NCT04480736撤回2 期
A Phase 2a, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics of Repeated Oral Doses of JNJ-64281802 Against Dengue Serotype 1 Infection in a Dengue Human Challenge Model in Healthy Adult Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Area Under the DENV-1 RNA VL-concentration time Curve (VL AUC) from Immediately before Inoculation (Baseline on Day 1) until Day 29
研究概览
简要总结
The purpose of this study is to assess the antiviral activity of JNJ-64281802 versus placebo in terms of reduction of dengue virus 1 (DENV-1) ribonucleic acid (RNA) viral load (VL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically relevant. This determination must be recorded in the participant's source documents and initialed and dated by the investigator
- •Must pass the comprehension test (i.e., obtain a passing score of greater than or equal to (>=) 75 percent (%), with up to 3 attempts in total) indicating that he or she understands the purpose, procedures, and potential risks and benefits of the study, after reading the informed consent and after the investigator or designee has provided detailed information on the study and answered the potential participant's questions
- •Must have a blood pressure (after the participant is supine for >=5 minutes) between 90 and 140 millimeters of Mercury (mmHg) systolic, extremes included, and less than or equal to (<=) 90 mmHg diastolic at screening. Two repeat measurements are allowed in the absence of any other concerning health screening issues
- •Must have a Body mass index (BMI) (weight in kilogram divided by the square of height in meters) between 18.0 and 33.0 kilogram per meter square (kg/m^2), extremes included, and a body weight of >=50.0 kg at screening
- •All women of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin) pregnancy test at screening
排除标准
- •Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its excipients, to a previous vaccination, or to specific medications/animals for which antigens may be in the dengue virus (DENV)-1 challenge strain preparations, including shellfish, fetal bovine serum, L-glutamine, neomycin, and streptomycin
- •Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- •Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 6 months before first dose of study drug, or is currently enrolled in an investigational study, or is planning to be enrolled in an investigational study within 90 days after last dose of study drug
- •Pregnant, breastfeeding, or planning to become pregnant during the study or within 90 days after last dose of study drug
- •Plans to father a child during the study or within 90 days after last dose of study drug
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive matching placebo of JNJ-64281802 orally.
干预措施: Placebo (Drug)
JNJ-64281802 High dose
Experimental
Participants will receive high dose of JNJ-64281802 orally.
干预措施: JNJ-64281802 High dose (Drug)
JNJ-64281802 Medium dose
Experimental
Participants will receive medium dose of JNJ-64281802 orally.
干预措施: JNJ-64281802 Medium dose (Drug)
JNJ-64281802 Low dose
Experimental
Participants will receive low dose of JNJ-64281802 orally.
干预措施: JNJ-64281802 Low dose (Drug)
JNJ-64281802 Dosing Regimen X
Experimental
Participants will receive dosing regimen X of JNJ-64281802 orally.
干预措施: JNJ-64281802 Dosing Regimen X (Drug)
JNJ-64281802 Dosing Regimen Y
Experimental
Participants will receive dosing regimen Y of JNJ-64281802 orally.
干预措施: JNJ-64281802 Dosing Regimen Y (Drug)
JNJ-64281802 Dosing Regimen Z
Experimental
Participants will receive dosing regimen Z of JNJ-64281802 orally.
干预措施: JNJ-64281802 Dosing Regimen Z (Drug)
结局指标
主要结局
Area Under the DENV-1 RNA VL-concentration time Curve (VL AUC) from Immediately before Inoculation (Baseline on Day 1) until Day 29
时间窗: Baseline to Day 29
Area under the dengue virus (DENV)-1 ribonucleic acid (RNA) Viral Load (VL) concentration-time curves from immediately before inoculation (baseline on Day 1) until Day 29 will be reported.
次要结局
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability(Up to Day 85)
- Number of Participants with Clinically Significant Abnormalities in Physical Examination(Up to Day 85)
- Number of Participants with Clinically Significant Abnormalities in Vital Signs(Up to Day 85)
- Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs)(Up to Day 21)
- Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters(Up to Day 85)
- Number of Participants with DENV Infection Associated AEs(Up to Day 85)
- Area Under the log10-transformed DENV 1 RNA VL Concentration-time Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29(Baseline to Day 29)
- Peak of Detectable DENV-1 RNA(Up to Day 85)
- Duration of Detectable DENV-1 RNA(Up to Day 85)
- Time to First Onset of Detectable DENV-1 RNA(Up to Day 85)
- Number of Participants with Detectable DENV-1 RNA(Up to Day 85)
- Area Under the Viremia Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29(Baseline to Day 29)
- Area Under the log10-transformed Viremia Curves(Up to Day 85)
- Peak of Detectable Viremia Level(Up to Day 85)
- Duration of Detectable Viremia(Up to Day 85)
- Time to First Onset of Detectable Viremia(Up to Day 85)
- Number of Participants with Detectable Viremia(Up to Day 85)
- Maximum Observed Analyte Concentration (Cmax) of JNJ-64281802(Day -5: Predose, 1, 2, 4, 6, 8, 10, 12 hours Postdose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose)
- Minimum Observed Analyte Concentration (Cmin) of JNJ-64281802(Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose)
- Trough Plasma Analyte Concentration (Ctrough) of JNJ-64281802(Day -4, 1, 6, 8, 10, and 15: Predose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose)
- Average Analyte Concentration (Cavg) of JNJ-64281802(Day -5: Predose, 1, 2, 4, 6, 8, 10, 12 hours postdose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose)
- Time to Reach Maximum Observed Plasma Analyte Concentration (Tmax) of JNJ-64281802(Day -5: Predose, 1, 2, 4, 6, 8, 10, 12 hours postdose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose)
- Fluctuation Index (FI) of JNJ-64281802(Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose)
- Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau)(Day -5: Predose, 1, 2, 4, 6, 8, 10, 12 hours postdose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose)
- Number of Participants with Anti DENV-1 Total IgM and IgG Antibody Titers(Up to Day 85)
- Time to First Onset of Anti-DENV-1 Total IgM and IgG Antibody Titers(Up to Day 85)
研究者
研究点 (1)
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