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.
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)
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)
Parallel
HS-10561
DrugSingle and multiple doses of HS-10561 orally
Placebo
DrugPlacebo
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.(Phase 1)
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)
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.
Cmax
Maximum plasma concentration
Tmax
Time to reach Cmax
AUC
Area under the plasma concentration-time curve
t½
Terminal half-life
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