NCT05398510已完成1 期
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous/Subcutaneous Injection of SHR-2010 in Healthy Subjects: a Randomized, Double-blind, Dose-increasing, Placebo-controlled Phase I Clinical Trial
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2022年6月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Safety and tolerability: Incidence of subjects with adverse events (AEs)
研究概览
简要总结
The study is being conducted to Evaluate the Safety, Tolerability and Pharmacokinetics pharmacodynamics of SHR-2010 by intravenously/subcutaneously in Healthy Subject.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to provide a written informed consent.
- •Male or non-pregnant, non-lactating female ages 18 to 55 years old.
- •Weight ≥ 45 kg, and body mass index (BMI) must range from 18 to 28 kg/m2 .
- •Healthy subjects as determined by absence of clinically significant abnormalities on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests performed at screening or baseline period.
- •Subjects must be willing to use a highly effective method of contraception as deemed appropriate by the investigator throughout the study and for at least 3 months after the last study drug administration.
排除标准
- •Evidence or history of serious cardiovascular, hepatic, renal, gastrointestinal, psychiatric, neurological, haematological, or metabolic diseases within 5 years.
- •Subjects with tuberculosis diagnosed by Interferon Gamma Release Assays (IGRA) or chest X-ray.
- •Subjects had any surgery within the past 6 months before screening or planned to undergo surgery during the study period.
- •Estimated Glomerular Filtration Rate（eGFR）<90 mL/min/1.73m
- •Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening.
- •Systolic blood pressure (SBP) > 140 mm Hg or < 90 mm Hg, or diastolic blood pressure (DBP) > 90 mm Hg or < 60 mm Hg and has been considered clinically significant.
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma-glutamyl transferase (GGT) ≥2.0 x ULN, or total bilirubin ≥1.5 x ULN.
- •Clinically significant abnormal 12-lead ECG at screening (male with QTcF > 450 ms or female with QTcF > 470 ms).
- •Female subjects who had unprotected sexual behaviour within 14 days before screening.
- •Positive for alcohol breath test at screening or baseline period.
- •Positive urinary drug test at screening or baseline period.
- •Blood collection is difficult or cannot tolerate venipuncture blood collection.
- •Allergic to any ingredient or component in the study drug.
- •Subjects who have taken any prescription drugs, over-the-counter drugs, or Chinese herbal medicine within 14 days prior to using the study drug.
- •Subjects who smoked more than 5 cigarettes daily in the 1 month before screening.
- •History of regular alcohol consumption exceeding 3 units/day for women or 5 units/day for men, more than twice per week (1 unit = 150 ml of beer or 50 ml of wine or 17 ml of alcoholic spirits) within 3 months before screening.
- •Participated in any other clinical trials of any drug or medical device within 3 months before screening.
- •Donated blood or blood products or had substantial loss of blood (more than 400 mL) within 1 month before screening, or received any blood or blood products within 2 months prior to screening.
- •Subjects who received live (attenuated) vaccine within 1 month prior to screening or consider getting a vaccination during the study.
- •The employee of investigator or study centre, with direct involvement in the proposed study.
- •The investigators determined that other conditions were inappropriate for participation in this clinical trial.
研究组 & 干预措施
Treatment for intravenously/subcutaneously
Experimental
Treatment for intravenously: 6 dose groups； Treatment for subcutaneously: 3 dose groups.
干预措施: SHR-2010 injection (Drug)
Placebo for intravenously/subcutaneously
Placebo Comparator
Treatment for intravenously: 6 dose groups； Treatment for subcutaneously: 3 dose groups.
干预措施: SHR-2010 injection placebo (Drug)
结局指标
主要结局
Safety and tolerability: Incidence of subjects with adverse events (AEs)
时间窗: Baseline up to Day 85
Incidence of AEs, including any abnormal findings in vital signs, and/or physical examination and/or clinical laboratory assessments and/or 12-lead ECG evaluation and/or IGRA.
次要结局
- Pharmacokinetics (PK) parameter: AUC0-t for SHR-2010(Baseline up to Day 85)
- Pharmacokinetics (PK) parameter: t1/2 for SHR-2010(Baseline up to Day 85)
- Pharmacokinetics (PK) parameter: AUC0-∞ for SHR-2010(Baseline up to Day 85)
- Pharmacokinetics (PK) parameter: CL of SHR-2010 for administration intravenously(Baseline up to Day 85)
- Pharmacokinetics (PK) parameter: Cmax for SHR-2010(Baseline up to Day 85)
- Pharmacokinetics (PK) parameter: V of SHR-2010 for administration intravenously(Baseline up to Day 85)
- Pharmacokinetics (PK) parameter: V/F of SHR-2010 for administration subcutaneously(Baseline up to Day 85)
- Pharmacokinetics (PK) parameter: Tmax for SHR-2010(Baseline up to Day 85)
- Pharmacokinetics (PK) parameter: CL/F of SHR-2010 for administration subcutaneously(Baseline up to Day 85)
- Pharmacodynamics (PD): C4b level in the serum(Baseline up to Day 85)
- Immunogenicity: Proportion of anti-drug antibodies (ADA) positive subjects(Baseline up to Day 85)
- Pharmacokinetics (PK) parameter: Bioavailability (F) of SHR-2010(Baseline up to Day 85)
研究者
研究点 (1)
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