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OpenTrials
Completed

NCT Number: NCT07101965

Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RSS0343 Tablets in Healthy Subjects After Single and Multiple Oral Administration and the Effect of Food on the Pharmacokinetics of RSS0343

To evaluate the safety and tolerability of RSS0343 tablets in healthy subjects after single and multiple oral administration

Completed

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)

Shandong, Jinan, 250013, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age of 18-55 years old (inclusive), male or female;
  • Body mass index in the range of 19-28 kg/m2 (inclusive).

Exclusion criteria

  • The results of physical examination, vital signs, laboratory tests, chest imaging, abdominal B ultrasound and 12-lead electrocardiogram were abnormal.
  • Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive;
  • Suspected allergy to the study drug or any component of the study drug, or severe allergy to any drug, food, toxin or other exposure;
  • Current active, latent, or inadequately treated M. tuberculosis (i.e., tuberculosis [TB]) infection;
  • Investigator-assessed clinically significant infection (e.g., requiring hospitalization or parenteral antimicrobial therapy) within 1 month before screening; A history of more than one previous episode of herpes zoster, or disseminated herpes zoster (one episode); Any history of other infections that the investigator considered might have been aggravated by study participation.

Treatment and study plan

RSS0343 tablets ;placebo

Drug

RSS0343 tablets and placebo were given orally as a single dose

Primary outcomes

  1. adverse events

    Time frame: The observation lasted until the 61th day

Secondary outcomes

  1. Cmax

    Time frame: The observation lasted until the 33th day

  2. AUC0-t

    Time frame: The observation lasted until the 33th day

  3. AUC0-inf

    Time frame: The observation lasted until the 33th day

  4. Tmax

    Time frame: The observation lasted until the 33th day

  5. t1/2

    Time frame: The observation lasted until the 33th day

  6. CL/F

    Time frame: The observation lasted until the 33th day

  7. Vz/F

    Time frame: The observation lasted until the 33th day

  8. Ae,urine

    Time frame: The observation lasted until the 33th day

  9. fe,urine

    Time frame: The observation lasted until the 33th day

  10. Relative bioavailability of premeal and postmeal administration

    Time frame: The observation lasted until the 16th day

  11. Neutrophil elastase (NE) activity in peripheral blood after repeated oral administration of RSS0343

    Time frame: The observation lasted until the 61th day

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

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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