Chronic Spontaneous UrticariaPhase 1NCT07230418
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 study testing HRS-3095 Tablet in people with Chronic Spontaneous Urticaria, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- HRS-3095 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2025to 19 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to comprehend and willing to sign an informed consent form (ICF);
- Male and female healthy subjects with an age range between 18 and 55 years (inclusive);
- 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;
- For healthy subjects, no clinically significant abnormalities;
- Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods.
Who cannot join
- 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;
- Any condition or disease that may affect drug absorption, distribution, metabolism, or excretion, as determined by the Investigator;
- History of recurrent drug allergies, or a physician-diagnosed and treatment-requiring allergic disease, or known allergy to any component of the investigational product;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Frist Clinical Medicial College of Qingdao University
Qingdao, Shandong, 266555
About this study
Official title: A Double-blind, Randomized, Dose-escalation Phase I Clinical Trial 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
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.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- HRS-3095 Tablet, HRS-3095 Placebo Tablet
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-3095 TabletDrug
Oral HRS-3095 tablet.
HRS-3095 Placebo TabletDrug
Oral HRS-3095 placebo tablet.
| Study group | Role | What they receive |
|---|---|---|
| HRS-3095 Group | Experimental | Not described Receives: Drug: HRS-3095 Tablet |
| HRS-3095 Placebo Group | Placebo comparator | Not described Receives: Drug: HRS-3095 Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: Up to 21 days.
Incidence of serious adverse events (SAEs)
Measured: Up to 21 days.
Secondary outcomes (8)
Maximum concentration (Cmax)
Measured: Up to 17 days.
Time of maximum concentration (Tmax)
Measured: Up to 17 days.
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last)
Measured: Up to 17 days.
Area under the concentration-time curve from time zero to infinity (AUC0-inf)
Measured: Up to 17 days.
Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau)
Measured: Up to 17 days.
Elimination half-life (t1/2)
Measured: Up to 17 days.
Apparent clearance (CL/F)
Measured: Up to 17 days.
Apparent volume of distribution (Vz/F)
Measured: Up to 17 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start10 Nov 2025
- Primary completion19 Apr 2026
- Study completion19 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230418
- Sponsor's protocol ID
- HRS-3095-101
- Status last verified
- Jun 2026
- First submitted
- 13 Nov 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Dose-escalation Phase I Clinical Trial 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
- ClinicalTrials.gov ID
- NCT07230418
- Acronym / sponsor ID
- HRS-3095-101
- Conditions
- Chronic Spontaneous Urticaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 19 Apr 2026 (actual)
- Study completion
- 19 Apr 2026 (actual)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-3095 Group | Experimental | Drug: HRS-3095 Tablet |
| HRS-3095 Placebo Group | Placebo comparator | Drug: HRS-3095 Placebo Tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able to comprehend and willing to sign an informed consent form (ICF);
- Male and female healthy subjects with an age range between 18 and 55 years (inclusive);
- 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;
- For healthy subjects, no clinically significant abnormalities;
- Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods.
Key exclusion criteria (4 listed)
- 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;
- Any condition or disease that may affect drug absorption, distribution, metabolism, or excretion, as determined by the Investigator;
- History of recurrent drug allergies, or a physician-diagnosed and treatment-requiring allergic disease, or known allergy to any component of the investigational product;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-3095 TabletOral HRS-3095 tablet. | Drug | HRS-3095 Group |
| HRS-3095 Placebo TabletOral HRS-3095 placebo tablet. | Drug | HRS-3095 Placebo Group |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Up to 21 days.
Incidence of serious adverse events (SAEs)
Time frame: Up to 21 days.
8 secondary outcomes
Maximum concentration (Cmax)
Time frame: Up to 17 days.
Time of maximum concentration (Tmax)
Time frame: Up to 17 days.
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.
Area under the concentration-time curve from time zero to infinity (AUC0-inf)
Time frame: Up to 17 days.
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.
Elimination half-life (t1/2)
Time frame: Up to 17 days.
Apparent clearance (CL/F)
Time frame: Up to 17 days.
Apparent volume of distribution (Vz/F)
Time frame: Up to 17 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-3095 Tablet in people with Chronic Spontaneous Urticaria, run by Chengdu Suncadia Medicine 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 12 Jun 2026. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of adverse events (AEs) (time frame: Up to 21 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?
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 12 Jun 2026.