CTRI/2024/06/068347招募中1 期
A phase 1/2, prospective, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of single and multiple ascending doses of intravenously administered ZRC-NB-3224 in healthy adult participants and in patients with paroxysmal nocturnal hemoglobinuria - NI
Zydus Lifesciences Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
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
入选标准
- •Single ascending dose study:
- •1.Male and non-pregnant, non-lactating, female participants aged 18 to 50 years at screening (both inclusive).
- •2.Body mass index between 18.5 to 29.9 kg/m2 (both inclusive) and body weight =50 kg at screening.
- •3.Ability to communicate effectively with study personnel.
- •4.Be able to give consent for participation in the trial.
- •5.Healthy as determined based on personal medical/surgical history, physical examination, ECG, and laboratory assessment data during screening (within the clinically acceptable range).
- •6.Vaccinated against Neisseria meningitides with meningococcal group ACWY conjugate vaccine and meningococcal group B vaccine, Streptococcus pneumoniae, Haemophilus influenzae
- •7.Female participants with a history of sterility or at least 1 year menopause or use of long-acting non-hormonal contraceptive measures (e.g., intrauterine device). Those who are willing and able to continue contraception till study completion after administration of study treatment.
- •8.Men who agree to use adequate contraception methods during the study and are willing and able to continue contraception till study completion after administration of study treatment.
- •Multiple ascending dose study:
- •1.Male and non-pregnant, non-lactating female participants aged 18 to 65 years at screening (both inclusive).
- •2.Body mass index between 18.5 to 29.9 kg/m2 (both inclusive).
- •3.Treatment naïve patients (no history of complement-directed therapy) or stable regimen (dose and intervals) of any treatment (either eculizumab, ravulizumab, or any other treatment) for at least 3 months prior to screening and till study drug administration.
排除标准
- •Single ascending dose study:
- •1.History of alcohol consumption or tobacco use or drug abuse within past 1 year of enrolment or participant currently consuming alcohol and/or tobacco products.
- •2.Presence or history of any of the disorder/disease within the past 3 months that might have an impact on the clinical trial as per the investigator’s discretion i.e., cardiovascular, nervous system, gastrointestinal, respiratory or any other major disorder.
- •3.Presence or suspicion of active viral, bacterial, fungal, or parasitic infection within 14 days before administration of the first dose of study drug.
- •4.Difficulty in donating blood.
- •5.Systolic blood pressure more than 140 mmHg or lesser than 100 mmHg and diastolic blood pressure more than 90 mmHg or less than 60 mmHg.
- •Multiple ascending dose study:
- •1.Known or suspected hereditary or acquired complement deficiency.
- •2.History of clinically significant arterial or venous thrombosis.
- •3.History of hematopoietic stem cell transplantation.
- •4.Active malignancy and/or history of malignancy in the past 5 years.
- •5.Prior splenectomy.
- •6.Treatment with another investigational product within 30 days.
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