A Trial of HRS-3095 in Healthy Volunteers

NCT07686484 | Not Yet Recruiting Early Phase 1

• 1 other identifier: HRS-3095-102
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Spontaneous Urticaria

Outcome Measures

Primary Outcomes (1)

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

  Number of participants with Adverse events and Serious adverse events

  Day 8

Secondary Outcomes (5)

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

  Day 4

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

  Day 4

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

  Day 4

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

  Day 4

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

  Day 8

Study Arms (3)

HRS-3095 single dose Dose level 1

EXPERIMENTAL

Single dose HRS-3095 /placebo given orally

Drug: HRS-3095

HRS-3095 single dose Dose level 2

EXPERIMENTAL

Single dose HRS-3095 /placebo given orally

Drug: HRS-3095

HRS-3095 single dose Dose level 3

EXPERIMENTAL

Single dose HRS-3095 /placebo given orally

Drug: HRS-3095

Interventions

HRS-3095 DRUG

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

HRS-3095 single dose Dose level 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy white participants.
• Male or female aged between 18 years and 55 years (inclusive)
• 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.
• 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.
• Men and WOCBP must agree to take highly effective contraceptive methods

You may not qualify if:

• History or evidence of clinically significant disorders.
• 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.
• Receipt of medical devices or another investigational drug within 3 months or 5 half-lives, whichever is longer prior to screening.
• History of excessive smoking in the past 1 month prior to screening
• History of illicit or prescription drug abuse or addiction within 1 year of screening, or positive urine drug screen at baseline.
• 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.

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (1)

Veritus Research

Bayswater, Victoria, 3153, Australia

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

Central Study Contacts

Kathy You

CONTACT

+61 02 9299 0433; kathyyou@atridia.com

Eimy Minowa

CONTACT

+61 432223162; eimy.minowa@atridia.com

Study Design

• Study Type: interventional
• Phase: early 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

Model Details: HRS-3095 or matching placebo given orally

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 7, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-06

Locations

AU (1)