Back to resultsThe PK/PD Study of A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects
Primary Purpose
Hypercholesteremia
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR-1209
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesteremia focused on measuring SHR-1209 Phase 1
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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
Sites / Locations
- FuWai Hospital , Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Arm Description
A single subcutaneous injection of SHR-1209 dose 1 versus placebo
A single subcutaneous injection of SHR-1209 dose 2 versus placebo
A single subcutaneous injection of SHR-1209 dose 3 versus placebo
A single subcutaneous injection of SHR-1209 dose 4 versus placebo
Outcomes
Primary Outcome Measures
Number of participants with adverse events
Secondary Outcome Measures
Assessment of PK parameter-time to maximum concentration (Tmax)
Assessment of PK parameter-maximum concentration (Cmax)
Assessment of PK parameter-area under curve (AUC)
Assessment of PD parameter-change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline
Assessment of PD parameter-change in Total Cholesterol (T-C) from baseline
Full Information
NCT ID
NCT03634436
First Posted
August 6, 2018
Last Updated
August 2, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03634436
Brief Title
The PK/PD Study of A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects
Official Title
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 30, 2018 (Actual)
Primary Completion Date
May 28, 2019 (Actual)
Study Completion Date
May 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesteremia
Keywords
SHR-1209 Phase 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
A single subcutaneous injection of SHR-1209 dose 1 versus placebo
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
A single subcutaneous injection of SHR-1209 dose 2 versus placebo
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
A single subcutaneous injection of SHR-1209 dose 3 versus placebo
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
A single subcutaneous injection of SHR-1209 dose 4 versus placebo
Intervention Type
Drug
Intervention Name(s)
SHR-1209
Intervention Description
Pharmaceutical form: lyophilized formulation
Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: lyophilized formulation
Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
Pre-dose to 150 days after dose administration
Secondary Outcome Measure Information:
Title
Assessment of PK parameter-time to maximum concentration (Tmax)
Time Frame
Pre-dose to 150 days after dose administration
Title
Assessment of PK parameter-maximum concentration (Cmax)
Time Frame
Pre-dose to 150 days after dose administration
Title
Assessment of PK parameter-area under curve (AUC)
Time Frame
Pre-dose to 150 days after dose administration
Title
Assessment of PD parameter-change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline
Time Frame
Pre-dose to 150 days after dose administration
Title
Assessment of PD parameter-change in Total Cholesterol (T-C) from baseline
Time Frame
Pre-dose to 150 days after dose administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
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
Facility Information:
Facility Name
FuWai Hospital , Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
The PK/PD Study of A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects
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