A Randomized, Double-blind, Placebo-controlled Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HS-10561 Capsule in Healthy Chinese Adults and Patients With Chronic Spontaneous Urticaria.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.(Phase 1)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HS-10561 capsule in healthy Chinese adults and patients with chronic spontaneous urticaria.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent must be obtained before any assessment is performed.(SD)
- •Healthy adults aged 18-45 years (inclusive) at the time of signing the informed consent form;(SD)
- •Male participants weighing ≥ 50 kg and female participants weighing ≥ 40 kg; body mass index (weight/square of height (kg/m2)) within the range of 18-30 kg/m2 (inclusive);(SD)
- •Female participants and male participants (including their female partners) agree to use highly effective methods of contraception from the date of signing the informed consent form until 30 days after the last dose;(SD)
- •Without history of severe respiratory, gastrointestinal (such as inflammatory bowel disease, Crohn's disease, chronic diarrhea, etc.), neurological, circulatory, urinary, endocrine, musculoskeletal, immune system disorders, or a history of tumors prior to screening.(SD)
- •Written informed consent must be obtained before any assessment is performed.(MD and Phase 2)
- •Healthy adults aged 18-65 years (inclusive) at the time of signing the informed consent form;(MD and Phase 2)
- •Have been diagnosed with chronic spontaneous urticaria for ≥6 months at the time of screening;(MD and Phase 2)
- •Female participants and male participants (including their female partners) agree to use highly effective methods of contraception from the date of signing the informed consent form until 30 days after the last dose.(MD and Phase 2)
排除标准
- •Have clinically significant abnormalities in vital signs, physical examination, laboratory tests, chest X-ray/CT, or abdominal ultrasound during the screening period, which, as assessed by the investigator, may increase the participants' risk or affect the scientific validity of the study;(SD)
- •Females with a positive blood pregnancy test, breastfeeding females, or participants planning to become pregnant during the study period;(SD)
- •Any physiological or psychological condition or disease, as determined by the investigator, that could increase the risk, affect the participants' compliance, or impact the participants' ability to complete the study.(SD)
- •Chronic urticaria with a clear primary or sole trigger (chronic inducible urticaria);(MD and Phase 2)
- •Clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria);(MD and Phase 2)
- •Other diseases with symptoms of urticaria or angioedema;(MD and Phase 2)
- •Other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results;(MD and Phase 2)
- •Pregnant or nursing (lactating) women.(MD and Phase 2)
研究组 & 干预措施
HS-10561 Dose 1
HS-10561, Dose 1
干预措施: HS-10561 (Drug)
HS-10561 Dose 2
HS-10561, Dose 2
干预措施: HS-10561 (Drug)
HS-10561 Dose 3
HS-10561, Dose 3
干预措施: HS-10561 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.(Phase 1)
时间窗: SD：up to 7 days，MD：up to 35 days
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.
Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 (Phase 2)
时间窗: Week 4
The Weekly Urticaria Activity Score (UAS7) is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42 (highest urticaria severity), and a minimum possible score of 0.
次要结局
- Cmax(Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD))
- Tmax(Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD))
- AUC(Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD))
- t½(Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD))
- CL/F(Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD))
- Vd/F(Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD))
- Rac(Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD))
- Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.(Phase 2)(up to 16 weeks)
- Change from baseline in Weekly Itch Severity Score (ISS7) at Week 12(Phase 2)(Week 12)
- Change from baseline in Weekly Hives Severity Score (HSS7) at Week 12(Phase 2)(Week 12)