Clinical trial NCT06864507: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Chronic Spontaneous Urticaria
Keywords: Chronic spontaneous urticaria
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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)

Primary outcomes:
measure: Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.(Phase 1)
timeFrame: SD：up to 7 days，MD：up to 35 days
measure: Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 (Phase 2)
timeFrame: Week 4
Secondary outcomes:
measure: Cmax
timeFrame: Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD)
measure: Tmax
timeFrame: Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD)
measure: AUC
timeFrame: Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD)
measure: t½
timeFrame: Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD)
measure: CL/F
timeFrame: Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD)
measure: Vd/F
timeFrame: Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD)
measure: Rac
timeFrame: Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD)
measure: Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.(Phase 2)
timeFrame: up to 16 weeks
measure: Change from baseline in Weekly Itch Severity Score (ISS7) at Week 12(Phase 2)
timeFrame: Week 12
measure: Change from baseline in Weekly Hives Severity Score (HSS7) at Week 12(Phase 2)
timeFrame: Week 12
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Hospital of Skin Disease
state: Shanghai
Study officials:
References: