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NCT05370950 | Completed | Hypercholesterolemia and Hyperlipidemia

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

Jiangsu H鞥R UI medicine co., Ltd.

Brief 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.

Condition or disease

Hypercholesterolemia and Hyperlipidemia

Intervention/treatment

SHR-1209

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 159 participants
Masking : None (Open Label)
Primary Purpose : Basic Science
Official Title : A Single-center, Randomized, Parallel, Open-label Study to Compare the Bioavailability, Pharmacodynamics, and Safety of SHR-1209 Given as Single Subcutaneous Injection at Different Sites in Healthy Volunteers
Actual Study Start Date : May 25, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022
Arm Intervention/treatment

Experimental: Treatment group A

Drug: SHR-1209

Experimental: Treatment group B

Drug: SHR-1209

Experimental: Treatment group C

Drug: SHR-1209
Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • 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 ≥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;
  • 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
  • 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).
    • 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.
      • General situation
        • Have a history of drug use or 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.
Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Anhui

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230601