Hypercholesteremia
Conditions
Keywords
SHR-1209 Phase 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.
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.
Interventions
DRUGSHR-1209
Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous
DRUGPlacebo
Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | Pre-dose to 150 days after dose administration |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed