KCT0007911尚未招募未知
An Open-label, Randomized, Single- and Multiple-dose, Phase 1 Clinical Trial to Evaluate the Pharmacokinetics of Iron and Safety/Tolerability after the Oral Administration of KP-01 in Korean Adult with Iron Deficiency (with or without anaemia)
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 55(Year)（—）
- 性别
- All
入选标准
- •1)Subjects who are adult volunteers aged 18 ~ 55 at the time of the screening test
- •2)Subjects with Body Mass Index (BMI) of 18.0 kg/m2 ~ 28.0 kg/m2 at the time of the screening test
- •- Body Mass Index, kg/m2 = weight(kg)/{height(m)}2
- •3)Subjects with ferritin < 30 µg/L, or ferritin < 50 µg/L and transferrin saturation (TSAT) < 20% at the time of the screening test
- •4)Subjects with hemoglobin (Hb) = 8.5 g/dL measured at the time of the screening test, regardless of anemia symptoms
- •5)Subjects who have full understanding of this clinical trial after sufficient explanation, have voluntarily decided to participate, and submitted their written consent for compliance with the precautions
排除标准
- •1)Subjects who have diseases that can induce impaired absorption of the investigational drug (ex. short bowel syndrome, malabsorption syndrome, and celiac disease)
- •2)Subjects who have received gastrointestinal resection that can influence the absorption of the investigational drug (ex. gastrectomy, gastric bypass surgery, and enterectomy)
- •3)Subjects who have a history of hypersensitivity reaction to the ingredients of the investigational drug, same drug class, or drugs containing iron, or history of clinically significant hypersensitivity reaction
- •4)Subjects who have hereditary disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •5)Subjects who have diseases that require restriction of iron replacement drugs (ex. hemochromatosis, chronic hemolytic anemia, thalassemia, and sideroblastic anemia)
- •6)Subjects with ongoing infective disease
- •7)Subjects who have inflammatory bowel disease that is uncontrolled, leading to discomfort in daily living, or severe inflammatory bowel disease (CDAI score = 220 in the case of Crohn’s disease, and Mayo score = 6 in the case of ulcerative colitis)
- •8)Subjects with the following results in the screening tests, including additional tests
- •?Blood level of AST (SGOT), ALT (SGPT) > upper limit of normal range × 2.0
- •?Blood level of Creatinine > upper limit of normal range × 1.5
- •9)Subjects with positive results for serologic tests (hepatitis B, hepatitis C, Human Immunodeficiency Virus (HIV), and syphilis)
- •10)Subjects who have a history of drug abuse, or who showed positive results for drug abuse in the urine screening test
- •11)Subjects who were administered with iron replacement drugs in the form of injection within 28 days prior to the first planned administration of the investigational drug
- •12)Subjects who were administered with oral iron replacement drugs within 7 days prior to the first planned administration of the investigational drug
- •13)Subjects who were administered with erythropoiesis stimulating agents within 28 days prior to the first planned administration of the investigational drug
- •14)Subjects who were administered with the investigational drug in a separate clinical trial (including bioequivalence trials) within 6 months prior to the first planned administration of the investigational drug
- •15)Subjects who were administered with the investigational drug in a separate clinical trial (including bioequivalence trials) within 6 months prior to the first planned administration of the investigational drug
- •16)Subjects who have diseases that are accompanied by profuse bleeding (excluding menstrual bleeding in female subjects)
- •17)Female subjects who are pregnant, breastfeeding, or have plans of pregnancy
- •18)Subjects who are not able to take the iron-restricted diet required for the duration of the clinical trial
- •19)Subjects (or their spouses or partners) who cannot, or will not use medically permitted contraceptive method for the whole duration of the clinical trial and for at least 4 weeks following the final administration of the investigational drug, and subjects who meet at least one of the following conditions
- •-Subjects who do not agree to refrain from sperm donation for the above duration
- •-Subjects who do not agree to refrain from ovum donation for the above duration
- •-Subjects who were confirmed to be positive in a pregnancy test
- •-Fertile subjects (who experienced menarche, have not received successful contraceptiv
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