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CompletedNCT05370950Updated Jan 12, 2023

Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers

A Phase 1 interventional study of SHR-1209 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 2023-01-12.

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

Phase
Phase 1
Study type
Interventional
Enrollment
159
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

In order to meet the preferences and needs of different patients for injection sites and improve the medication compliance of patients, it is planned to compare the bioavailability, pharmacokinetics, pharmacodynamic and safety data to assess feasibility of multiple injection sites 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 159 is above 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 ≥18.5 kg/m2 and \<30.0 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 2 weeks before screening to 6 months after the 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. History of the following diseases or treatments:

    Diseases that affect drug absorption, distribution, metabolism, and excretion determined by the investigator; Serious infection within 3 months before screening; History of drug allergy or atopic allergic disease (asthma, urticaria).

  2. Any one of the following tests at Screening period or Baseline period:

    Human immunodeficiency virus antibody (HIV-Ab), syphilis serological examination, hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab) positive; Positive blood pregnancy test.

  3. General situation:

    Have a history of drug use or drug abuse; Women who are pregnant or breastfeeding.

  4. 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
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
159 participants (actual)

Study arms

  • Experimental
    Treatment group A

    Drug: SHR-1209

  • Experimental
    Treatment group B

    Drug: SHR-1209

  • Experimental
    Treatment group C

    Drug: SHR-1209

Interventions

  • DrugSHR-1209

    SHR-1209，single subcutaneous injection of 450mg

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: area under the curve (AUC0-t)

    Time frame: Days 1-113

  2. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: area under the curve (AUC0-∞)

    Time frame: Days 1-113

  3. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: peak concentration (Coax)

    Time frame: Days 1-113

Secondary outcomes

  1. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: time to peak (Tmax)

    Time frame: Days 1-113

  2. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: terminal elimination half-life (t1/2)

    Time frame: Days 1-113

  3. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: apparent volume of distribution (Vz/F)

    Time frame: Days 1-113

  4. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: apparent clearance (CL/F)

    Time frame: Days 1-113

  5. Incidence and severity of adverse events (AE), serious adverse events (SAE), etc.

    Time frame: Days 1-113

07

Study locations

1 site
  • The Second Affiliated Hospital of Anhui Medical University
    Hefei, Anhui 230601, 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 Jan 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05370950
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
May 12, 2022
Start date
May 25, 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Jan 12, 2023

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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