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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-25

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia and Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center, random, parallel, open-label

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment group A

Group Type EXPERIMENTAL

SHR-1209

Intervention Type DRUG

SHR-1209，single subcutaneous injection of 450mg

Treatment group B

Group Type EXPERIMENTAL

SHR-1209

Intervention Type DRUG

SHR-1209，single subcutaneous injection of 450mg

Treatment group C

Group Type EXPERIMENTAL

SHR-1209

Intervention Type DRUG

SHR-1209，single subcutaneous injection of 450mg

Interventions

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SHR-1209

SHR-1209，single subcutaneous injection of 450mg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes