The PK/PD Study of A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects

NCT ID: NCT03634436

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-30
• Study Completion Date: 2019-05-28

Brief Summary

This is a Single Center, Randomized, Double-blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics with A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects.

The primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous SHR-1209 in healthy subjects. Secondary objectives are to determine the pharmacokinetics (PK) and pharmacodynamics(PD) profile of SHR-1209 in healthy subjects including assessment of immunogenicity.

Detailed Description

32 adult healthy subjects with 4 dose groups will be enrolled in the study, including two subjects in the lowest dose group, all of whom received the SHR-1209 without placebo control. The other three groups have 10 subjects in each group, 8 administered SHR-1209 and 2 administered placebo. The primary endpoint is the Safety and Tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc.

Conditions

Hypercholesteremia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1

A single subcutaneous injection of SHR-1209 dose 1 versus placebo

Group Type: EXPERIMENTAL

SHR-1209

Intervention Type: DRUG

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous

Placebo

Intervention Type: DRUG

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous

Cohort 2

A single subcutaneous injection of SHR-1209 dose 2 versus placebo

Group Type: EXPERIMENTAL

SHR-1209

Intervention Type: DRUG

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous

Placebo

Intervention Type: DRUG

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous

Cohort 3

A single subcutaneous injection of SHR-1209 dose 3 versus placebo

Group Type: EXPERIMENTAL

SHR-1209

Intervention Type: DRUG

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous

Placebo

Intervention Type: DRUG

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous

Cohort 4

A single subcutaneous injection of SHR-1209 dose 4 versus placebo

Group Type: EXPERIMENTAL

SHR-1209

Intervention Type: DRUG

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous

Placebo

Intervention Type: DRUG

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous

Interventions

SHR-1209

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous

Intervention Type: DRUG

Placebo

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 and ≤45 years old;

2. The body mass index (BMI) should be 19 or greater and < 28kg/m2, the male weigh ≥50.0kg and <90.0kg, and the female weigh ≥45.0kg and <90.0kg;

3. Serum LDL-C concentration≥2.0mmol/L and < 4.1mmol/L;

4. Fasting triglycerides < 2.3 mmol/L;

5. The comprehensive physical examination is eligible or slightly abnormal but the researchers determine no clinical implication.

6. Signed informed consent.

Exclusion Criteria

1. Subjects determined by the researchers have diseases that affect drug absorption, distribution, metabolism and excretion or low compliance;

2. A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar experimental drugs;

3. Serum creatinine exceeded the upper limit of normal value (ULN) during screening;

4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT), more than 2 x ULN, or total bilirubin more than 1.5 x ULN during screening;

5. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;

6. Subjects with previous malignant tumor diseases;

7. 3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs (test drug half-life more than 3 months) before screening. etc

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

FuWai Hospital , Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

References

Shu C, Wang Y, Feng S, Yang S, Shen K. Population Pharmacokinetics and Pharmacodynamics Modeling for the Use of Recaticimab in Healthy Volunteers and Patients with Hypercholesterolemia. Clin Pharmacokinet. 2025 Sep;64(9):1341-1355. doi: 10.1007/s40262-025-01512-5. Epub 2025 Jun 30.

Reference Type: DERIVED

PMID: 40587053 (View on PubMed)

Other Identifiers

SHR-1209-101

Identifier Type: -

Identifier Source: org_study_id