ACTRN12617000369325已完成1 期
A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANB019 in Healthy Subjects and Psoriasis Patients.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 87
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
- •For the healthy participants cohorts - healthy male and female as determined by a lack of clinically significant medical history, physical examination, ECGs, and clinical laboratory determinations.
- •For the plaques psoriasis cohort - male and female participants as determined by lack of clinically significant medical history other than clinically diagnosed moderate to severe plaque psoriasis.
排除标准
- •1) Medical History and Concurrent Diseases:
- •a)Any significant acute or chronic medical illness.
- •b)Presence of any factors that would predispose the subject to develop infection e.g., rectal fissures, poor dentition, open skin lesions, and presence of pre-existing skin conditions that increase risks for injection site complications e.g. Behcet’s Disease, Psoriasis, pustular dermatoses.
- •c)Current or recent (within 3 months of study drug administration) gastrointestinal disease.
- •d)Previous administration of mAbs
- •2) Psoriasis Patients
- •a)Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug.
- •b)Have applied any topical medication (including corticosteroid, calcineurin inhibitor,topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation within 21 days prior to Day -1.
- •c)Have received antibiotic treatment within 1 week prior to study entry.
- •d)Within 4 weeks prior to study entry, have received systemic treatment for psoriasis (including systemic corticosteroids, non-steroidals, immunosuppressants, or immunomodulating drugs) or treatment with UV light.
- •e)Have received any investigational drug or been part of any clinical trial within a period of three months or five half-lives (whichever is longer) prior to study entry.
- •f)Previous treatment with anti-tumour necrosis factor (TNF)/interleukin (IL-12/IL-23) and IL-17 or any other monoclonal antibodies is not allowed within 3 months or 5 half-lives or twice the duration of the biological effect of the product prior to Day -1.
- •3) Physical and Laboratory Test Findings:
- •a)Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
- •4) Allergies and Adverse Drug Reaction
- •a)History of any significant drug allergy or reaction (such as anaphylaxis or hepatotoxicity) and reactivity to polysorbate 20 a component of ANB019 formulation, or the inactive ingredients (excipients)
研究者
相似试验
终止
1 期
A Study of AB-161 Following Oral Administration in Healthy SubjectsHepatitis BInfection - Other infectious diseasesACTRN12623000074695Arbutus Biopharma Corporation20
已完成
1 期
A Single and Multiple Dose Study to Determine the Safety and Tolerability of GBT021601 in Healthy Adult Volunteers - Part ABlood - Haematological diseasesHuman Genetics and Inherited Disorders - Other human genetics and inherited disordersSickle Cell DiseaseACTRN12620001324909inear Clinical Research Ltd64
撤回
1 期
A Study to investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AB-452 in Healthy Subjects and Subjects with Chronic HBV InfectioACTRN12618001438246Arbutus Biopharma Corporation76
终止
1 期
A study to investigate the Safety, Tolerability, and Pharmacokinetics of AB-506 in Healthy Subjects and Subjects with Chronic HBV InfectioChronic HBV InfectionInfection - Other infectious diseasesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonACTRN12618000987268Arbutus Biopharma Corporation57
已完成
1 期
A Study of JNJ-75220795 in Japanese ParticipantsFatty LiverJPRN-jRCT2071210066akano Masayoshi27