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

Hypercholesteremia Clinical Trial

Official title:

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634436
• Other study ID #: SHR-1209-101
• Status: Completed
• Phase: Phase 1
• Start date: August 30, 2018
• Est. completion date: May 28, 2019

Study information

• Verified date: September 2019
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 28, 2019
• Est. primary completion date: May 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesteremia
• Hypercholesterolemia

Intervention

Drug:
• SHR-1209
Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous
• Placebo
Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous

Locations

Country	Name	City	State
China	FuWai Hospital , Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		Pre-dose to 150 days after dose administration
Secondary	Assessment of PK parameter-time to maximum concentration (Tmax)		Pre-dose to 150 days after dose administration
Secondary	Assessment of PK parameter-maximum concentration (Cmax)		Pre-dose to 150 days after dose administration
Secondary	Assessment of PK parameter-area under curve (AUC)		Pre-dose to 150 days after dose administration
Secondary	Assessment of PD parameter-change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline		Pre-dose to 150 days after dose administration
Secondary	Assessment of PD parameter-change in Total Cholesterol (T-C) from baseline		Pre-dose to 150 days after dose administration