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Completed

NCT Number: NCT05893576

A Relative Bioavailability Study of HRS9531 in Healthy Subjects

The purpose of this study is to evaluate the relative bioavailability of the new formulation of HRS9531 injection between the original formulation of HRS9531 injection.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Central hospital affiliated to Shandong first mecical university

Jinan, Shandong, 250014, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
  • Age 18-45 years on the date of signing informed consent (inclusive);
  • Body weight ≥50 kg for male and 45 kg for female, body mass index (BMI) within the range of 19.0-26.0 kg/m2 (inclusive);
  • Subjects with good general health, no clinically significant abnormalities.

Exclusion criteria

  • With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study;
  • Had a severe trauma or major surgery within 6 months prior to screening, planned to undergo surgery during the trial period;
  • Participants in clinical trials of any drug or medical device in the 3 months prior to screening;
  • Blood donation history or blood loss ≥400 mL within 3 month or ≥200 mL within 1 month before screening, or received blood transfusion within 3 months;
  • Allergic constitution includes severe drug allergy or history of drug allergy;
  • Hepatitis B surface antigen (HBsAg), HIV antibody detection, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
  • Breast-feeding women;
  • The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.

Treatment and study plan

HRS9531

Drug

Receive a single dose of HRS9531 of original formulation.

Primary outcomes

  1. Area Under the Concentration versus time curve (AUC) of HRS953

    Time frame: Start of treatment up to Day 43

  2. Maximum Concentration (Cmax) of HRS9531

    Time frame: Start of Treatment up to Day 43

  3. Calculate the ratio of bioavailability between the new formulation and original formulation of HRS9531 according to the equation F (relative bioavailability) =AUCT·DR/AUCR·DT×100%

    Time frame: Start of Treatment up to Day 43

Secondary outcomes

  1. Time to maximum concentration (Tmax)

    Time frame: Start of Treatment up to Day 43

  2. Apparent terminal half-life (t1/2)

    Time frame: Start of Treatment up to Day 43

  3. Clearance (CL/F)

    Time frame: Start of Treatment up to Day 43

  4. Apparent volume of distribution (VzF)

    Time frame: Start of Treatment up to Day 43

  5. Incidence and severity of adverse events

    Time frame: Screening period up to Day 43

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Relative Bioavailability Study of Single-dose, Randomized, Open-label, Single-period, Parallel Design of HRS9531 Injection Using Different Manufacturing Processes in Healthy Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2023
Registry last updated
Oct 24, 2023

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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