Safety and Tolerability of SHR-1918 in Healthy Subjects

Study Overview
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Brief Summary
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The primary objective of this study is to assess the safety and tolerability of SHR-1918 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-1918 injection in healthy subjects.

Official Title
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A Phase 1, Randomized, Double Blind, Dose-escalation, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injection of SHR-1918 Injection in Healthy Subjects

Conditions
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Hyperlipemia

Intervention / Treatment
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* Drug: SHR-1918
* Drug: SHR-1918 placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 and ≤65 on the date of signing the informed consent, males or females; 1.7 mmol/L≤TG≤5.6 mmol/L，2.6 mmol/L≤LDL-C<4.9 mmol/L; Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent. Exclusion Criteria: - 1.History of disease or treatment for: Known allergic reaction to experimental drugs or severe allergic reaction to other antibody drugs; Malignncy; Combined cardiovascular, hepatic, renal, gastrointestinal, neuropsychiatric, hematological, or metabolic diseases; History of any drug use prior to screening or within 2 weeks prior to baseline 2.Any one of the following tests at screening : Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma-glutamyl transferase (GGT) exceeding 2 times ULN, or total bilirubin exceeding 1.5 times ULN Creatine kinase (CK) exceeding 3 times the upper limit of normal (ULN) 3.General: History of drug or substance abuse; Average of 5 or more cigarettes per day during the 4 weeks prior to screening; History of blood donation within 3 months prior to screening, or severe blood loss (≥400 mL blood loss), or received a blood transfusion within 4 weeks; Vaccination within 2 weeks prior to screening or planned during the course of the trial 4.The Investigator determines that the subjects have poor compliance or have any factors that may prevent them from participating in the study, including, but not limited to, the study placing the subjects at unacceptable risk or possibly interfering with the study results.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: SHR-1918 injection compared with placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAD, SHR-1918<br>Up to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 injection | Drug: SHR-1918<br>* Ascending dose<br>|
| Placebo Comparator: SAD, SHR-1918 placebo<br>Up to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 placebo injection | Drug: SHR-1918 placebo<br>* Ascending dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the number of subjects with adverse events (AEs) |  | up to day 190 | 
| To assess the number of subjects with serious adverse events (SAEs) |  | up to day 190 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess AUC0-t |  | up to day 190 | 
| To assess AUC0-∞ |  | up to day 190 | 
| To assess Tmax |  | up to day 190 | 
| To assess Cmax |  | up to day 190 | 
| To assess t1/2 |  | up to day 190 | 
| To assess CL/F |  | up to day 190 | 
| To assess 、V/F. |  | up to day 190 | 
| To assess LDL-C |  | up to day 190 | 
| To assess TC |  | up to day 190 | 
| To assess HDL-C |  | up to day 190 | 
| To assess TG |  | up to day 190 | 
| To assess ApoB |  | up to day 190 | 
| To assess ApoA1 |  | up to day 190 | 
| To assess Lp(a) |  | up to day 190 | 
| To assess VLDL-C. |  | up to day 190 | 
| To assess ADA(or/and Nab). |  | up to day 190 |