital) Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.