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CompletedNCT07230418Updated Jun 12, 2026

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of HRS-3095 Oral Administration in Healthy Subjects, as Well as the Effect of HRS-3095 on CYP3A4 Metabolic Enzymes

A Phase 1 interventional study of HRS-3095 Tablet and HRS-3095 Placebo Tablet in Chronic Spontaneous Urticaria, sponsored by Chengdu Suncadia Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Chengdu Suncadia Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
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Study summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS-3095 oral administration in healthy subjects. This study will also explore food effect and the effect of HRS-3095 on CYP3A4 metabolic enzymes.

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Conditions studied

  • Chronic Spontaneous Urticaria

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03

In context

Chronic Urticaria

214 studies on the registry are indexed under Chronic Urticaria; 47 are open to participants now.

This study's enrollment of 82 is close to the median of 83 across 164 interventional studies indexed under Chronic Urticaria.

Browse Chronic Urticaria studies →

Lead sponsor

Chengdu Suncadia Medicine Co., Ltd. is the lead sponsor of 22 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Able to comprehend and willing to sign an informed consent form (ICF);
  2. Male and female healthy subjects with an age range between 18 and 55 years (inclusive);
  3. Body mass index between 18.0 and 32.0 kg/m2 (inclusive), and the body weight is ≥ 50 kg for men and ≥ 45 kg for women;
  4. For healthy subjects, no clinically significant abnormalities;
  5. Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods.

Exclusion criteria

Exclusion Criteria:

  1. Known medical history or clinical manifestation of circulatory, endocrine, neurological, digestive, respiratory, hematological, immunological, psychiatric diseases, metabolic disorders, or any other condition that may interfere with the trial results, as determined by the Investigator;
  2. Any condition or disease that may affect drug absorption, distribution, metabolism, or excretion, as determined by the Investigator;
  3. History of recurrent drug allergies, or a physician-diagnosed and treatment-requiring allergic disease, or known allergy to any component of the investigational product;
  4. History of an infection requiring systemic antimicrobial therapy within 2 weeks prior to screening or within 2 weeks before the first dose of the investigational product.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    HRS-3095 Group

    Drug: HRS-3095 Tablet

  • Placebo comparator
    HRS-3095 Placebo Group

    Drug: HRS-3095 Placebo Tablet

Interventions

  • DrugHRS-3095 Tablet

    Oral HRS-3095 tablet.

  • DrugHRS-3095 Placebo Tablet

    Oral HRS-3095 placebo tablet.

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What researchers measure

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to 21 days.

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to 21 days.

Secondary outcomes

  1. Maximum concentration (Cmax)

    Time frame: Up to 17 days.

  2. Time of maximum concentration (Tmax)

    Time frame: Up to 17 days.

  3. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last)

    Time frame: Up to 17 days.

  4. Area under the concentration-time curve from time zero to infinity (AUC0-inf)

    Time frame: Up to 17 days.

  5. Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau)

    Time frame: Up to 17 days.

  6. Elimination half-life (t1/2)

    Time frame: Up to 17 days.

  7. Apparent clearance (CL/F)

    Time frame: Up to 17 days.

  8. Apparent volume of distribution (Vz/F)

    Time frame: Up to 17 days.

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Study locations

1 site
  • The Frist Clinical Medicial College of Qingdao University
    Qingdao, Shandong 266555, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07230418
Lead sponsor
Chengdu Suncadia Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Nov 17, 2025
Start date
Nov 10, 2025
Primary completion
Apr 19, 2026
Completion
Apr 19, 2026
Last update
Jun 12, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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