A Phase I, Partially Blind (Observer-blind), Randomized, Single Dose Ascending Study of Dengue Monoclonal Antibody (Dengushield) in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The proportion of participants with post-injection/ infusion adverse events (AEs) including hypersensitivity reaction, anaphylactic reaction and other AEs occurring within 4 hours of the start of dosing
研究概览
简要总结
This Phase 1 study to evaluate the safety of a single dose of Dengushield (dengue monoclonal antibody) in healthy adults.
详细描述
This Phase 1 study will evaluate the safety and tolerability of a single dose of Dengushield (dengue monoclonal antibody) in healthy adults in a dose-escalating study design. In addition, pharmacokinetics will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
For the Cohort 1 (Initial Safety Cohort), no placebo control will be used and hence, blinding is not applicable.For remaining cohorts, both participant and investigator will be unaware of treatment allocation as well as the laboratories analyzing the biochemistry and hematology parameters, pharmacokinetic and immunogenicity (ADA) samples will be blinded to treatment allocation. The drug administrator will be unblinded who will prepare and administer the study drugs. The 7 day safety data for each cohort will be reviewed by group-wise unblinding. Individual level unblinding will be done only in cases of suspected serious adverse reactions as per the judgement of investigator or medical monitor / sponsor representative.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18-45 years, men, or women.
- •Negative Dengue NS1 at screening indicating no current dengue infection
- •Seronegative for dengue IgG
- •Participants who are willing to comply with the requirements of the study protocol and attend scheduled visit.
- •Participants who give written informed consent.
- •Participants having laboratory parameters within normal range
- •Participants with Body Mass Index (BMI) between 18 to 30 (both inclusive)
- •Satisfactory baseline medical assessment as assessed by physical examination and normal laboratory values or minor variations that is acceptable for study entry.
排除标准
- •Presence of acute infection in the preceding 14 days or presence of a temperature ≥ 38.0°C, or acute symptoms of infection greater than of "mild" severity on the scheduled date of first dosing
- •History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, dermatologic or immunosuppressive disorders.
- •Evidence of any other significant active haematological disease, or having donated > 450 mL of blood within the past three months.
- •Evidence or history of substance abuse including alcohol, or previous substance abuse within the last year.
- •Participation or planned participation in a study involving the administration of an investigational compound within the past one month or during this study period.
- •Planned administration of any vaccine not foreseen by the study protocol 4 weeks before and after dosing except for influenza vaccination.
- •Receipt of immunoglobulins and/or any blood products within 9 months of study enrolment or planned administration of any of these products during the study period.
- •Laboratory confirmed infection with hepatitis B virus (HBsAg positive), hepatitis C virus (anti-HCV positive) or human immunodeficiency virus (HIV positive) at screening.
- •History of allergic disease, allergic reactions or known hypersensitivity to any component of the study product (Mild non-medication allergies allowed).
- •Known bleeding disorders.
- •Women who are pregnant, breast-feeding, or considering becoming pregnant.
- •Any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the participant.
结局指标
主要结局
The proportion of participants with post-injection/ infusion adverse events (AEs) including hypersensitivity reaction, anaphylactic reaction and other AEs occurring within 4 hours of the start of dosing
时间窗: 4 hours post administration of drug
Safety monitoring for 4 hours
The proportion of participants with AEs, discontinuations due to AEs, and serious adverse events (SAEs)
时间窗: 84 days
Safety
Proportion of participants with clinically significant abnormal safety laboratory (hematology and chemistry parameters) findings
时间窗: 28 days
Safety
次要结局
- Time to maximum serum concentration of Dengushield - Tmax(84 days)
- Presence or absence of anti-Dengushield antibody in sera samples(84 days)
- Maximum serum concentration of dengushield - Cmax(84 days)
- AUC from time 0 to infinity of Dengushield(84 days)
- AUC from time 0 to 84 days of Dengushield(84 days)
- Volume of distribution of Dengushield(84 days)
- Elimination rate constant of dengushield(84 days)
- Clearance of dengushield(84 days)
- Half life of Dengushield - t1/2(84 days)