NCT05765955已完成1 期
A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, PK and the Immunosuppressive Effects of p38 MAPK Inhibitor POLB 001 on the Intradermal and Intravenous LPS Challenge Response 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
- 36
- 试验地点
- 1
- 主要终点
- Effect of intravenous LPS challenge
研究概览
简要总结
A single center trial to evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers aged 18 to 55 years, inclusive.
- •BMI in the range of 18 to 32 kg/m2 a minimum body weight of 50 kg.
- •Fitzpatrick skin type I-III.
- •Able to give written informed consent and willing to comply with all study-related procedures.
- •Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
排除标准
- •(A history of) any clinically significant medical condition or abnormalities, as judged by the investigator.
- •History of sepsis, cardiovascular disease or malignancy.
- •History of trauma with likely damage to the spleen or surgery to spleen.
- •History of alcohol or drug abuse.
- •Any clinically significant febrile illness 30 days preceding study Day
- •History of serious bleeding.
- •Clinical evidence of significant or unstable medical illness including neurological, hematological, cardiovascular (including clinically significant arrhythmia), hepatic, pulmonary, metabolic, gastrointestinal, renal, psychiatric, endocrine, or infectious diseases or malignancies. Subjects who have had splenectomy.
- •Previous participation in a systemic (i.v./inhaled) LPS challenge trial within a year before the first study day.
- •Have any current and / or recurrent pathologically, clinically significant skin condition at the lower forearms (i.e., atopic dermatitis) including tattoos.
- •Antibiotic use, operation or intervention by surgeon/dentist within one month before the first study day.
- •Subjects who have used any prescribed or non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration, or less than 5 half-lives (whichever is longer), and during the study (except for vitamin/mineral supplements) unless, in the opinion of the Investigator, the medication will not interfere with the study procedures or compromise safety.
- •Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration unless, in the opinion of the Investigator, the medication will not interfere with the study procedures or compromise safety.
- •Any active inflammatory or infectious disease (e.g., periodontitis).
- •Known immunodeficiency.
- •Positive test results for Hepatitis B, Hepatitis C, HIV antibody.
- •Subjects who consume on average more than 3 units of alcohol per day (one alcohol unit =1 beer [12 oz] =1 wine [5 oz] =1 spirits [1.5 oz]) or are unable to abstain from using alcohol during the study
研究组 & 干预措施
POLB 001 30 mg
Active Comparator
干预措施: POLB 001 (Drug)
POLB 001 70 mg
Active Comparator
干预措施: POLB 001 (Drug)
POLB 001 150 mg
Active Comparator
干预措施: POLB 001 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of intravenous LPS challenge
时间窗: 16 days
To evaluate the effect of POLB 001 on inflammatory responses following an intravenous LPS challenge in healthy volunteers Endpoints: Blood - Cytokines (IL-6, IL-8, IL-10, TNF, IL-1β) (pg/mL)
Effect of intradermal LPS challenge
时间窗: 16 days
To evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers Endpoints: Blister exudate analysis - Cytokines (IL-6, IL-8, TNF, IL-1β) (pg/mL)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Assess the Pharmacokinetics, Immunogenicity and Safety of Escalating Doses of BMS-188667 Given as a Single Intravenous Infusion to Patients With Psoriasis VulgarisPsoriasis VulgarisNCT00277225Bristol-Myers Squibb32
已完成
1 期
Study Evaluating the Effects of PSI-697 on Platelets in Subjects Who SmokeHealthyNCT03860506Pfizer30
已完成
1 期
Safety and Immunogenicity Study of tgAAC09, a Gag-PR-RT AAV HIV VaccineHIV InfectionNCT00482027International AIDS Vaccine Initiative80
Unknown
1 期
Safety and Immunogenicity of High-dose IN-B001 in Healthy SubjectsHand, Foot and Mouth DiseaseNCT04637919HK inno.N Corporation30
终止
1 期
Induction of Immune-mediated aBscOpal Effect thrOugh STEreotactic Radiation Therapy in Metastatic Melanoma Patients Treated by PD-1 + CTLA-4 Inhibitors (BOOSTER MELANOMA)MelanomaNCT03354962Institut Claudius Regaud6