NL-OMON54986已完成不适用
TBAJ-587-CL-001, Phase 1, Partially Blinded, Placebo-Controlled, Randomized, Combined Single Ascending Dose with Food Effect Cohort Trial (Part 1) and Multiple Ascending Dose Trial (Part 2) to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBAJ-587 in Healthy Adult Participants. - CS0345-190557 TB Alliance
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
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 99（—）
入选标准
- •Provide written, informed consent prior to all trial-related procedures.
- •Healthy adult male and females of non-childbearing potential, 18-64 years of
- •age (inclusive) at the time of screening.
- •Body mass index (BMI) >= 18.5 and <= 32.0 (kg/m2) and a body weight of no less
- •than 50.0 kg.
- •Medically healthy with no clinically significant screening results (e.g.,
- •laboratory profiles normal or up to Grade 1 per FDA Toxicity Tables), medical
- •histories, vital signs, ECGs, physical examination findings, as deemed by the
- •Investigator. Lab results within the testing facilities normal range will not
- •be considered AEs when referenced to the FDA Toxicity Scales (Appendix 2)
- •assessment/grading scale. If exclusionary lab criteria are met, values may be
- •confirmed by repeat evaluation
排除标准
- •History or presence of significant cardiovascular abnormalities, Heart Murmur,
- •pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine,
- •immunologic, dermatologic, neurological, or psychiatric disease as determined
- •by the Investigator to be clinically relevant.
- •Any musculoskeletal toxicity (severe tenderness with marked impairment of
- •activity) or musculoskeletal toxicity (frank necrosis).
- •History of any illness that, in the opinion of the Investigator, might confound
- •the results of the trial or poses an additional risk to the participant by
- •their participation in the trial.
- •Surgery within the past 90 days prior to dosing or other previous surgery as
- •determined by the Investigator to be clinically relevant.
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