ACTRN12623001265662招募中1 期
A Phase 1, Randomized, Placebo-Controlled, Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of PLX-4545 in Healthy Subjects
Plexium Australia Pty Ltd0 个研究点目标入组 96 人开始时间: 2023年12月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •A participant is eligible for inclusion in this study if all of the following criteria are met:
- •- Male or female subjects 18 years to 65 years old at the time of informed consent.
- •- Must have a body mass index of 18.5 to 32.0 kg/m2, inclusive, and weigh at least 50 kg at Screening.
- •- Must be otherwise healthy and free from illness or disease as determined by medical history, vital signs, physical examinations, ECGs, laboratory studies, and/or other tests performed within 28 days prior to drug administration, as judged by the Investigator.
- •- Must be able to swallow capsules.
- •- Must be willing and able to understand the study procedures and comply with all aspects of the protocol and confinement periods.
- •- Must be able to give signed informed consent and any locally required authorization prior to any protocol-related procedures.
排除标准
- •Participants are not eligible for this study if any of the following criteria apply:
- •- Has presence or history of hypersensitivity to murine proteins or any drug or other allergies which are considered, in the opinion of the Investigator, to contraindicate study participation.
- •- Has recently received any vaccination within 12 weeks prior to randomization, or who intends to receive a live vaccination during the study.
- •- Is known to be seropositive for human immunodeficiency virus (HIV).
- •- Has a positive result for hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen, or antibody to hepatitis C virus (HCV).
- •- Use of any investigational drug or product, or participation in an investigational drug study within 30 days prior to dosing or 5 half-lives of the drug (whichever is longest).
- •- Has previous exposure to antibody therapies within 6 months or administration of immunoglobulins within 6 months prior to study drug administration.
- •- Has a history of donating 1 unit of blood (450 mL) in the 3 months prior to study drug administration or who intends to donate within 3 months of their last scheduled study visit.
- •- Has a history of hypertension or a blood pressure >160/90 mmHg at Screening or a history of recurrent hypotensive events considered as clinically relevant or a blood pressure <95/50 mmHg at Screening.
- •- Is currently taking or who has taken any prescription or non-prescription medication within 7 days of study drug administration including aspirin, dietary or mega dose vitamin supplements, and herbal preparations (except paracetamol, hormone replacement therapies, and/or hormonal contraceptives).
- •- Active smoker and/or user of nicotine-containing products unless the participant agrees to discontinue smoking/use of nicotine-containing products from 2 weeks before first study drug administration through to study completion, including the Follow-up period.
- •- Has a history of febrile illness within 5 days prior to the first dose or symptoms of and active infection within 14 days prior to first dose.
- •- Unable to adhere to the required dietary restrictions
- •- Criteria, that in the opinion of the investigator, would interfere with the subject's participation in the study.
研究者
相似试验
已完成
1 期
A trial of BIT225 in patients with HIV-1 infection, to study the safety, concentration and distribution in the body, and anti-viral activity of the drug.ACTRN12612000696897Biotron Limited24
已完成
不适用
A Phase 1, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses Oral Doses of APX001, to Investigate the Effect of Food on APX001 and to Investigate the Drug-Drug Interaction Potential of APX001Fungal infectionNL-OMON45345Amplyx Pharmaceuticals, Inc.46
进行中（未招募）
1 期
BIIB115 in Healthy Volunteers and Pediatric SMA Patients Previously Treated with ZolgensmaSpinal muscular atrophyMedDRA version: 20.1Level: PTClassification code 10041582Term: Spinal muscular atrophySystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2022-000956-12-PLBiogen Idec Research Limited62
尚未招募
不适用
A Randomized, Blinded, Placebo-Controlled, Phase 1 Single Ascending Dose Study in Healthy Adult Male Volunteers and an Open-Label Multiple Ascending Dose Study in Pediatric SMA Participants Previously Treated with Onasemnogene Abeparvovec (Zolgensma*) to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB115SMASpinal muscular atrophy10029317NL-OMON53796Biogen Idec Research Limited42
招募中
1 期
BIIB115 in Healthy Volunteers and Pediatric SMA Patients Previously Treated with ZolgensmaSpinal muscular atrophyMedDRA version: 20.1Level: PTClassification code 10041582Term: Spinal muscular atrophySystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2022-000956-12-DEBiogen Idec Research Limited24