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Chronic Spontaneous UrticariaPhase 1/2NCT06864507

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.

A Phase 1/2 study testing HS-10561 in people with Chronic Spontaneous Urticaria, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Spontaneous Urticaria
What is being tested?
HS-10561
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteChina
Study dates
31 Mar 2025to 31 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Shanghai Hospital of Skin Disease

    Shanghai, Shanghai Municipality, 201203

Other trials in China

About this study

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.

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.

Being tested
HS-10561, Placebo
Keywords
Chronic spontaneous urticaria
Medical subject headings
Chronic Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-10561Drug

    Single and multiple doses of HS-10561 orally

  • PlaceboDrug

    Placebo

Study groups in NCT06864507
Study groupRoleWhat they receive
HS-10561 Dose 1ExperimentalHS-10561, Dose 1
Receives: Drug: HS-10561
HS-10561 Dose 2ExperimentalHS-10561, Dose 2
Receives: Drug: HS-10561
HS-10561 Dose 3ExperimentalHS-10561, Dose 3
Receives: Drug: HS-10561
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: SD：up to 7 days，MD：up to 35 days

  2. 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.

    Measured: Week 4

Secondary outcomes (10)

  1. Cmax

    Maximum plasma concentration

    Measured: Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD)

  2. Tmax

    Time to reach Cmax

    Measured: Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD)

  3. AUC

    Area under the plasma concentration-time curve

    Measured: Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD)

  4. t½

    Terminal half-life

    Measured: Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD)

  5. CL/F

    Apparent clearance

    Measured: Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD)

  6. Vd/F

    Apparent volume of distribution

    Measured: Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD)

  7. Rac

    Accumulation ratio

    Measured: Day 1 up to Day 4 (SD), Day 1 up to Day 35 (MD)

  8. Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.(Phase 2)

    Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation；Clinically significant changes in physical examination and anamnesis, vital signs, ECG, safety laboratory will be reported under (S)AEs.

    Measured: up to 16 weeks

  9. Change from baseline in Weekly Itch Severity Score (ISS7) at Week 12(Phase 2)

    The severity of the itch was recorded by the participant daily in their electronic Diary, on a scale of 0 (none) to 3 (severe). A weekly score (ISS7) was derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score was therefore 0 - 21 (highest itch severity).

    Measured: Week 12

  10. Change from baseline in Weekly Hives Severity Score (HSS7) at Week 12(Phase 2)

    The hives (wheals) severity score, defined by number of hives, was recorded by the participant daily in their electronic Diary, on a scale of 0 (none) to 3 (> 12 hives/12 hours). A weekly score (HSS7) was derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score was therefore 0 - 21 (highest hives activity).

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2025
  2. Study start31 Mar 2025 (estimated)
  3. Primary completion27 Sep 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06864507
Sponsor's protocol ID
HS-10561-101
Status last verified
Mar 2025
First submitted
4 Mar 2025
Last updated
7 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HS-10561 in people with Chronic Spontaneous Urticaria, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.(Phase 1) (time frame: SD：up to 7 days，MD：up to 35 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06864507.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.

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