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

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Hypercholesteremia

Treatments: Drug: SHR-1209; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03634436

SHR-1209-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 4 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: SHR-1209

Drug: Placebo

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: SHR-1209

Drug: Placebo

Cohort 3

Experimental group

Description:

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

Treatment:

Drug: SHR-1209

Drug: Placebo

Cohort 4

Experimental group

Description:

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

Treatment:

Drug: SHR-1209

Drug: Placebo