Hypercholesterolemia and HyperlipidemiaPhase 1NCT06837077
Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers
A Phase 1 study testing SHR-1209 single-site subcutaneous injection and SHR-1209 multiple-site subcutaneous injections in people with Hypercholesterolemia and Hyperlipidemia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia and Hyperlipidemia
- What is being tested?
- SHR-1209 single-site subcutaneous injection and SHR-1209 multiple-site subcutaneous injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2025to 1 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Serious infection within 3 months before screening;
- History of food or drug allergy or atopic allergic disease (asthma, urticaria);
- Positive blood pregnancy test;
- Have a history of drug abuse;
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Hypercholesterolemia and Hyperlipidemia
- Being tested
- SHR-1209 single-site subcutaneous injection, SHR-1209 multiple-site subcutaneous injections
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1209 single-site subcutaneous injectionDrug
SHR-1209 single-site subcutaneous injection.
SHR-1209 multiple-site subcutaneous injectionsDrug
SHR-1209 multiple-site subcutaneous injections.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: SHR-1209 single-site subcutaneous injection; Drug: SHR-1209 multiple-site subcutaneous injections |
| Treatment group B | Experimental | Not described Receives: Drug: SHR-1209 single-site subcutaneous injection; Drug: SHR-1209 multiple-site subcutaneous injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) was used to evaluate the injection site pain of single-site subcutaneous injection of SHR-1209.
Measured: After injection in day 1 and day 57.
Visual Analog Scale (VAS) was used to evaluate the injection site pain of multiple-site subcutaneous injections of SHR-1209.
Measured: After injections in day 1 and day 57.
Area under the curve (AUC0-56).
Measured: After injection in day 1 up to day 56.
Peak time (Tmax) of SHR-1209.
Measured: After injection in day 1 up to day 56.
Peak concentration (Cmax) of SHR-1209.
Measured: After injection in day 1 up to day 56.
Secondary outcomes (3)
Subjects' preferred method of SHR-1209 administration between the tested injection regimens.
Measured: Day 68.
Incidence and severity of adverse events (AEs).
Measured: From Day 1 to Day 169.
Incidence and severity of serious adverse events (SAEs).
Measured: From Day 1 to Day 169.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start14 Mar 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercholesterolemia and HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837077
- Sponsor's protocol ID
- SHR-1209-105
- Status last verified
- Jul 2026
- First submitted
- 7 Jan 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06837077
- Acronym / sponsor ID
- SHR-1209-105
- Conditions
- Hypercholesterolemia and Hyperlipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR-1209 single-site subcutaneous injection, Drug: SHR-1209 multiple-site subcutaneous injections |
| Treatment group B | Experimental | Drug: SHR-1209 single-site subcutaneous injection, Drug: SHR-1209 multiple-site subcutaneous injections |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Serious infection within 3 months before screening;
- History of food or drug allergy or atopic allergic disease (asthma, urticaria);
- Positive blood pregnancy test;
- Have a history of drug abuse;
- Women who are pregnant or breastfeeding;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1209 single-site subcutaneous injectionSHR-1209 single-site subcutaneous injection. | Drug | Treatment group A, Treatment group B |
| SHR-1209 multiple-site subcutaneous injectionsSHR-1209 multiple-site subcutaneous injections. | Drug | Treatment group A, Treatment group B |
Primary outcome
Visual Analog Scale (VAS) was used to evaluate the injection site pain of single-site subcutaneous injection of SHR-1209.
Time frame: After injection in day 1 and day 57.
Visual Analog Scale (VAS) was used to evaluate the injection site pain of multiple-site subcutaneous injections of SHR-1209.
Time frame: After injections in day 1 and day 57.
Area under the curve (AUC0-56).
Time frame: After injection in day 1 up to day 56.
Peak time (Tmax) of SHR-1209.
Time frame: After injection in day 1 up to day 56.
Peak concentration (Cmax) of SHR-1209.
Time frame: After injection in day 1 up to day 56.
3 secondary outcomes
Subjects' preferred method of SHR-1209 administration between the tested injection regimens.
Time frame: Day 68.
Incidence and severity of adverse events (AEs).
Time frame: From Day 1 to Day 169.
Incidence and severity of serious adverse events (SAEs).
Time frame: From Day 1 to Day 169.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-1209 single-site subcutaneous injection and SHR-1209 multiple-site subcutaneous injections in people with Hypercholesterolemia and Hyperlipidemia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) was used to evaluate the injection site pain of single-site subcutaneous injection of SHR-1209. (time frame: After injection in day 1 and day 57.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.