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.

NCT06864507 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-10561-101
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Spontaneous Urticaria

Keywords

Chronic spontaneous urticaria

Outcome Measures

Primary Outcomes (2)

• 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.

  SD：up to 7 days，MD：up to 35 days

• 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.

  Week 4

Secondary Outcomes (10)

• 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)

Study Arms (4)

HS-10561 Dose 1

EXPERIMENTAL

HS-10561, Dose 1

Drug: HS-10561

HS-10561 Dose 2

EXPERIMENTAL

HS-10561, Dose 2

Drug: HS-10561

HS-10561 Dose 3

EXPERIMENTAL

HS-10561, Dose 3

Drug: HS-10561

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

HS-10561 DRUG

Single and multiple doses of HS-10561 orally

HS-10561 Dose 1; HS-10561 Dose 2; HS-10561 Dose 3

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Hospital of Skin Disease

Shanghai, Shanghai Municipality, 201203, China

Location

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 7, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): September 27, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

CN (1)