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To Determine the Maximum Tolerated Dose (MTD) of HK-001 in Healthy Volunteers 1상 56 무작위 배정 단일 투여
A Phase I Study to Determine the Maximum Tolerated Dose (MTD) of HK-001 and to Evaluate Its Pharmacokinetic Profile in Healthy Volunteers
- EFBORAZ20141120
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
위약 대조군Placebo control Eligible subjects will receive either different dosages of HK-001 or placebo in a 3:1 ratio in 1 of the 7 dose cohorts consisting of 8 subjects each. | 위약 대조 In order to evaluate the safety and tolerability of HK-001 more accurately, a drug-free placebo control is planned to be utilized for the same administration route in this proposed trial. The placebo control that is identical in appearance, smell, weight, and excipients will be supplied by Everfront Biotech Inc. |
실험적50 mg, BID Eligible subjects will receive either different dosages of HK-001 or placebo in a 3:1 ratio in 1 of the 7 dose cohorts consisting of 8 subjects each. | HK-001 HK-001 is synthesized by PharmaCore Biotech Co., Ltd. Synthetic (Z)-BP with high purity will be used in this proposed study. |
실험적100 mg, BID Eligible subjects will receive either different dosages of HK-001 or placebo in a 3:1 ratio in 1 of the 7 dose cohorts consisting of 8 subjects each. | HK-001 HK-001 is synthesized by PharmaCore Biotech Co., Ltd. Synthetic (Z)-BP with high purity will be used in this proposed study. |
실험적150 mg, BID Eligible subjects will receive either different dosages of HK-001 or placebo in a 3:1 ratio in 1 of the 7 dose cohorts consisting of 8 subjects each. | HK-001 HK-001 is synthesized by PharmaCore Biotech Co., Ltd. Synthetic (Z)-BP with high purity will be used in this proposed study. |
실험적225 mg, BID Eligible subjects will receive either different dosages of HK-001 or placebo in a 3:1 ratio in 1 of the 7 dose cohorts consisting of 8 subjects each. | HK-001 HK-001 is synthesized by PharmaCore Biotech Co., Ltd. Synthetic (Z)-BP with high purity will be used in this proposed study. |
실험적300 mg, BID Eligible subjects will receive either different dosages of HK-001 or placebo in a 3:1 ratio in 1 of the 7 dose cohorts consisting of 8 subjects each. | HK-001 HK-001 is synthesized by PharmaCore Biotech Co., Ltd. Synthetic (Z)-BP with high purity will be used in this proposed study. |
실험적400 mg, BID Eligible subjects will receive either different dosages of HK-001 or placebo in a 3:1 ratio in 1 of the 7 dose cohorts consisting of 8 subjects each. | HK-001 HK-001 is synthesized by PharmaCore Biotech Co., Ltd. Synthetic (Z)-BP with high purity will be used in this proposed study. |
실험적525 mg, BID Eligible subjects will receive either different dosages of HK-001 or placebo in a 3:1 ratio in 1 of the 7 dose cohorts consisting of 8 subjects each. | HK-001 HK-001 is synthesized by PharmaCore Biotech Co., Ltd. Synthetic (Z)-BP with high purity will be used in this proposed study. |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Maximum Tolerated Dose (MTD) | The MTD will be determined by study definition as the highest dose level without significant safety and tolerability concern. | 48 days |
Dose Limiting Toxicities (DLT) | In this study, the DLTs are defined as below:
1. Any Grade ≥2 AE found during study period that is considered at least possibly drug related as judged by the investigator. The NCI-CTCAE 4.03 will be used to grade serum chemistry, hematology, and other abnormalities in the current study.
2. Any drug-related (including probably or possibly drug-related) serious adverse event (SAE) found during study period. | 48 days |
Subject's age is no less than 20 years old.
Subjects whose body mass index (BMI) at screening is within a range of ≥18.5 kg/m2 and <25.0 kg/m2.
BMI = Body Weight (kg) / \[Height (m)\]2 And body weight is not less than 50 kg and 45 kg for males and females, respectively.
Subject's medical history shows no contraindication to the test medications \[hypersensitivity to (Z)-BP or any component of test and reference products\].
Subjects who are judged to be in good health by the investigator based upon the results of physical examinations (PEs) and chest X-ray (within 60 days prior to the first study dose), and all items of routine laboratory tests, including serum biochemistry, hematology and urinalysis, are within normal range as judged by the site. Assessment items of blood biochemistry include electrolytes (sodium, potassium, chloride, calcium, phosphorus), albumin, total cholesterol, total bilirubin, ALP, SGOT, SGPT, GGT, BUN, PT, APPT, serum creatinine, triglyceride, glucose, amylase, lipase, ACTH, aldosterone, cortisol, T3, free T4, TSH, and uric acid. Assessment items of hematology tests include red blood cell (RBC), white blood cell (WBC) and platelet count; differential WBC count including neutrophils, lymphocytes, monocytes, eosinophils, and basophils; hemoglobin, and hematocrit. Assessment items of urinalysis include appearance, gravity, pH, erythrocyte, leukocyte, epithelial cells, glucose, protein, ketones, and nitrite
Female subjects show negative pregnancy test results within 30 days prior to the first study dose.
Subjects did not take any of the following medications in the specified durations:
- Any medication (except contraceptives) within 14 days prior to the first dose of the study
- Any enzyme inducer or inhibitor within 30 days prior to the first dose of the study
Subjects understood and have signed the written informed consent form.
Subjects with any properly diagnosed disease within 30 days prior to the first dose of the study
Subjects with a clinically significant hematological, endocrinal, cardiovascular, hepatic, renal, gastrointestinal, and/or pulmonary disorders; subjects with any predisposing condition that might interfere with the absorption, distribution, metabolism and excretion of drugs; subjects who have had any previous gastrointestinal surgery, except appendectomy if performed >90 days prior to the first dose of the study
Subjects who have received any known hepatic or renal clearance-altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazine, clarithromycin, trolearndomycin, ketoconazole, miconazolem fluconazole, itraconazole) for a period of up to 30 days prior to the first dose of the study
Subjects had participated in investigational drug trials and took any investigational drugs within 60 days prior to the first study dose.
Subjects had blood donation for more than 250 mL within 60 days prior to the first dose of the study.
Subjects had a history of drug abuse or alcohol abuse according to DSM IV criteria.
Subjects who are smokers or have smoking history
Subjects who cannot stop caffeine-intakes for 48 hours prior to the first study dose and during the entire study period.
Subjects who are pregnant or lactating
For enrollment of female subjects with child-bearing potential, the subject must be practicing sexual abstinence or be using and willing to continue to use a medically acceptable form of birth control for at least 1 month prior to screening (that period will extend to 3 months for oral contraceptive use) and for at least 30 days after the last dose of study drug. For a subject to be considered not to be of child-bearing potential, she must have been amenorrheic for at least 2 years, or must have had a hysterectomy, a bilateral tubal ligation, and/or a bilateral oophorectomy (as determined by the medical history). The male partner of a female study subject with childbearing potential must use a condom and ensure that his partner uses a suitable method of contraception as outlined above.
Subjects who are inappropriate to participate in this study, as judged by the clinical investigator
Subjects who have been tested positive for the following tests:
- Human immunodeficiency virus (HIV)
- Hepatitis B virus (HBV)
- Hepatitis C virus (HCV)
Everfront Biotech Co., Ltd.Taiwan