NCT07399132进行中（未招募）早期 1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part Study to Evaluate the Safety, Tolerability, and Immunogenicity of APL-10456-Vaccine in Healthy Volunteers
Apollo Therapeutics Ltd2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2026年2月16日最近更新:
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- To evaluate the safety and reactogenicity of APL-10456-Vaccine in healthy volunteers (HVs)
研究概览
简要总结
AP09CP01 is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part Study which is conducted in Australia. The main purpose of this research study is to evaluate the safety, side effects, and immune response of APL-10456-Vaccine, a Rhinovirus (RV) Vaccine, when compared with a placebo in Younger and Older Healthy Volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age Part A: Age ≥18 years and ≤54 years Part B: Age ≥55 years
- •Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
排除标准
- •History of severe allergic or anaphylactic reactions of any type
- •Acutely ill or febrile (temperature ≥38.0°C/100.4°F) 72 hours prior to or at the Day 1 visit
- •History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric or neurological disease/disorder within the past 3 months, or any acute minor illness (e.g. common cold, influenza, minor infection) within the past 1 month, determined by the PI (or delegate) to be clinically relevant
- •Reported history of congenital or acquired immunodeficiency
- •Dermatologic conditions that could affect local solicited AR assessments
- •Coagulopathy or a bleeding disorder that is considered a contraindication to IM injection or phlebotomy
- •Diagnosis of a malignancy within previous 5 years
- •Has received systemic immunosuppressants for >14 days in total within 180 days prior to the Randomization Visit
- •Has received or plans to receive any licensed or authorized vaccine, including COVID-19 vaccines, ≤28 days prior to the study injection (Day 1) or plans to receive a licensed or authorized vaccine within 28 days after the final study injection
- •Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (eg, infliximab), or blood products within 90 days prior to the Randomization Visit or plans to receive them during the study
- •Female participant with positive pregnancy test or Lactating females
- •Has positive serology tests result (HIV, HCV and HBsAg) at screening visit
- •Has positive drugs of abuse test results at screening visit
- •Has participated in an interventional clinical study within 3 months prior to the Randomization Visit or plans to do so while participating in this study
- •Has donated ≥450 mL of blood products within 28 days prior to the Randomization Visit or plans to donate blood products during the study
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo is a comparator to Study Vaccine
干预措施: Placebo (Other)
Part A: in healthy volunteers age ≥18 years and ≤ 54 years Part B: in healthy volunteers ≥55 year
Experimental
Part A: Three (3) APL-10456-Vaccine dose levels which will be a sequential cohort single dose-escalation are planned, Part B will be a parallel group randomized controlled study to evaluate a two dose, prime and boost regimen of APL-10456-Vaccine in 3 dose levels
干预措施: APL-10456-Vaccine (Drug)
结局指标
主要结局
To evaluate the safety and reactogenicity of APL-10456-Vaccine in healthy volunteers (HVs)
时间窗: Through Study Completion (Approx 365 days)
Collecting AEs in Part A: HVs from 18 to 54 years of age, inclusive and Part B: HVs ≥ 55 years of age. Incidence, severity, relationship and outcome of Adverse Events (AE)
次要结局
- To assess the immunogenicity of a single dose of APL-10456-Vaccine in Part A and B, and a prime/boost administration of APL-10456-Vaccine in Part B(Day 8 and Day 29 in Part A and approximately monthly visits up to Day 365 in Part B)
研究者
研究点 (2)
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