Hyperlipidemia
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single-dose of JS401 in healthy volunteers with normal or mildly elevated triglycerides.
Interventions
DRUGJS401
Single dose of JS401 by subcutaneous (sc) injections
DRUGPlacebo
Calculated volume to match active treatment
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female subjects aged 18\ 60 (inclusive) at the time of signing the ICF, with no less than 1/3 of either gender; 2. Fasting TG≥1.1mmol/L (100 mg/dL) and ≤ 5.0mmol/L (450mg/dL) at screening; (3) Fasting LDL-C at screening\> 1.8 mmol/L (70 mg/dL).
Exclusion criteria
1. Have a medical history or clinical evidence that the subject has obvious concomitant diseases (including but not limited to: cardiovascular, respiratory, digestive, urinary, neurological, blood, immunological, endocrine and metabolic, infection, etc.), or any clinically significant abnormalities found in physical examination, laboratory examination, and ECG examination, which are judged by the investigator to not meet the standards of clinical health or are not suitable for participating in clinical trials; 2. Acute or chronic infection requiring hospitalization or undergoing systemic parenteral therapy (antiviral/bacterial/fungal/parasitic, etc.) within 60 days prior to randomization; 3. Positive for syphilis antibodies, or positive for human immunodeficiency virus (HIV) antibodies, or positive for hepatitis C virus (HCV) antibodies, or positive for hepatitis B virus surface antigen (HBsAg) at screening; 4. History of substance abuse within 12 months prior to screening, or positive urine drug screening at screening; 5. History of alcohol dependence within 6 months prior to screening, or positive breath test for alcohol at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to 112 days post-dose | Number of Participants with Adverse Events (AEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) | Up to 48 hours post-dose | Time to Maximum Plasma Concentration of JS401 |
| Terminal Elimination Half-Life (t1/2) | Up to 48 hours post-dose | Terminal Elimination Half-Life (t1/2) of JS401 |
| Area Under the Plasma Concentration Versus Time Curve (AUC) | Up to 48 hours post-dose | Area Under the Plasma Concentration Versus Time Curve of JS401 |
| Angiopoietin-like 3 (ANGPTL3) | Up to 112 days post-dose | Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline |
| Triglycerides | Up to 112 days post-dose | Reduction in Fasting Serum LDL-C from Pre-Dose Baseline |
| immunogenic characteristics ADA of JS401 | Up to 112 days post-dose | The number and percentage of subjects who were positive for anti-JS401 anti-drug antibody (ADA) after administration of JS401 injection were counted, and the titer of ADA-positive samples was analyzed. |
| Low-density lipoprotein cholesterol (LDL-C) | Up to 112 days post-dose | Reduction in Fasting Serum LDL-C from Pre-Dose Baseline |
| Peak Plasma Concentration (Cmax) | Up to 48 hours post-dose | Peak Plasma Concentration of JS401 |
| Very low-density lipoprotein cholesterol (VLDL-C) | Up to 112 days post-dose | Reduction in Fasting Serum VLDL-C from Pre-Dose Baseline |
| High-density lipoprotein cholesterol (HDL-C) | Up to 112 days post-dose | Reduction in Fasting SerumHDL-C from Pre-Dose Baseline |
| Lipoprotein (a) (Lp(a)) | Up to 112 days post-dose | Reduction in Fasting Lp(a) from Pre-Dose Baseline |
| Apolipoprotein B (ApoB) | Up to 112 days post-dose | Reduction in Fasting ApoB from Pre-Dose Baseline |
| Apolipoprotein A1 (ApoA1) | Up to 112 days post-dose | Reduction in Fasting ApoA1 from Pre-Dose Baseline |
| Q-T interval | Up to 112 days post-dose | Change in QTc from baseline |
| Non-high-density lipoprotein cholesterol (non-HDL-C) | Up to 112 days post-dose | Reduction in Fasting Serum non-HDL-C from Pre-Dose Baseline |
Countries
China
Contacts
Primary ContactFugui Wang
Outcome results
None listed