ACTRN12622000344796招募中1 期
A Phase 1/1b, Three-Part, Randomised, Placebo-Controlled, Single- and Multiple-Ascending-Dose Studyto Evaluate the Safety, Pharmacokinetics, and Activity of SZN-1326 in Healthy Volunteers and in Subjects with Moderate to Severe Ulcerative Colitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- 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 50 Years（—）
- 性别
- All
入选标准
- •1. Be a healthy male or female adult.
排除标准
- •1.Is pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
- •2.Has previously received antibody or biologic therapy whether licensed or investigational (immunoglobulin products, monoclonal antibodies or antibody fragments) within the past 6 months.
- •3.Has received treatment with any experimental drug within 30 days prior, or within five half-lives, prior to Day 0 visit (Baseline), whichever is longer.
- •4.Has a history of hyperthyroidism, Paget’s disease, osteomalacia, or a fracture within 4 weeks of Screening.
- •5.Has a history of a previous severe allergic reaction with generalized urticaria, angioedema or anaphylaxis.
- •6.Has clinically significant abnormalities on ECG.
- •7.A QT duration corrected for heart rate by Fridericia's formula (QTcF) >450 msec for males and >470 msec for females based on either single or averaged QTcF values of triplicate?ECGs prior to study drug administration (Part 1 only)
- •8.Has a history of malignant neoplasm, except for adequately treated non-metastatic basal or squamous cell cancers of the skin (>1 year ago) or carcinoma in situ of the uterine cervix (>3 years ago) that has been fully treated and shows no evidence of recurrence. Subjects under evaluation for possible malignancy are not eligible.
- •9.Has a first degree relative with colorectal cancer.
研究者
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