NCT05794516已完成1 期
A Single Ascending Dose (SAD) Study to Evaluate the Safety and Pharmacokinetics (PK) of ZB004 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAEs) to evaluate Safety and Tolerability of ZB004
研究概览
简要总结
The purpose of this study is to evaluate the safety and pharmacokinetics of single-ascending doses of ZB004.
详细描述
Up to approximately 40 healthy volunteers across 5 cohorts randomized to receive ZB004 or placebo as single doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female participants 18 to 55 years of age.
- •Body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants; body mass index of 18 to 35 kg/m^2 for both male and female participants.
- •Considered in good health as determined by the Investigator.
- •Female participants of child-bearing potential must agree to abstinence or use an highly effective form of contraception. Female participants must also refrain from donation of eggs from the signing of the informed consent to 6 months after receiving their dose of study drug.
- •Male participants must be surgically sterile or agree to use effective contraception. Male participants must also agree not to donate sperm from the signing of the informed consent to 6 months after the last scheduled dose of the study drug.
- •Willing and able to understand the characteristics and purposes of the study, including possible risks involved, and willing to comply with all the study requirements and provide written informed consent for the study.
排除标准
- •Surgery within 4 weeks before Screening or planned surgery during the clinical study.
- •Use of prescription medications, biological products, or other medicines within 2 weeks before Study Day 1 or 5 half-lives of the product, whichever is greater. Use of over-the-counter medications or vitamins/dietary supplements within 7 days of dosing unless considered by the Investigator to not pose a risk or impact the study results.
- •Clinically significant ECG abnormality.
- •Positive for HIV, active hepatitis C or B, Covid-19 virus, tuberculosis.
- •Bacteria, viruses, systemic fungi, parasites, or other opportunistic infections within 30 days before Study Day
- •History of drug abuse in the previous 12 months before Screening, or positive for urine drug Screening (Day -28 to Day -1).
- •Donated blood (including component blood) or lost > 400 mL within 3 months before Screening or received a transfusion within 3 months of Screening.
- •History of relevant allergies (including allergy to any murine or human-derived protein or immunoglobulin products, rubber or latex, or other allergies that in the opinion of the Investigator make inclusion in the study inappropriate).
- •Average daily smoking > 10 cigarettes/day (or equivalent) within 6 months of Screening.
- •Consume > 14 standard units of alcohol per week (1 standard unit is equivalent to approximately 360 mL of beer, 45 mL of spirits with 40% alcohol, or 150 mL of wine) or a positive alcohol breath test on Day -
- •Any disease that might interfere with the safety evaluation of the investigational product.
研究组 & 干预措施
ZB004
Experimental
干预措施: ZB004 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs) to evaluate Safety and Tolerability of ZB004
时间窗: Day 1 through Day 99
次要结局
- Apparent clearance following extravascular dosing (CL/F)(Day 1 through Day 99)
- Number of participants with Electrocardiogram (ECG) abnormalities(Day 1 through Day 99)
- Maximum observed serum concentration (Cmax)(Day 1 through Day 99)
- Time for Cmax (Tmax)(Day 1 through Day 99)
- Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf)(Day 1 through Day 99)
- Terminal half-life (t½)(Day 1 through Day 99)
- Number of participants with treatment-emergent serious adverse events (SAEs)(Day 1 through Day 99)
- Number of participants with laboratory abnormalities(Day 1 through Day 99)
- AUC from time 0 to the last quantifiable concentration (AUClast)(Day 1 through Day 99)
- Apparent volume of distribution following extravascular administration (Vz/F)(Day 1 through Day 99)
研究者
研究点 (1)
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