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 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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Spontaneous Urticaria
• Intervention / Treatment: Drug: HRS-3095 Tablet; Drug: HRS-3095 Placebo Tablet

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yifan Li; Phone Number: +86-0518-82342973; Email: yifan.li@hengrui.com
• Study Contact Backup: Name: Hongda Lin; Phone Number: +86-0518-82342973; Email: hongda.lin@hengrui.com

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266555
      • Recruiting
      • The Frist Clinical Medicial College of Qingdao University
      • Principal Investigator: Yu Cao
      • Contact: Yu Cao; Phone Number: +86-0532-82911767; Email: caoyu1767@126.com

Participation Criteria

Eligibility Criteria

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

Description

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:

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-3095 Group	Drug: HRS-3095 Tablet; Oral HRS-3095 tablet.
Placebo Comparator: HRS-3095 Placebo Group	Drug: HRS-3095 Placebo Tablet; Oral HRS-3095 placebo tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (AEs)	Up to 21 days.
Incidence of serious adverse events (SAEs)	Up to 21 days.

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum concentration (Cmax)	Up to 17 days.
Time of maximum concentration (Tmax)	Up to 17 days.
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last)	Up to 17 days.
Area under the concentration-time curve from time zero to infinity (AUC0-inf)	Up to 17 days.
Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau)	Up to 17 days.
Elimination half-life (t1/2)	Up to 17 days.
Apparent clearance (CL/F)	Up to 17 days.
Apparent volume of distribution (Vz/F)	Up to 17 days.

Collaborators and Investigators

• Sponsor: Chengdu Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Estimated): November 17, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

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-3095-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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