KCT0002390已完成未知
A Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GX-I7 in healthy volunteers
Genexine0 个研究点目标入组 50 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
- 50
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
- 19(Year) 至 45(Year)（—）
- 性别
- All
入选标准
- •1.Subject is willing and able to give informed consent after getting explanation on the clinical trials
- •2.Must be 19-45 years of age, inclusive
- •3.Weight 50-100kg, BMI of 18.0 kg/m2 or more, but less than 30.0 kg/m2
- •4.Subject who is adequately able to attend the study based on medical history and physical exam, no clinically significant abnormality from vital sign and clinical laboratory values
- •5.No clinical abnormality from ECG test
- •6.Non-smoker (no smoking or no use of any product containing nicotine at least for one month and negative from urine test)
排除标准
- •1.Suspected or confirmed malignancy, malignancy history
- •2.Any clinically significant acute or chronic medical condition requiring care of a physician, in liver, biliary tract, renal, nervous system (CNS or peripheral). respiratory system, endocrine (diabetes, hyperlipemia etc), cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction etc), hematology, malignancy, urinary disease, immune system (rheumatologic illness, lupus etc), otorhinolaryngologic diseases
- •3.Positive to HBsAg, HCV Ab and HIV Ab
- •4.Are considering or scheduled to undergo any surgical or dental procedure during the study
- •5.Administered other IP by attending bioequivalence study or other clinical study within recent 3 months
- •6.Any SAR against vaccines or antibiotics, any medical history with serious allergic diseases
- •7.Positive from urine drug screen or respiratory alcohol screen at medical screening or check-in
- •8.History of alcohol, drug, or substance abuse in the past 12 months
- •9.Consumption of alcohol within 48 hours prior to dosing
- •10.Medications with antacid, analgesic, herbal administration, vitamin, mineral (except maximum 4 grams of acetaminophen) hormone, steroids, insulin, hypoglycemic drug or other hormone substitute within 14 days before administration
- •11.Planning pregnancy or donation of sperm/disagreeing proper contraception during the study and 3 months following dosing
- •12.Do not have veins suitable for cannulation or multiple venepunctures
- •13.Any other factor that the Investigator thinks will increase subject risk with participation
研究者
相似试验
招募中
1 期
Phase 1 study of BRB-002 in healthy male volunteersCardiovascularCardiovascular - Other cardiovascular diseasesACTRN12624000405516Bitterroot Australia Pty Ltd48
已完成
不适用
A Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability of GX-I7 in HPV-infected female volunteersDiseases of The genitoruinary systemKCT0002389Genexine32
已完成
1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm Study of the Safety, Tolerability and Pharmacokinetics of Oral BTD-001 in Healthy VolunteersCognitive impairmentNeurological - Neurodegenerative diseasesACTRN12613000919718Balance Therapeutics Pty Limited30
招募中
1 期
A Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single dose of brincidofovir administered intravenously in healthy adult subjectsAdenoviruscytomegalovirussmallpoxInfection - Other infectious diseasesACTRN12616001657415Chimerix, Inc40
已完成
不适用
A phase 1, randomized, double-blind, placebo-controlled, multiple dose platform study investigating the immunopharmacology of EDP1815 and EDP2939NL-OMON51644Evelo Biosciences72