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

NCT03634436 | Completed Phase 1

• 1 other identifier: SHR-1209-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesteremia

Keywords

SHR-1209 Phase 1

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  Pre-dose to 150 days after dose administration

Secondary Outcomes (5)

• Assessment of PK parameter-time to maximum concentration (Tmax)

  Pre-dose to 150 days after dose administration

• Assessment of PK parameter-maximum concentration (Cmax)

  Pre-dose to 150 days after dose administration

• Assessment of PK parameter-area under curve (AUC)

  Pre-dose to 150 days after dose administration

• Assessment of PD parameter-change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline

  Pre-dose to 150 days after dose administration

• Assessment of PD parameter-change in Total Cholesterol (T-C) from baseline

  Pre-dose to 150 days after dose administration

Study Arms (4)

Cohort 1

EXPERIMENTAL

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

Drug: SHR-1209; Drug: Placebo

Cohort 2

EXPERIMENTAL

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

Drug: SHR-1209; Drug: Placebo

Cohort 3

EXPERIMENTAL

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

Drug: SHR-1209; Drug: Placebo

Cohort 4

EXPERIMENTAL

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

Drug: SHR-1209; Drug: Placebo

Interventions

SHR-1209 DRUG

Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Placebo DRUG

Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18 and ≤45 years old;
• 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;
• Serum LDL-C concentration≥2.0mmol/L and \< 4.1mmol/L;
• Fasting triglycerides \< 2.3 mmol/L;
• The comprehensive physical examination is eligible or slightly abnormal but the researchers determine no clinical implication.
• Signed informed consent.

You may not qualify if:

• Subjects determined by the researchers have diseases that affect drug absorption, distribution, metabolism and excretion or low compliance;
• 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;
• Serum creatinine exceeded the upper limit of normal value (ULN) during screening;
• 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;
• Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
• Subjects with previous malignant tumor diseases;
• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

FuWai Hospital , Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 40587053 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 16, 2018
• Study Start: August 30, 2018
• Primary Completion: May 28, 2019
• Study Completion: May 28, 2019
• Last Updated: August 3, 2022

Record last verified: 2019-09

Locations

CN (1)