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Chronic Spontaneous UrticariaEarly Phase 1NCT07686484

A Trial of HRS-3095 in Healthy Volunteers

A Early Phase 1 study testing HRS-3095 in people with Chronic Spontaneous Urticaria, run by Atridia Pty Ltd. at 1 site in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to assess safety, PK, Pharmacodynamic profile of a single dose of HRS-3095 in healthy participants 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteAustralia
Study dates
27 Jul 2026to 30 Oct 2026
Phase
Early Phase 1
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Main inclusion criteria

  1. Healthy white participants.
  2. Male or female aged between 18 years and 55 years (inclusive)
  3. Ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study.
  4. Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 19.0 and 30.0 kg/m2 (inclusive) at screening.
  5. Men and WOCBP must agree to take highly effective contraceptive methods

Main exclusion Criteria

  1. History or evidence of clinically significant disorders.
  2. Individuals with a history of drug allergies, specific allergies, or known history or suspected of being allergic to the study drug or same class drug or any component of it.
  3. Receipt of medical devices or another investigational drug within 3 months or 5 half-lives, whichever is longer prior to screening.
  4. History of excessive smoking in the past 1 month prior to screening
  5. History of illicit or prescription drug abuse or addiction within 1 year of screening, or positive urine drug screen at baseline.
  6. Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Veritus Research

    Bayswater, Victoria, 3153

Other trials in Australia

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of HRS-3095 in Healthy Participants

The purpose of this study is to assess safety, PK, Pharmacodynamic profile of a single dose of HRS-3095 in healthy participants

Being tested
HRS-3095
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-3095Drug

    Single dose HRS-3095 /placebo given orally - Dose level 1

  • HRS-3095Drug

    Single dose HRS-3095 /placebo given orally - Dose level 2

  • HRS-3095Drug

    Single dose HRS-3095 /placebo given orally - Dose level 3

Study groups in NCT07686484
Study groupRoleWhat they receive
HRS-3095 single dose Dose level 1ExperimentalSingle dose HRS-3095 /placebo given orally
Receives: Drug: HRS-3095
HRS-3095 single dose Dose level 2ExperimentalSingle dose HRS-3095 /placebo given orally
Receives: Drug: HRS-3095
HRS-3095 single dose Dose level 3ExperimentalSingle dose HRS-3095 /placebo given orally
Receives: Drug: HRS-3095

What is being measured

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

  1. Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events

    Number of participants with Adverse events and Serious adverse events

    Measured: Day 8

Secondary outcomes (5)

  1. PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - Cmax

    Maximum observed plasma concentration (Cmax)

    Measured: Day 4

  2. PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - AU0-inf

    Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC₀0-inf)

    Measured: Day 4

  3. PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - Tmax

    Time to reach maximum observed plasma concentration (Tmax)

    Measured: Day 4

  4. PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - t½

    Terminal elimination half-life (t1/2)

    Measured: Day 4

  5. PD Profile of HRS-3095 After a Single dose administration:

    Target occupancy assessment

    Measured: Day 8

Timeline

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

  1. First posted7 Jul 2026
  2. Study start27 Jul 2026
  3. Primary completion16 Oct 2026
  4. Study completion30 Oct 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
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
HRS-3095 or matching placebo given orally
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07686484
Sponsor's protocol ID
HRS-3095-102
Status last verified
Jun 2026
First submitted
22 Jun 2026
Last updated
30 Oct 2026
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 Early Phase 1 study testing HRS-3095 in people with Chronic Spontaneous Urticaria, run by Atridia Pty Ltd. at 1 site in Australia.

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

Who may be eligible to take part?

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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 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 Australia. 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. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events (time frame: Day 8). 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 NCT07686484.

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 30 Oct 2026.

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