A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety of AT-752 in Patients With Dengue Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in Dengue (DENV) Viral Load From Baseline
研究概览
简要总结
The Phase 2 study will be conducted in adult patients with confirmed Dengue infection and will investigate safety, PK, and pharmacodynamics (PD) in this population. The study will be conducted in several dosing cohorts to enable dose selection for subsequent trials
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Eligible subjects will be randomized to receive either AT-752 or matching placebo orally 3 times a day (TID) for 5 days in Cohort 1 of the study.
Subsequent cohorts will receive AT-752/placebo either twice a day (BID) or TID
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-55 years of age at time of screening
- •Fever ≥38°C (or feeling feverish) with onset during the previous 48 hours
- •Live/work in or recent travel to dengue endemic area
- •Positive test confirming Dengue (DENV) on a NS1 antigen test or reverse transcription-polymerase chain reaction (RT-PCR) assay
- •Negative rapid diagnostic test result for Coronavirus (SARS-CoV-2) and Influenza A and B
排除标准
- •Pregnant, plans to become pregnant within 90 days of screening, or breast feeding.
- •Has previously received any investigational or approved vaccine for dengue
- •Previous history of HIV, chronic hepatitis B infection, or current hepatitis C infection (from medical history)
- •Use of any antiviral drug within 30 days or within 5 half-lives of the active drug or metabolite (for long-acting antivirals)
- •Current use of anticoagulant or antiplatelet drugs or documented medical history of bleeding disorders
- •Current use of medications for treatment of inflammatory bowel disease or documented medical history of chronic gastrointestinal disease including inflammatory bowel disease
- •Immunocompromised due to use of immunosuppressive drugs including systemic corticosteroids (inhaled or topical corticosteroids are allowed) or any current disease or condition
- •Evidence of severe dengue disease
- •Confirmed or suspected Coronavirus (SARS-CoV-2) infection or contact with patients with confirmed SARS-CoV2 infection within 7 days prior to screening
- •Other clinically significant medical conditions or laboratory abnormalities, as described in the protocol.
研究组 & 干预措施
AT-752 750-mg TID for 5 days
Tablet; 750-mg, Three (3) times a day for 5-days
干预措施: AT-752 (Drug)
AT-752 750-mg TID for 5 days
Tablet; 750-mg, Three (3) times a day for 5-days
干预措施: Placebo (Drug)
AT-752 Dose A for 5 days
Tablet; Dose A, for 5-days
干预措施: AT-752 (Drug)
AT-752 Dose A for 5 days
Tablet; Dose A, for 5-days
干预措施: Placebo (Drug)
AT-752 Dose B for 5 days
Tablet; Dose B, for 5-days
干预措施: AT-752 (Drug)
AT-752 Dose B for 5 days
Tablet; Dose B, for 5-days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Dengue (DENV) Viral Load From Baseline
时间窗: Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 14, Day 28
To investigate the antiviral activity of AT-752 versus placebo in terms of reduction of DENV RNA from baseline in adult subjects with confirmed DENV infection
次要结局
- Pharmacokinetic (PK) Endpoint(Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose)