A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HS-10561 Capsule in Healthy Chinese Adults and Patients With Chronic Spontaneous Urticaria.

Launched by JIANGSU HANSOH PHARMACEUTICAL CO., LTD. · Mar 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called HS-10561, used to see if it is safe and effective for treating chronic spontaneous urticaria (CSU), a condition that causes itchy hives without a clear reason. The trial will involve healthy adults and patients with CSU, and it is designed to gather information about how the drug behaves in the body and how well it works. The study will be conducted in a double-blind manner, meaning that neither the participants nor the researchers will know who receives the actual medication and who receives a placebo (a look-alike pill with no active ingredients) to ensure unbiased results.

To be eligible for this trial, participants must be healthy adults aged 18 to 65 years who have signed consent forms. For those with CSU, they should have had the condition for at least six months. Key factors include being of a certain weight and body mass index, and both male and female participants must agree to use effective birth control during the study. Participants can expect to undergo health assessments and will be monitored closely throughout the trial to ensure their safety. The study is not yet recruiting participants, but it aims to provide valuable insights into a potential new treatment for CSU.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• Exclusion Criteria:
• • 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)