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CompletedNCT06837077Updated Jul 30, 2026

Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers

A Phase 1 interventional study of SHR-1209 single-site subcutaneous injection and SHR-1209 multiple-site subcutaneous injections in Hypercholesterolemia and Hyperlipidemia, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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. The study aims to compare the safety and pharmacokinetics data to assess feasibility of single-site and multiple-site injection for administration.

02

Conditions studied

  • Hypercholesterolemia and Hyperlipidemia
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 49 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Understanding the research procedures and methods, being able to complete the research in accordance with the procedure requirements, and sign the informed consent;
  2. The age on the date of signing the informed consent must be ≥18 years old and ≤55 years old;
  3. 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;
  4. 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.

Exclusion criteria

Exclusion Criteria:

  1. Serious infection within 3 months before screening;
  2. History of food or drug allergy or atopic allergic disease (asthma, urticaria);
  3. Positive blood pregnancy test;
  4. Have a history of drug abuse;
  5. Women who are pregnant or breastfeeding;
  6. Subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    Treatment group A

    Drug: SHR-1209 single-site subcutaneous injection · Drug: SHR-1209 multiple-site subcutaneous injections

  • Experimental
    Treatment group B

    Drug: SHR-1209 single-site subcutaneous injection · Drug: SHR-1209 multiple-site subcutaneous injections

Interventions

  • DrugSHR-1209 single-site subcutaneous injection

    SHR-1209 single-site subcutaneous injection.

  • DrugSHR-1209 multiple-site subcutaneous injections

    SHR-1209 multiple-site subcutaneous injections.

06

What researchers measure

Primary outcomes

  1. 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.

  2. 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.

  3. Area under the curve (AUC0-56).

    Time frame: After injection in day 1 up to day 56.

  4. Peak time (Tmax) of SHR-1209.

    Time frame: After injection in day 1 up to day 56.

  5. Peak concentration (Cmax) of SHR-1209.

    Time frame: After injection in day 1 up to day 56.

Secondary outcomes

  1. Subjects' preferred method of SHR-1209 administration between the tested injection regimens.

    Time frame: Day 68.

  2. Incidence and severity of adverse events (AEs).

    Time frame: From Day 1 to Day 169.

  3. Incidence and severity of serious adverse events (SAEs).

    Time frame: From Day 1 to Day 169.

07

Study locations

1 site
  • The First Affiliated Hospital of USTC
    Hefei, Anhui 230000, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06837077
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Feb 20, 2025
Start date
Mar 14, 2025
Primary completion
Nov 1, 2025
Completion
Nov 1, 2025
Last update
Jul 30, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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