A First-in-Human, Phase 1a, Randomized, Double-Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose and Food Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABS-1230 Administered Orally to Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Safety and tolerability (incidence, severity, and dose-relationship of adverse events)
研究概览
简要总结
This first in human trial will evaluate the safety, tolerability, and pharmacokinetics of single ascending doses, multiple ascending doses, and fed and fasted doses of ABS-1230 given orally compared with placebo in adult healthy participants.
详细描述
This is a Phase 1a, first-in-human, placebo-controlled study consisting of 3 parts.
Part 1 is a single ascending dose (SAD) study in up to 40 participants consisting of a screening period of up to 28 days prior to a single dose of ABS-1230 or placebo, with follow-up 7 days and 14 days after dosing.
Part 2 is a multiple ascending dose (MAD) study in up to 30 participants consisting of a screening period of up to 28 days, followed by ABS-1230 or placebo once daily for 14 days, with follow-up 7 days and 14 days after dosing is completed.
Part 3 is a food effect (FE) study in 12 participants consisting of two doses of ABS-1230 under fasted and fed conditions and in combination with omeprazole with follow-up 7 days and 14 days after dosing is completed.
Part 4 is a drug-drug interaction (DDI) study in 10 participants consisting of doses of ABS-1230 in combination with voriconazole, with follow-up 15 days after dosing is completed.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age 18 to 55 years, inclusive
- •Body mass index greater than or equal to 18 to less than or equal to 32 kg/m2
- •Medically healthy with no clinically significant medical history, physical examination, vital sign, standard 12-lead ECG, chemistry, hematology, urinalysis, or coagulation results at Screening as deemed by the Investigator
- •Male and female subjects must use adequate birth control and agree not to donate sperm or eggs for the time periods specified in the protocol
排除标准
- •Positive result for HIV, HBV, or HCV
- •History of malignancy other than treated basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix
- •History of alcoholism or recreational drug use within 2 years or a positive alcohol or tobacco test result at screening or first check-in visit
- •For female participants, must not be pregnant, breastfeeding, or seeking to become pregnant while in the study
研究组 & 干预措施
ABS-1230 Singe Dose + Voriconazole
Single doses of ABS-1230 + voriconazole
干预措施: ABS-1230 (Drug)
ABS-1230 Singe Dose + Voriconazole
Single doses of ABS-1230 + voriconazole
干预措施: Voriconazole (Drug)
Placebo Single Dose
Single doses of placebo
干预措施: Placebo (Drug)
Placebo Multiple Doses
Multiple doses of placebo
干预措施: Placebo (Drug)
ABS-1230 Multiple Doses
Multiple doses of ABS-1230
干预措施: ABS-1230 (Drug)
ABS-1230 Singe Dose + Omeprazole
Single doses of ABS-1230 + omeprazole
干预措施: Omeprazole (Drug)
ABS-1230 Single Dose
Single doses of ABS-1230
干预措施: ABS-1230 (Drug)
ABS-1230 Singe Dose + Omeprazole
Single doses of ABS-1230 + omeprazole
干预措施: ABS-1230 (Drug)
结局指标
主要结局
Safety and tolerability (incidence, severity, and dose-relationship of adverse events)
时间窗: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
To assess safety and tolerability of ABS-1230 following single and multiple oral administration by determining the incidence, severity, and dose-relationship of adverse events
Safety and tolerability (incidence, severity, and dose-relationship of clinically significant changes in laboratory parameters)
时间窗: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
To assess safety and tolerability of ABS-1230 following single and multiple oral administration by determining the incidence, severity, and dose-relationship of clinically significant laboratory changes
次要结局
- Maximum Plasma Concentration [AUCinf] After Single Dose of ABS-1230(Measured from Day 1 to End of Study or Early Termination (up to 2 weeks))
- Maximum Plasma Exposure [AUCtau] After Multiple Doses of ABS-1230(Measured from Day 1 to End of Study or Early Termination (up to 4 weeks))
- Maximum Plasma Exposure [AUCtau] After Fed, Fasted and in Combination with Omeprazole Doses of ABS-1230(Measured from Day 1 to End of Study or Early Termination (up to 4 weeks))
- Maximum Plasma Concentration [Cmax] of ABS-1230 in Combination with Voriconazole(Measured from Day 1 to End of Study or Early Termination (up to 4 weeks))
- Maximum Plasma Exposure [AUCtau] of ABS-1230 in Combination with Voriconazole(Measured from Day 1 to End of Study or Early Termination (up to 4 weeks))
- Maximum Plasma Concentration [Cmax] After Fed, Fasted and in Combination with Omeprazole Doses of ABS-1230(Measured from Day 1 to End of Study or Early Termination (up to 4 weeks))
- Maximum Plasma Concentration [Cmax] After Single Dose of ABS-1230(Measured from Day 1 to End of Study or Early Termination (up to 2 weeks))
- Maximum Plasma Concentration [AUCtau] After Single Dose of ABS-1230(Measured from Day 1 to End of Study or Early Termination (up to 2 weeks))
- Maximum Plasma Concentration [Cmax] After Multiple Doses of ABS-1230(Measured from Day 1 to End of Study or Early Termination (up to 4 weeks))
- Maximum Plasma Concentration [AUCtau] After Multiple Doses of ABS-1230(Measured from Day 1 to End of Study or Early Termination (up to 4 weeks))
- Maximum Plasma Concentration [AUCtau] After Fed, Fasted and in Combination with Omeprazole Doses of ABS-1230(Measured from Day 1 to End of Study or Early Termination (up to 4 weeks))