NCT05286970已完成1 期
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of Single Dose Subcutaneous Administration of AK115 in Healthy Subjects
Akeso1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年3月18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
- 42
- 试验地点
- 1
- 主要终点
- Incidence and severity classification of adverse events
研究概览
简要总结
This trial is a randomized, double-blind, placebo-controlled dose escalation phase I trial following single dose subcutaneous administration of AK115 injection.
It aims to evaluate the safety, pharmacokinetic characteristics, pharmacodynamic effect and immunogenicity of single dose of AK115 injection in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subjects fully understand the purpose, content, process and possible adverse reactions of the trial, voluntarily participate in the trial, and sign the informed consent before any test procedure;
- •Healthy male and female subjects aged 18-55 years (including 18 and 55 years);
- •Male weight ≥ 50.0kg, female weight ≥ 45.0kg; Body mass index (BMI) = body weight (kg) / height 2 (M2), in the range of 19.0 ~ 26.0kg/m2 (including the critical value);
- •The blood pregnancy test results of female subjects of chidbearing potential during the screening period were negative. During the whole trial period and within 84 days after receiving the inveatigational drug, the subjects and their partners voluntarily take effective contraceptive measures specified in the protocol. Female subjects without childbearing potential need to meet the standards specified in the protocol,
- •The subjects can communicate well with the researchers, understand and comply with the requirements of this trial protocol.
排除标准
- •Allergic to AK115 component and any monoclonal antibody, or have a history of allergies of 3 or more kinds food or drugs ;
- •There are accompanying diseases , or previous serious and chronic diseases and those who have not been cured;
- •The results of physical examination, laboratory examination or ECG examination in the screening period are judged by the researcher to be abnormal and clinically significant;
- •Have a history of transplantation of important organs;
- •Abnormal liver and kidney functions and blood routine, refer to the protocol
- •Hepatitis B surface antigen, hepatitis C antibody, HIV antigen antibody, Treponema pallidum antibody positive;
- •History of alcohol abuse or Drug abusers within 12 months before screening or those with positive urine drug screening results during screening;
- •Blood donation or massive blood loss (> 400ml) or Smoking more than 5 cigarettes per day within 3 months before check-in;
- •Female subjects are in pregnancy or lactation;
- •Use of medications including over-the-counter medication within 14 days before the investigational drug;
- •Participated in the clinical trial of any trial drug within 3 months before the investigational drug or still within 5 half lives of other trial drugs (whichever is longer);
- •Subjects who received monoclonal antibodies or other biological agents within 3 months before investigational drug;
- •Subjects who had received systemic corticosteroids 12 months before screening;
- •Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment
研究组 & 干预措施
10mg AK115or placebo SC
Experimental
single-dose
干预措施: Placebo (Drug)
30mg AK115or placebo SC
Experimental
single-dose
干预措施: AK115 (Drug)
30mg AK115or placebo SC
Experimental
single-dose
干预措施: Placebo (Drug)
60mg AK115or placebo SC
Experimental
single-dose
干预措施: AK115 (Drug)
60mg AK115or placebo SC
Experimental
single-dose
干预措施: Placebo (Drug)
10mg AK115or placebo SC
Experimental
single-dose
干预措施: AK115 (Drug)
0.5mg AK115 SC
Experimental
single-dose
干预措施: AK115 (Drug)
1mg AK115or placebo SC
Experimental
single-dose
干预措施: AK115 (Drug)
1mg AK115or placebo SC
Experimental
single-dose
干预措施: Placebo (Drug)
3mg AK115or placebo SC
Experimental
single-dose
干预措施: AK115 (Drug)
3mg AK115or placebo SC
Experimental
single-dose
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity classification of adverse events
时间窗: 0-12week
Incidence and severity classification of adverse events
次要结局
- Pharmacokinetic parameters of AK115 in healthy subjects(0-12week)
- Immunogenicity characteristics: the number and percentage of anti AK115 antibody (ADA)(0-12week)
- Immunogenicity characteristics: time to ADA positive(0-12week)
- Immunogenicity characteristics: the number and percentage of neutralizing antibody (NAB) positive subjects(0-12week)
- Changes in serum total nerve growth factor (NGF) levels from baseline.(0-12 week)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
1 期
Clinical Trial to Assess Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus PyogenesRheumatic FeverNCT03998592Butantan Institute
招募中
1 期
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetic of TQB3702 Tablets in Healthy Adult SubjectsSystemic Lupus ErythematosusNCT06448273Chia Tai Tianqing Pharmaceutical Group Co., Ltd.40
已完成
1 期
A Clinical Study to Evaluate MW33 InjectionCovid19NCT04533048Mabwell (Shanghai) Bioscience Co., Ltd.42
已完成
1 期
Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic ParticipantsBirch Pollen AllergyNCT06037148Desentum Oy30
已完成
1 期
ICVAX as a HIV Therapeutic DNA VaccineHuman Immunodeficiency VirusHuman Immunodeficiency Virus I InfectionNCT06253533Immuno Cure Holding (HK) Limited45