A Placebo-Controlled, Blinded, Dose-Escalation, Study to Assess the Safety and Pharmacodynamics of Single and Multiple Doses of QBKPN (Inactivated Klebsiella Pneumoniae) Site Specific Immunomodulator (SSI), Administered Subcutaneously to Healthy Male and Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Incidence of Treatment-Emergent Adverse events [Safety and Tolerability]
研究概览
简要总结
The purpose of this dose-escalation study is to assess the safety and pharmacodynamics of single and multiple doses of QBKPN SSI, administered subcutaneously to healthy adult volunteers
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, non-smoking (at least for 6 months prior to first study drug administration) males or females, 18 to 65 years of age, inclusive at the time of informed consent.
- •Body mass index (BMI) that is within 18.5 - 30.0 kg/m2, inclusive.
- •Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination
- •Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 50-100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
- •QTc interval ≤ 450 milliseconds for males and females, unless deemed otherwise Not Clinically Significant by the Principal Investigator/Sub-Investigator.
- •Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
- •Agree not to have a tattoo or body piercing until the end of the study.
- •Agree to practice effective methods of contraception
排除标准
- •Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
- •A known history or positive test result for human immunodeficiency virus (HIV), chronic Hepatitis B surface antigen, or Hepatitis C.
- •A positive test result for drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), alcohol test and cotinine. Positive pregnancy test for female subjects.
- •Known history or presence of (1) Alcohol abuse or dependence within one year prior to first study drug administration; (2) Drug abuse or dependence; (3) Known or suspected hypersensitivity to any component of the product (4) Food allergies and/or presence of any dietary restrictions; or (5) Severe allergic reactions (e.g. anaphylactic reactions, angioedema).
- •Recent history (within 8 weeks prior to screening) of travel to or emigration from any country with high incidence for tuberculosis.
- •A positive tuberculin skin (PPD) test result
研究组 & 干预措施
SAD Cohort 3
Single dose of 0.20 mL QBKPN or Placebo
干预措施: QBKPN (Biological)
SAD Cohort 1
Single dose of 0.05 mL QBKPN or Placebo
干预措施: QBKPN (Biological)
MAD Cohort 1
5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort)
干预措施: QBKPN (Biological)
SAD Cohort 2
Single dose of 0.10 mL QBKPN or Placebo
干预措施: QBKPN (Biological)
MAD Cohort 4
5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort)
干预措施: QBKPN (Biological)
SAD Cohort 5
Single dose of 0.80 mL QBKPN or Placebo
干预措施: QBKPN (Biological)
SAD Cohort 6
Single dose of 1.2 mL QBKPN or Placebo
干预措施: QBKPN (Biological)
MAD Cohort 3
5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort)
干预措施: QBKPN (Biological)
MAD Cohort 2
5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort)
干预措施: Placebo (Other)
MAD Cohort 3
5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort)
干预措施: Placebo (Other)
SAD Cohort 1
Single dose of 0.05 mL QBKPN or Placebo
干预措施: Placebo (Other)
SAD Cohort 2
Single dose of 0.10 mL QBKPN or Placebo
干预措施: Placebo (Other)
SAD Cohort 3
Single dose of 0.20 mL QBKPN or Placebo
干预措施: Placebo (Other)
SAD Cohort 4
Single dose of 0.40 mL QBKPN or Placebo
干预措施: Placebo (Other)
SAD Cohort 5
Single dose of 0.80 mL QBKPN or Placebo
干预措施: Placebo (Other)
SAD Cohort 6
Single dose of 1.2 mL QBKPN or Placebo
干预措施: Placebo (Other)
MAD Cohort 1
5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort)
干预措施: Placebo (Other)
MAD Cohort 4
5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort)
干预措施: Placebo (Other)
SAD Cohort 4
Single dose of 0.40 mL QBKPN or Placebo
干预措施: QBKPN (Biological)
MAD Cohort 2
5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort)
干预措施: QBKPN (Biological)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse events [Safety and Tolerability]
时间窗: 2 weeks
Incidence, severity, and dose-relationship of adverse events, vital signs, and clinical laboratory parameters
次要结局
- Immunological biomarkers analysis(2 weeks)
- Changes in cellular biomarkers over time(2 weeks)