NL-OMON51736已完成不适用
A first-in-human, participant and investigator-blinded, randomized, placebo-controlled, single and multiple-ascending dose study with drug-drug interaction, to investigate the safety, tolerability, and pharmacokinetic profile of AB521, in healthy volunteers. - Safety, PK and PD of AB521 in healthy volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
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 64（—）
入选标准
- •1. Capable of giving signed informed consent which includes compliance with the
- •requirements and restrictions listed in the informed consent form (ICF) and in
- •this protocol.
- •2. Participant must be at least 18 to 55 years of age inclusive, at the time of
- •signing the informed consent.
- •3. Participants who are healthy volunteers (in the opinion of the investigator)
- •as determined by pre-study medical history, physical examination, vital signs,
- •and 12-lead ECG.
- •4. Participants must have clinical laboratory tests within the reference range
- •for age and gender at screening and baseline.
- •5. Screening and randomization hemoglobin for males and females is as follows:
- •a) SAD: male and female hemoglobin level >= 12.5 g/dL (7.7 mmol/L)
- •b) MAD and DDI: male hemoglobin level >= 14.2 g/dL (8.8 mmol/L) and female
- •hemoglobin level >= 12.5 g/dL (7.7 mmol/L).
- •Further criteria apply
排除标准
- •1. Has any (acute or chronic [including SARS-CoV-2 infection]) medical or
- •psychiatric condition that, in the opinion of the investigator, could
- •jeopardize or would compromise the study participant*s ability to participate
- •in this study.
- •2. Has history or presence of cardiovascular, respiratory, hepatic, renal,
- •gastrointestinal, endocrinological, hematological, cerebrovascular,
- •neurological, or other major disorders capable of significantly altering the
- •absorption, metabolism, or elimination of IMP; constituting a risk when taking
- •the study intervention; or interfering with the interpretation of data in the
- •opinion of the investigator.
- •3. Abnormal blood pressure (BP) or pulse measurements at the Screening Visit or
- •Day -2/-1 (Admission) in a supine position after 5 minutes of rest as follows:
- •mean systolic BP >= 139 mm Hg or mean diastolic BP >= 89 mm Hg; mean pulse < 40
- •bpm or > 100 bpm. Study participants with a BP within normal range but who, in
- •the opinion of the investigator, have a high risk for cardiovascular accident
- •based on, eg, family history, smoking, BMI, or lipid spectrum can be excluded.
- •Results that are outside the specified ranges and are deemed clinically
- •non-significant will be allowed at the discretion of the investigator, after
- •discussion with the Sponsor Medical Monitor (or designee). If a study
- •participant has a test result outside the normal range that is deemed
- •potentially clinically significant, repeat of the investigation may be allowed
- •once at the discretion of the investigator, after discussion with the Sponsor
- •Medical Monitor (or designee).
- •4. The following liver enzyme test results:
- •a) Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin,
- •or alkaline phosphatase (ALP) >1.0× upper limit of normal (ULN).
- •Tests that result in ALT, AST, bilirubin, or ALP up to 25% above the
- •exclusion limit may be repeated once for confirmation.
- •b) Current or chronic history of liver disease or known hepatic or biliary
- •abnormalities (with the exception of asymptomatic gallstones).
- •5. Has 12-lead ECG with changes considered to be clinically significant (eg,
- •QTcF > 450 msec for males and > 470 msec for females, left bundle branch block,
- •or evidence of myocardial ischemia) at the Screening Visit or Day -2/-1
- •(Admission).
- •Further criteria apply
研究者
相似试验
进行中（未招募）
1 期
First in human study to assess the safety, tolerability and pharmacokinetics of EDI048 in healthy volunteersCryptosporidium infectionsInfections and InfestationsCryptosporidiosisISRCTN38693215ovartis Pharma AG (Switzerland)80
尚未招募
4 期
A study in people who require facial enhancement through dermal filler (JEUNESSO 30L).CTRI/2021/12/039025Dr Debraj Shome
已完成
4 期
A study in people who require facial improvement through dermal filler (JEUNESSO20L)CTRI/2023/03/050208Dr. Hemant Talanikar122
尚未招募
Unknown
A trial to evaluate the investigational device used for early prediction of response to neoadjuvant chemotherapy in breast cancer patients using Discrete Multi-Wavelength Near Infra-Red Spectroscopy (DMW-NIRS)KCT0008798Asan Medical Center60
已完成
2 期
Ketoji a nutritional therapy in management of symptoms of Covid-19 patients.CTRI/2021/03/031790Department of Pharmaceutical Sciences Guru Nanak Dev University Amritsar60