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

NCT07230418 | Recruiting Phase 1

• 1 other identifier: HRS-3095-101
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Spontaneous Urticaria

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events (AEs)

  Up to 21 days.

• Incidence of serious adverse events (SAEs)

  Up to 21 days.

Secondary Outcomes (8)

• 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.

Study Arms (2)

HRS-3095 Group

EXPERIMENTAL

Drug: HRS-3095 Tablet

HRS-3095 Placebo Group

PLACEBO COMPARATOR

Drug: HRS-3095 Placebo Tablet

Interventions

HRS-3095 Tablet DRUG

Oral HRS-3095 tablet.

HRS-3095 Group

HRS-3095 Placebo Tablet DRUG

Oral HRS-3095 placebo tablet.

HRS-3095 Placebo Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

The Frist Clinical Medicial College of Qingdao University

Qingdao, Shandong, 266555, China

RECRUITING

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

Hongda Lin

CONTACT

+86-0518-82342973; hongda.lin@hengrui.com

Yifan Li

CONTACT

+86-0518-82342973; yifan.li@hengrui.com

Study Design

• Study Type: interventional
• Phase: 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

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: November 10, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Locations

CN (1)