A Trial of HRS-3095 in Healthy Volunteers

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Spontaneous Urticaria
• Intervention / Treatment: Drug: HRS-3095; Drug: HRS-3095; Drug: HRS-3095

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Kathy You; Phone Number: +61 02 9299 0433; Email: kathyyou@atridia.com
• Study Contact Backup: Name: Eimy Minowa; Phone Number: +61 432223162; Email: eimy.minowa@atridia.com

Study Locations

• Australia
  • Victoria
    • Bayswater, Victoria, Australia, 3153
      • Veritus Research
      • Contact: Emir Redzepagic, Dr; Phone Number: +61 3 8736 1750; Email: info@veritusresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-3095 single dose Dose level 1; Single dose HRS-3095 /placebo given orally	Drug: HRS-3095; Single dose HRS-3095 /placebo given orally - Dose level 1; Drug: HRS-3095; Single dose HRS-3095 /placebo given orally - Dose level 2; Drug: HRS-3095; Single dose HRS-3095 /placebo given orally - Dose level 3
Experimental: HRS-3095 single dose Dose level 2; Single dose HRS-3095 /placebo given orally	Drug: HRS-3095; Single dose HRS-3095 /placebo given orally - Dose level 1; Drug: HRS-3095; Single dose HRS-3095 /placebo given orally - Dose level 2; Drug: HRS-3095; Single dose HRS-3095 /placebo given orally - Dose level 3
Experimental: HRS-3095 single dose Dose level 3; Single dose HRS-3095 /placebo given orally	Drug: HRS-3095; Single dose HRS-3095 /placebo given orally - Dose level 1; Drug: HRS-3095; Single dose HRS-3095 /placebo given orally - Dose level 2; Drug: HRS-3095; Single dose HRS-3095 /placebo given orally - Dose level 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - Cmax	Maximum observed plasma concentration (Cmax)	Day 4
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)	Day 4
PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - Tmax	Time to reach maximum observed plasma concentration (Tmax)	Day 4
PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - t½	Terminal elimination half-life (t1/2)	Day 4
PD Profile of HRS-3095 After a Single dose administration:	Target occupancy assessment	Day 8

Collaborators and Investigators

• Sponsor: Atridia Pty Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Urticaria; Skin Diseases, Vascular; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Chronic Urticaria
• Other Study ID Numbers: HRS-3095-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No