NCT06097702已完成1 期
A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BX-001N After Intravenous Administration in Healthy Participants
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Number of participants with Treatment emergent Adverse events (TEAEs)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, single and multiple ascending dose, Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of BX-001N after intravenous administration in approximately 64 healthy participants
详细描述
This study comprises of 2 parts:
- Part 1- Single Ascending Dose (SAD)- This part will enroll approximately 40 participants across 5 cohorts where each participant will receive a single intravenous (IV) bolus dose in healthy participants. On Day 1, participants in each cohort will receive investigational product (IP) (i.e., BX-001N or Placebo) as a single IV bolus following a minimum 8-hour fast.
- Part 2 -Multiple Ascending Dose (MAD)- This part will enroll approximately 24 participants across 3 cohorts where each participants will receive intravenous (IV) bolus dose for 4 sequential daily. At the same time each morning from Day 1 to Day 4 (inclusive), participants in each cohort will receive IP (i.e., BX-001N or Placebo) as a single IV bolus following a minimum 8-hour fast.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 50 years of age
- •In good general health at Screening and/or before the first administration of IP
- •BMI > 18.0 and < 32.0 kg/m2 at Screening
- •Nonsmoker and must not have used any tobacco products within 2 months prior to screening
- •Females must not be pregnant or lactating, and females and males must use acceptable, highly effective double contraception during study and follow-up period
- •Person who can provide written informed consent prior to the commencement of all study procedures
排除标准
- •Underlying physical or psychological medical condition to comply with the protocol or complete the study per protocol
- •Genetic disorder with severe and abnormal bilirubin metabolism
- •Blood or plasma donation or significant blood loss prior to the first administration of IP
- •Viral or bacterial infection prior to the first administration of IP
- •Poor venous access
- •Significant scarring or tattoos at the planned site of IP administration
- •History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents
- •History or active cardiovascular, respiratory, kidney, endocrine, blood, digestive, central nervous, urinary and/or musculoskeletal disease
- •History of malignancy prior to Screening
- •Abnormal ECG findings
- •History or presence of a condition associated with significant immunosuppression
- •History of life-threatening infection
- •Infections requiring parenteral antibiotics
- •Vaccination prior to the first administration of IP
- •Exposure to any significantly immune suppressing drug
- •Abnormal vital signs findings
- •Abnormal laboratory findings
- •Positive results for viral testing at Screening
- •Positive result at Screening and Day -1 for toxicology screening panel
- •History of substance abuse or dependency or history of recreational intravenous (IV) drug use
- •Excess of regular alcohol consumption
- •Use of any IP or investigational medical device within 30 days prior to Screening
- •Unable to adhere to the prohibited therapies
- •Unwilling to adhere to the dietary restrictions
- •Unwilling to refrain from strenuous exercise
研究组 & 干预措施
BX-001N Part 1
Experimental
Part 1 is SAD with 5 cohorts where each participant will receive single IV bolus following a 8hr fast.
干预措施: BX-001N Part 1 (Drug)
BX-001N Part 2
Experimental
Part 2 is MAD with 3 cohorts where each participant will receive 4 sequential daily IV bolus doses following a 8hr fast.
干预措施: BX-001N Part 2 (Drug)
Placebo
Placebo Comparator
Matching doses of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with Treatment emergent Adverse events (TEAEs)
时间窗: SAD-Screening to Day 7; MAD- Screening to Day 14
TEAE will be collected to assess participants' safety after BX-001N treatment
Number of participants with clinical laboratory abnormalities
时间窗: SAD-Screening to Day 7; MAD- Screening to Day 14
Number of participants with changes in the 12-lead electrocardiogram (ECG)
时间窗: SAD-Screening to Day 7; MAD- Screening to Day 14
Number of incidences of injection site reactions
时间窗: SAD-Day 1 to Day 2; MAD- Day 1 to Day 5
次要结局
- Changes in Cmax (maximum Concentration) of BX-001N with 5 different doses of SAD and 3 different doses of MAD(SAD- Day 1 to Day 7; MAD- Day 1 to Day 14)
- Changes in Tmax (Time of maximum Concentration) of BX-001N with 5 different doses of SAD and 3 different doses of MAD(SAD- Day 1 to Day 7; MAD- Day 1 to Day 14)
- Changes in AUC (area under curve) of BX-001N with 5 different doses of SAD and 3 different doses of MAD(SAD- Day 1 to Day 7; MAD- Day 1 to Day 14)
- Change in Immunogenicity- Incidence of Anti-drug antibody (ADA) by polyethylene glycol (PEG)(SAD-Day 1 to Day 7; MAD- Day 1 to Day 14)
- Change in Immunogenicity- Titers of Anti-drug antibody (ADA) by polyethylene glycol (PEG)(SAD-Day 1 to Day 7; MAD- Day 1 to Day 14)
- Change in Immunogenicity- Duration of Anti-drug antibody (ADA) by polyethylene glycol (PEG)(SAD-Day 1 to Day 7; MAD- Day 1 to Day 14)
研究者
研究点 (1)
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