A Dose Block-randomized, Double-blind, Placebo Controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Oral Dose of HL237 in Healthy Male Subject
试验速览
- 阶段
- 1 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration [Cmax]
研究概览
简要总结
HL237 is a new autoimmune therapeutic agent for rheumatoid arthritis, including the basic structure of biguanide in metformin, an existing diabetes drug.
The immune modulating activity of HL237 was demonstrated in animal model. HL237 is a STAT3 inhibitor and STAT3 is well known for an important regulator inhibiting Th17 cells and activating Treg cells.
Therefore, when STAT3 activity is inhibited, it is expected to be able to treat autoimmune diseases such as rheumatoid arthritis.
This is the first repeated administration clinical trial performed for the development of HL237 and is intended to evaluate the safety, tolerability and pharmacokinetics of each dose group.
详细描述
Doses are increased sequentially from low-capacity groups, and within six weeks after the last dose of the last subject in the ongoing dose phase, if available pharmacokinetic data are judged acceptable under review by investigators, sponsor and safety review committees, then proceed to the next dose stage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A healthy adult male aged 20 years or older and 45 years old at the time of the screening test
- •Those who weigh more than 55kg but weigh less than ± 20% of ideal body weight
- •Proper contraception during the clinical trial period
- •After hearing the detailed explanation of the clinical trial, those who decide to participate voluntarily and write agreement
排除标准
- •Clinically significant, a person with a history of neurological, psychiatric, malignant, cardiovascular, respiratory, kidney, endocrine, hematologic, digestive or central disease
- •a person with a history of gastrointestinal disorders that may affect the absorption of pharmaceuticals for clinical trials (Crohn's disease, ulcers, etc.) or gastrointestinal surgery (except for simple cecal surgery or hernia surgery)
- •a person with a history of hypersensitivity or clinically significant hypersensitivity to the clinical trial drug or additives
- •a person judged to be inappropriate for the subject by health screening (history of disease, physical examination, vital signs, electrocardiogram, laboratory test, etc.)
研究组 & 干预措施
HL237 400mg
HL237 100mg 2 tablets twice a day
干预措施: Placebo Oral Tablet (Drug)
HL237 200mg
HL237 100mg 1 tablet twice a day
干预措施: HL237 (Drug)
HL237 200mg
HL237 100mg 1 tablet twice a day
干预措施: Placebo Oral Tablet (Drug)
HL237 400mg
HL237 100mg 2 tablets twice a day
干预措施: HL237 (Drug)
HL237 800mg
HL237 400mg 1 tablet twice a day
干预措施: HL237 (Drug)
HL237 800mg
HL237 400mg 1 tablet twice a day
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Maximum Plasma Concentration [Cmax]
时间窗: 14days after administration
maximum serum concentration after the drug has been administrated
Area Under the Curve [AUC]
时间窗: 14days after administration
AUC after the drug has been administrated
Half life [t1/2]
时间窗: 14days after administration
Half life after the drug has been administrated
次要结局
- Number of participants with treatment-related adverse events(14days after administration)