KCT0001742已完成未知
A Phase I Single-center, Randomized, Double-blind, Placebo-controlled Study in Healthy Volunteers to evaluate the Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses and Multiple Doses of SP-8203
Shin Poong Pharm0 个研究点目标入组 72 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 72
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
- 20(Year) 至 45(Year)（—）
- 性别
- All
入选标准
- •1. Subject is male or female between the ages of 20 and 45 years, inclusive.
- •2. Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or post-menopausal. Non-pregnancy will be confirmed by serum pregnancy tests conducted at Screening, CRU admission, and at the Follow-Up Visit.
- •3. Males must be agree to practice a medically acceptable method of birth control and will not donate sperm during the study.
- •4. Subject’s body mass index (BMI) is = 18 kg/m2 and = 32 kg/m2, inclusive.
- •5. Subject does not smoke and has not smoked or used nicotine-containing products for at least 180 continuous days prior to the first dose.
- •6. Subject has adequate venous access for repeated venipuncture.
- •7. Subject has hemoglobin = 11.5 g/dL.
- •8. Subject agrees to abstain from taking any dietary supplements or non-prescription drugs (except for multi-vitamins, or as otherwise authorized by the Investigator and Medical Monitor) for 14 days prior to CRU admission through discharge.
- •9. Subject agrees to abstain from consuming alcohol-containing beverages for 3 days prior to CRU admission through discharge.
- •10. Subject agrees to abstain from consuming caffeine- or chocolate-containing products from CRU admission through discharge.
- •11. Subject is in general good health based on medical history and clinically acceptable results on the following assessments: physical examination, vital signs, 12 lead ECG, clinical chemistry, hematology/coagulation, and urinalysis.
- •12. Seated systolic blood pressure must be > 90 mmHg and = 140 mmHg and seated diastolic blood pressure must be >50 mmHg and = 90 mmHg at Screening and Baseline.
- •13. Subject voluntarily provides written informed consent to participate in the study in English, or a local language understood by both the investigator and subject. Subject is able to communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
排除标准
- •1. Subject has a history or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- •2. Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically important idiosyncratic reaction to any drug.
- •3. Subject has a predisposing condition that could interfere with the distribution, metabolism, or excretion of drugs or any condition that may confound the Pharmacokinetics(PK) analyses.
- •4. Subject tests positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C virus.
- •5. Subjects that have chronic QT prolongation syndrome (i.e. QTc > 450 ms for males and > 470 ms for females) in repeated Electrocardiography(EKG) measurements.
- •6. Subject used any drugs or substances known to inhibit or induce cytochrome P450 2D6 (CYP) enzymes within 28 days prior to the first dose and throughout the study.
- •7. Subject has a recent (2-year) history of alcoholism or drug abuse.
- •8. Subject tests positive for alcohol or drugs of abuse at the Screening Visit or upon admission to the CRU.
- •9. Subject has been on a special diet during the 28 days prior to the first dose (eg, Atkins, South Beach, or any other high protein / high fat diets).
- •10. Subject reports difficulty fasting or consuming standardized meals.
- •11. Subject has donated of plasma (apheresis) within 30 days and whole blood within 60 days prior to the first dose of study medication.
- •12. Subject who participated in another clinical trial within 90 days prior to dosing.
- •13. Subject has a history of malignancy within the past 5 years, with the exception of successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin and/or localized carcinoma in situ of the cervix.
- •14. For any other reason that investigator believes the subject is not suitable to participate.
研究者
相似试验
已完成
不适用
A Phase I, single*center, double-blind, randomized, placebo-controlled, single and multiple ascending dose trial to evaluate the safety and pharmacokinetics of PTC857 in healthy volunteers.10007951Parkinson's DiseaseNL-OMON49571PTC Therapeutics, Inc.82
已完成
1 期
A study of ALMB-0166 administered intravenously to assess tolerability and metabolism of the study drug in healthy participants.Spinal cord injuryInjuries and Accidents - Other injuries and accidentsACTRN12619001689167Avance Clinical Pty Ltd46
尚未招募
1 期
A Phase 1, Single Centre, Randomized, Double Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NeuroDirect Ketamine in Healthy Adult VolunteersMental Health - Other mental health disordersPost-traumatic stress disorderACTRN12623000061639Psycheceutical, Inc24
尚未招募
不适用
A single-center, double-blind, randomized, phase I/II dose escalating study to assess the safety, tolerability and immunogenicity of three doses of the therapeutic synthetic long peptide (SLP) vaccine (ISA104) in patients with chronic hepatitis B (cHBV).chronic hepatitis BcHBV10047438NL-OMON51362Erasmus MC, Universitair Medisch Centrum Rotterdam24
已完成
1 期
A Phase I, Single Centre, Double Blind, Randomised, Placebo Controlled, Single Escalating Dose Study to Determine the Safety, Tolerability and Absorption of Ha44 Administered Topically to the Hair and Scalp of Healthy VolunteersHealthy subjectsOther - Research that is not of generic health relevance and not applicable to specific health categories listed aboveACTRN12607000014459Hatchtech Pty Ltd32