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OpenTrials
Completed

NCT Number: NCT05699993

A Study of IBI351 in Healthy Subjects

This is an open-label, two-cycle clinical study to evaluate the drug interaction between itraconazole or dextromethorphan and IBI351 in healthy subjects. A total of two cohorts of 12 healthy male subjects were planned to be enrolled in each cohort.

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Key information

Conditions

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, 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 in the range of 19 ~ 26 kg/m2 (including both ends).
  • Physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), thyroid function, 12-lead electrocardiogram, chest CT, abdominal ultrasound (hepatobiliary, pancreatic, spleen and kidney), echocardiography (only applicable to Cohort 1 subjects) showed no abnormalities; or abnormal test results but judged as normal or clinically insignificant by the investigator.

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

Itraconazole

Drug

Itraconazole was administered orally

IBI351

Drug

IBI351 was administered orally

dextromethorphan

Drug

Dextromethorphan was administered orally

Primary outcomes

  1. maximum concentrations (Cmax ) for IBI351

    Time frame: approximately 10 days

  2. maximum concentrations (Cmax ) for dextromethorphan

    Time frame: approximately 10 days

  3. area under the curve from time 0 to infinity(AUC0-inf) for IBI351

    Time frame: approximately 10 days

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

    Time frame: approximately 10 days

Secondary outcomes

  1. time-to-maximum concentration (Tmax) for IBI351

    Time frame: approximately 10 days

  2. half-life (t1/2) for IBI351

    Time frame: approximately 10 days

  3. area under the curve from time 0 to time (AUC0-t) for IBI351

    Time frame: approximately 10 days

  4. apparent clearance (CL/F) for IBI351

    Time frame: approximately 10 days

  5. apparent volume of distribution(Vz/F) for IBI351

    Time frame: approximately 10 days

  6. time-to-maximum concentration (Tmax) for dextromethorphan

    Time frame: approximately 10 days

  7. half-life (t1/2) for dextromethorphan

    Time frame: approximately 10 days

  8. area under the curve from time 0 to time (AUC0-t) for dextromethorphan

    Time frame: approximately 10 days

  9. apparent clearance (CL/F) for dextromethorphan

    Time frame: approximately 10 days

  10. apparent volume of distribution(Vz/F) for dextromethorphan

    Time frame: approximately 10 days

  11. area under the curve for dextrorphan

    Time frame: approximately 10 days

  12. maximum concentrations (Cmax ) for dextrorphan

    Time frame: approximately 10 days

  13. number of participants with abnormal hematology tests

    Time frame: approximately 10 days

  14. number of participants with abnormal chemistry parameters

    Time frame: approximately 10 days

  15. number of participants with abnormal vital signs

    Time frame: approximately 10 days

  16. number of participants with abnormal physical examination findings

    Time frame: approximately 10 days

  17. number of participants with abnormal ECG readings

    Time frame: approximately 10 days

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

An Open-label, 2-cycle Clinical Study to Evaluate the Drug Interaction Between Itraconazole or Dextromethorphan and IBI351 in Healthy Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 26, 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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