NCT06229548已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2053 in Subjects With Normal or Elevated Low-Density Lipoprotein Cholesterol
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- The Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of SYH2053 when administered subcutaneously to subjects with normal and elevated LDL-C.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must give informed consent before the trial, fully understand the content, procedures and possible adverse reactions, and voluntarily sign a written informed consent.
- •Sex: male or female subjects.
- •Age of 18 - 60 years (inclusive).
- •BMI: 18.6-28.5 kg/m^2 (inclusive), with a minimum weight of 50 kg (inclusive) for male and 45 kg (inclusive) for female.
- •During screening and baseline, LDL-C ≥100 mg/dL (2.6 mmol/L) and < 190 mg/dL (4.9 mmol/L); TG ≤ 400 mg/dL (4.5 mmol/L); TC < 278 mg/dL (7.2 mmol/L) in serum under fasting state;
- •Subjects have no history of chronic or serious diseases or family history of early-onset coronary heart disease, including cardiovascular, liver, kidney, blood and lymphatic, endocrine, immune, psychiatric, neurological, and gastrointestinal systems, and are generally in good health.
- •The subjects can communicate well with the investigators and complete the trial according to the protocol.
排除标准
- •Allergic constitution or known history of allergy to the components of the study drug or similar drugs.
- •Antibody drugs targeting PCSK9 have been used within 6 months prior to screening, oligonucleotides targeting PCSK9 have been used within 12 months prior to screening.
- •There are currently medical disorders of clinical significance, including but not limited to, circulatory, hematological or hematopoietic diseases, respiratory, endocrine, urinary, digestive, neurological or psychiatric disorders, infections, tumors, severe trauma, or any other diseases that the investigator considers to be excluded or likely to interfere with the interpretation of the findings.
- •Those who underwent major surgery within 6 months prior to initial administration, or who planned to undergo surgery during the study.
- •Clinically significant abnormalities in vital signs, physical examination, electrocardiogram and laboratory examination.
- •The estimated glomerular filtration rate (eGFR) during screening was < 90 mL/min/1.73 m^2 (calculated by simplified MDRD formula).
- •During screening, any item of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), γ-glutamyltransferase (GGT), alkaline phosphatase (ALP) > 1.5×ULN (retest once within 1 week allowed).
- •During screening or baseline, subjects with prolonged QT/QTc interval (QTcF > 450 ms in male, > 470 ms in female).
- •Subjects with non-negative test for any of HBsAg, HCV antibodies, syphilis antibodies, and HIV antibodies.
- •Blood loss or blood donation of more than 200 mL within 3 months prior to administration (except for female menstrual period), and/or platelet donation within 2 weeks prior to administration.
- •Use of any drug, supplement, vitamin or dietary supplement known to affect lipid metabolism within 28 days prior to administration; use of any drug for therapeutic purposes (except topical drugs with local effects) within 14 days prior to administration or within the 7 half-lives of the drug (whichever is longer).
- •A history of drug abuse, and/or drug use within 3 months prior to screening, and/or habitual use of any psychotropic drug, including Chinese herbs.
- •Positive urine drug screening.
研究组 & 干预措施
SYH2053 SAD experimental group
Experimental
Subjects in SAD experimental groups will receive a single subcutaneous injection of SYH2053 on Day 1.
干预措施: SYH2053 (Drug)
Placebo SAD group
Placebo Comparator
Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
The Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
时间窗: Pre-dose and multiple timepoints no less than 57 days
The investigator will make an assessment of intensity for each AE and SAE reported during the study according to CTCAE V5.0
次要结局
- The serum LDL-C level after dosing SYH2053(Pre-dose and multiple timepoints no less than 57 days)
- The serum PCSK9 level after dosing SYH2053(Pre-dose and multiple timepoints no less than 57 days)
- PK parameters (Cmax)(Pre-dose and multiple timepoints up to 4 days)
- PK parameters (Tmax)(Pre-dose and multiple timepoints up to 4 days)
- PK parameters (AUC)(Pre-dose and multiple timepoints up to 4 days)
- PK parameters (T1/2)(Pre-dose and multiple timepoints up to 4 days)
- Immunogenicity of SYH2053(Pre-dose and multiple timepoints up to 57 days)
- The serum TC level after dosing SYH2053(Pre-dose and multiple timepoints no less than 57 days)
- The serum TG level after dosing SYH2053(Pre-dose and multiple timepoints no less than 57 days)
- The serum HDL-C level after dosing SYH2053(Pre-dose and multiple timepoints no less than 57 days)
- The serum Lp(a) level after dosing SYH2053(Pre-dose and multiple timepoints no less than 57 days)
- The serum VLDL-C level after dosing SYH2053(Pre-dose and multiple timepoints no less than 57 days)
- The serum non-HDL-C level after dosing SYH2053(Pre-dose and multiple timepoints no less than 57 days)
- The serum ApoA1 level after dosing SYH2053(Pre-dose and multiple timepoints no less than 57 days)
- The serum ApoB level after dosing SYH2053(Pre-dose and multiple timepoints no less than 57 days)
- The serum hsCRP level after dosing SYH2053(Pre-dose and multiple timepoints no less than 57 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety and Tolerability of BSI-045B in Healthy Adult Subjects and Patients With Atopic DermatitisAtopic DermatitisNCT05114889Biosion, Inc.54
已完成
1 期
A Phase 1 AVB-S6-500 Safety and Tolerability StudyHealthy VolunteerNCT03401528Aravive, Inc.43
Unknown
1 期
Single Ascending Dose Study to Investigate the Safety and Pharmacokinetics of XC101-D13H in Healthy Adult SubjectsMigraineNCT04104399Xoc Pharmaceuticals32
Unknown
1 期
Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult SubjectsParkinson's DiseaseNCT04043338Xoc Pharmaceuticals56
已完成
1 期
A Single Ascending Dose Study of BTZ043Tuberculosis, PulmonaryBacterial InfectionsLung DiseasesMycobacterium InfectionsTuberculosisNCT03590600Michael Hoelscher30