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Completed

NCT Number: NCT07230418

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Frist Clinical Medicial College of Qingdao University

Qingdao, Shandong, 266555, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HRS-3095 Tablet

Drug

Oral HRS-3095 tablet.

HRS-3095 Placebo Tablet

Drug

Oral HRS-3095 placebo tablet.

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to 21 days.

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to 21 days.

Secondary outcomes

  1. Maximum concentration (Cmax)

    Time frame: Up to 17 days.

  2. Time of maximum concentration (Tmax)

    Time frame: Up to 17 days.

  3. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last)

    Time frame: Up to 17 days.

  4. Area under the concentration-time curve from time zero to infinity (AUC0-inf)

    Time frame: Up to 17 days.

  5. Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau)

    Time frame: Up to 17 days.

  6. Elimination half-life (t1/2)

    Time frame: Up to 17 days.

  7. Apparent clearance (CL/F)

    Time frame: Up to 17 days.

  8. Apparent volume of distribution (Vz/F)

    Time frame: Up to 17 days.

Sponsors and collaborators

Lead sponsor

Chengdu Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 17, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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