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

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolemia and Hyperlipidemia

Treatments: Drug: SHR-1209

Study type: Interventional

Funder types: Industry

Identifiers

NCT05370950

SHR-1209-104

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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159 participants in 3 patient groups

Treatment group A

Experimental group

Treatment:

Drug: SHR-1209

Treatment group B

Experimental group

Treatment:

Drug: SHR-1209

Treatment group C

Experimental group

Treatment:

Drug: SHR-1209