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Completed

NCT Number: NCT06514963

A Trial of HRS-9813 in Healthy Volunteers

The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-9813 in healthy volunteers.

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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

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF);
  • Male or female aged 18-55 (adult healthy volunteers);
  • Body mass index (BMI) between 19 and 26 kg/m2;
  • Normal Electrocardiogram (ECG);
  • Men and women of childbearing potential must agree to take effective contraceptive methods.

Exclusion criteria

  • Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, urinary stones, urinary tract infection, or intestinal disorder including irritable bowel syndrome;
  • History or presence of malignancy; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion;
  • Seated systolic blood pressure (SBP) of <90 mmHg or seated diastolic blood pressure (DBP) of <60 mmHg;
  • Patients with orthostatic hypotension;
  • Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.

Treatment and study plan

HRS-9813

Drug

Specified dose on specified days

Placebo

Drug

Specified dose on specified days

Primary outcomes

  1. Safety: incidence of adverse event (AE), serious adverse event (SAE)

    Time frame: 7 days (SAD), 14 days (MAD)

Secondary outcomes

  1. PK parameter of HRS-9813: Area under the concentration time curve (AUC)

    Time frame: Days 1-9

  2. PK parameter of HRS-9813: Maximum Plasma Concentration (Cmax)

    Time frame: Days 1-9

  3. PK parameter of HRS-9813: Time to maximum plasma concentration (Tmax)

    Time frame: Days 1-9

  4. PK parameter of HRS-9813: Half-life (t1/2)

    Time frame: Days 1-9

  5. PK parameter of HRS-9813: Apparent clearance (CL/F)

    Time frame: Days 1-9

  6. PK parameter of HRS-9813: Apparent volume of distribution (Vz/F)

    Time frame: Days 1-9

  7. PK parameter of HRS-9813: Accumulation ratio (Racc)

    Time frame: Days 1-9

  8. PK parameter of HRS-9813: Cumulative amount excreted (Ae) in the urine

    Time frame: Days 1-2

  9. PK parameter of HRS-9813: Fractional excretion (fe) in the urine

    Time frame: Days 1-2

  10. PK parameter of HRS-9813: Renal clearance (CLR)

    Time frame: Days 1-2

Sponsors and collaborators

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Food Effect on the Pharmacokinetics of HRS-9813 Tablets After Single and Multiple Ascending Oral Doses in Healthy Volunteers

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2024
Registry last updated
Jan 8, 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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