NCT05458076Unknown1 期
A Phase 1, Randomized, Double-blind, Single-and Multiple-dose Escalation, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QLS1128 and in Combination With Ritonavir in Healthy Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- The Adverse events of QLS1128
研究概览
简要总结
A study to evaluate safety, tolerability and pharmacokinetics of QLS1128 sustained-release tablets and in combination with ritonavir tablets in healthy participants
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects between ages of 18-45 years.
- •Male subjects' weight ≥ 50 kg, female subjects' weight ≥ 45 kg; body mass index ≥ 19 kg/m2 and ≤ 27 kg/m
- •Female participants of child-bearing potential/ Male subjects had fertile female partners must agree to use effective contraception from screening until 30 days after last dose.
排除标准
- •Participant who have a past history of COVID-19 infection or are currently showing symptoms of COVID-19 infection.
- •Participant who have been treated with any SARS-COV-2 neutralizing antibody or participated in clinical trials related to SARS-COV-2 (e.g., SARS-COV-2 neutralizing antibody, oral drug clinical trials, etc.).
- •Participant who tested positive for SARS-COV-2 nucleic acid during the screening period, or who were positive for COVID-19 antibody if not vaccinated against COVID-
- •Participant who have a clear history of allergy to drugs, food or pollen, or are allergic to ritonavir tablets and QLS1128 sustained-release tablets.
- •Any clinical serious disease of cardiovascular, endocrine, neurological, digestive, respiratory, hematological, metabolic, psychiatric or other systems determined by the investigator may interfere with the results of this clinical trial.
研究组 & 干预措施
QLS1128 A-Dose 1~5
Experimental
single dose
干预措施: QLS1128 A-Dose 1~5 and Ritonavir (Drug)
QLS1128 C-Dose 1~3
Experimental
Twice daily for 7 days
干预措施: QLS1128 C-Dose 1~3 and Ritonavir (Drug)
QLS1128 D-Dose 1
Experimental
fasting，high fat meal
干预措施: QLS1128 D-Dose 1 and Ritonavir (Drug)
结局指标
主要结局
The Adverse events of QLS1128
时间窗: Day 1 to Day 28
Adverse events, including type, incidence, grade (determined with reference to NCI-CTCAE V5.0)
次要结局
- The PK parameters of QLS1128(Day 1 to Day 3)
研究者
研究点 (1)
Loading locations...
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