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

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ClinicalTrials.gov Identifier: NCT03634436
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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.


Condition or disease Intervention/treatment Phase
Hypercholesteremia Drug: SHR-1209 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : July 31, 2019

Arm Intervention/treatment
Experimental: Cohort 1
A single subcutaneous injection of SHR-1209 dose 1 versus placebo
Drug: SHR-1209

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous


Drug: Placebo

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous


Experimental: Cohort 2
A single subcutaneous injection of SHR-1209 dose 2 versus placebo
Drug: SHR-1209

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous


Drug: Placebo

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous


Experimental: Cohort 3
A single subcutaneous injection of SHR-1209 dose 3 versus placebo
Drug: SHR-1209

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous


Drug: Placebo

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous


Experimental: Cohort 4
A single subcutaneous injection of SHR-1209 dose 4 versus placebo
Drug: SHR-1209

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous


Drug: Placebo

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous





Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Pre-dose to 150 days after dose administration ]

Secondary Outcome Measures :
  1. Assessment of PK parameter-time to maximum concentration (Tmax) [ Time Frame: Pre-dose to 150 days after dose administration ]
  2. Assessment of PK parameter-maximum concentration (Cmax) [ Time Frame: Pre-dose to 150 days after dose administration ]
  3. Assessment of PK parameter-area under curve (AUC) [ Time Frame: Pre-dose to 150 days after dose administration ]
  4. Assessment of PD parameter-change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline [ Time Frame: Pre-dose to 150 days after dose administration ]
  5. Assessment of PD parameter-change in Total Cholesterol (T-C) from baseline [ Time Frame: Pre-dose to 150 days after dose administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634436


Contacts
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Contact: Jing Xia +86-18910446100 xiajing@hrglobe.cn
Contact: Robert Zhu +86-13380043088 zhubo@hrglobe.cn

Locations
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China, Beijing
FuWai Hospital , Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China
Contact: Li xin Jiang         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03634436     History of Changes
Other Study ID Numbers: SHR-1209-101
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
SHR-1209 Phase 1
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases