NCT04894071已完成1 期
A Phase 1, Randomized, Double-Masked, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral QA102 in Healthy Young and Older Adult Subjects
Smilebiotek Zhuhai Limited1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2021年5月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Incidence and severity of Adverse Events
研究概览
简要总结
This will be a double masked, randomized, placebo controlled, single and multiple oral dose study conducted in 3 parts. The safety and tolerability of single and multiple ascending oral doses of QA102 in healthy young and older adult subjects will be evaluated. The study will also characterize the pharmacokinetic (PK) profile of QA102 in plasma and urine after single and multiple oral doses of QA102. Besides, the metabolite profile of QA102 will also be characterized.
Part 1 will comprise a single dose, sequential cohort design. Part 2 will comprise a multiple dose, sequential cohort study. Part 3 will comprise a multiple dose, single cohort study in older subjects.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- •In good health, determined by no clinically significant findings from medical history, physical examination, visual acuity testing, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations at screening and check in as assessed by the investigator or designee.
- •Females of nonchildbearing potential defined as permanently sterile or postmenopausal. Males will agree to use contraception.
- •Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- •Young (between 18 and 59 years of age, for Part 1 and 2) or Older (between 60 and 75 years of age, for Part 3) males or females of nonchildbearing potential, of any race, inclusive, at screening.
排除标准
- •Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- •Active or recent (within 30 days of screening) infection or history of recurrent chronic infections with underlying condition that may predispose one to infections. Viral infections with symptoms resolved will be allowed up to 14 days prior to check-in.
- •History of malignancy of any type, other than surgically excised non-melanomatous skin cancers or in situ cervical cancer within 5 years before check-in.
- •Female subjects (surgically sterile females only) with a positive pregnancy test at screening or check in or who are lactating.
- •History of alcoholism or drug/chemical abuse within 2 years prior to check in.
- •Positive urine drug or alcohol results at screening or check in.
- •Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (whichever is longer) prior to dosing.
- •Consumption of alcohol from 48 hours prior to check-in.
- •Administration of any vaccine, including a Coronavirus Disease 2019 vaccine, within the past 30 days prior to dosing.
- •Subjects who, in the opinion of the investigator (or designee), should not participate in this study.
研究组 & 干预措施
QA102 group
Experimental
干预措施: QA102 (Drug)
Placebo group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of Adverse Events
时间窗: Up to 7 days after dosing
To evaluate the safety and tolerability of single and multiple ascending oral doses of QA102 in healthy young adult and elderly subjects.
次要结局
- Area under the plasma concentration-time curve (AUC) from time zero to 12 hours postdose [AUC0-12](up to 12 hours postdose)
- Maximum observed plasma concentration [Cmax](Up to 48 hours postdose)
- time of the maximum observed plasma concentration [tmax](up to 48 hours postdose)
研究者
研究点 (1)
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