ACTRN12623001233617招募中1 期
A Randomized, Phase 1, Double-blind, Placebo-Controlled, 2-Part, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of KER-065 Administered to Healthy Adult Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 38
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
- •1. Body mass index (BMI) of greater than or equal to 18.5 through less than or equal to 35 kg per m2 at the Screening Visit for Part 1 (SAD) only. BMI of greater than or equal to 27 to less than or equal to 35 kg per m2 at the Screening Visit for Part 2 (MAD) only.
- •2. For Part 2 (MAD) only: waist to hip ratio of greater than or equal to 0.9 and body weight of less than 101 kg at screening visit.
- •3. Willing to maintain current level of physical activity and will not have major changes in activity (including extremely strenuous or unusual exercise) during Screening and for the duration of the study.
排除标准
- •1. Clinically significant illness (as determined by the Investigator or delegate) such as cardiovascular, endocrine, hematologic, hepatic, immunologic, metabolic, gastrointestinal, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases or abnormalities that may affect safety or confound the results of the study.
- •2. History of bariatric surgery including gastric bypass or gastric sleeve surgery.
- •3. Malignancy or treatment for malignancy within 3 years before Screening (with the exception of fully excised or treated basal cell carcinoma, or no more than 2 fully treated squamous cell carcinomas of the skin). Participants with a history of malignancy who are
- •disease-free without treatment for greater than or equal to 3 years are eligible.
- •4. Serious local infections (e.g., cellulitis, abscess), opportunistic infections (e.g., invasive candidiasis or Pneumocystis pneumonia), or systemic infection (e.g., septicemia) within the 3 months before Screening.
- •5. Fever (body temperature greater than or equal to37.7°C) or symptomatic viral (including COVID-19, respiratory syncytial virus, influenza) or bacterial infection within 2 weeks before Screening.
- •6. Major surgery within 3 months before Screening.
- •7. Donated or lost blood (450 mL or more) or blood products within 30 days before dosing or plans to donate blood or blood products during the study.
- •8. Systemic corticosteroid therapy for more than 4 weeks within the 6 months before Screening.
- •9. Positive screening test for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus.
- •10.Indwelling permanent pacemakers, metal implants, or similar materials not suitable for DXA or MRI scan. Metal dental fillings are acceptable.
研究者
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