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Completed

NCT Number: NCT05688124

A Study of IBI351 in Healthy Subjects

This is a randomized, open-label, two-cycle clinical study to evaluate the drug interaction, food effect and pharmacokinetics of IBI351 and esomeprazole in healthy subjects. A total of two cohorts were planned to be enrolled in each cohort. Cohort 1: This cohort investigated the effect of esomeprazole on the pharmacokinetics of IBI351 in healthy subjects. Cohort 2: This cohort investigated the effect of food on the pharmacokinetics of IBI351 in healthy subjects.

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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

the First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, 215006, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • voluntarily sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol.
  • healthy male subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
  • body weight is not less than 50 kg, and body mass index (BMI) is within the range of 19 ~ 26 kg/m2 (including cut-off value).

Exclusion criteria

  • have taken any products containing alcohol or have a positive alcohol breath test (≥ 20 mg/100 ml) within 24 hours before taking study medication.
  • hepatitis B surface antigen HBsAg positive.
  • hepatitis C virus antibody positive.
  • positive AIDS antigen/antibody or Treponema pallidum antibody

Treatment and study plan

IBI351

Drug

IBI351 is administered orally

Esomeprazole

Drug

Esomeprazole is administered orally

Primary outcomes

  1. maximum concentrations (Cmax ) for plasma

    Time frame: approximately 10 days after first dose

  2. area under the curve from time 0 to infinity(AUC0-inf) for plasma

    Time frame: approximately 10 days after first dose

  3. area under the curve from time 0 to the last time point (AUC0-t) for plasma

    Time frame: approximately 10 days after first dose

Secondary outcomes

  1. time-to-maximum concentration (Tmax) for total plasma

    Time frame: approximately 10 days after first dose

  2. half-life (t1/2) for total plasma

    Time frame: approximately 10 days after first dose

  3. apparent clearance (CL/F) for total plasma

    Time frame: approximately 10 days after first dose

  4. the time prior to the first measurable (non-zero) concentration （tlag）

    Time frame: approximately 10 days after first dose

  5. apparent volume of distribution(Vz/F) for total plasma

    Time frame: approximately 10 days after first dose

  6. adverse events

    Time frame: approximately 10 days after first dose

  7. number of participants with abnormal ECG readings

    Time frame: approximately 10 days after first dose

  8. number of participants with abnormal hematology test results

    Time frame: approximately 10 days after first dose

  9. number of participants with abnormal chemisty test results

    Time frame: approximately 10 days after first dose

  10. number of participants with abnormal vital signs

    Time frame: approximately 10 days after first dose

  11. number of participants with abnormal physical examination

    Time frame: approximately 10 days after first dose

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Randomized, Open-label, Two-cycle Clinical Study to Evaluate the Drug Interaction, Food Effect and Pharmacokinetics of IBI351 With Esomeprazole in Healthy Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 18, 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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