NCT06837077CompletedPhase 1
Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers
A Single-center, Randomized, Crossover, Open-label Phase I Study to Compare the Safety and Pharmacokinetics of SHR-1209 Given as Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
In order to improve the medication convenience and compliance of patients and facilitates in the long-term control of disease condition, it is planned to reduced the number of injections to one per administration. The study aims to compare the safety and pharmacokinetics data to assess feasibility of single-site and multiple-site injection for administration.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 49 (actual)
- First submitted
- 7 Jan 2025
- Start date
- 14 Mar 2025
- Primary completion date
- 1 Nov 2025
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06837077
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 49
- From 14 Mar 2025 to the primary completion date, 1 Nov 2025
- 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
- Serious infection within 3 months before screening;
Other illness
- History of food or drug allergy or atopic allergic disease (asthma, urticaria);
- Have a history of drug abuse;
Other
- Positive blood pregnancy test;
- Women who are pregnant or breastfeeding;
- Subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study.
Who the study is looking for
- Understanding the research procedures and methods, being able to complete the research in accordance with the procedure requirements, and sign the informed consent;
- The age on the date of signing the informed consent must be ≥18 years old and ≤55 years old;
- Body mass index (BMI) at screening period must be ≥19.0 kg/m2 and \<28.0 kg/m2, weight of male must≥ 50.0 kg and \<90.0 kg, and female≥ 45.0 kg and \<90.0 kg;
- The subjects and their female partners are willing to have no reproductive plan from signing the informed consent to 16 weeks after the last administration of the study drug, and voluntarily take effective contraceptive measures and do not plan to donate sperm or ovum.
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 First Affiliated Hospital of USTC Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.