NL-OMON49571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. - CS0346-200065 PTC-857
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Healthy male or female subjects aged from 18 to 55 years old, inclusive, at
- •Subjects must understand the nature of the study and must provide signed and
- •dated written informed consent before the conduct of any study-related
- •procedures.
- •BMI of * 19.0 kg/m2 and * 35.0 kg/m2 with a body weight * 50.0 kg for male
- •subjects and a body weight * 45.0 kg for female subjects at Screening.
- •Healthy as determined by the Investigator, based upon a medical evaluation
- •including medical history, physical examination, laboratory tests, triplicate
- •ECG recording (average QTcF * 450 msec) and vital signs. Out of range values
- •can be repeated once.
排除标准
- •History of coagulopathy.
- •History of fat malabsorption.
- •Dietary restrictions that preclude participation.
- •Females who are pregnant or nursing.
- •Subjects with a prior medical history of clinically significant
- •gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine,
- •oncologic, pulmonary, immunologic,psychiatric, or cardiovascular disease or any
- •other condition which, in the opinion of the Investigator, would jeopardize the
- •safety of the subject or impact the validity of the study results.
研究者
相似试验
尚未招募
1 期
Treatment of abnormal uterine bleedingAbnormal Uterine BleedingPACTR202310719625892Avana Health20
已完成
1 期
A phase 1 study to evaluate the safety, tolerability and pharmacokinetics of ascending multiple oral doses of XW10172 in healthy adult subjectsarcolepsyNarcolepsyInflammatory and Immune System - Autoimmune diseasesNeurological - Other neurological disordersACTRN12618001038280XW Laboratories (Australia) Pty Ltd24
已完成
1 期
A phase 1 study to evaluate the safety, tolerability and pharmacokinetics of ascending single oral doses of XW10172 in healthy adult subjectsACTRN12618000127202XW Laboratories (Australia) Pty Ltd50
已完成
不适用
A phase 1, single center, randomized, double-blind, placebo-controlled, single (Part 1) and multiple (Part 2) ascending dose study to evaluate the safety,tolerability, pharmacokinetics and pharmacodynamics of M281 administered to healthy volunteers.auto-immuunziekten en ontstekingsziekten.autoimmune diseases and inflammatory diseasesNL-OMON43123Momenta Pharmaceuticals, Inc.74
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