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Completed

NCT Number: NCT05626179

A Study of [14C]IBI351 in Healthy Subjects

This study is to evaluate the mass balance of single oral dose of [14C] IBI351 in healthy subjects. Six to eight healthy male subjects were planned to be enrolled. After passing the screening, subjects were admitted to hospital and received training on medication, urine and feces collection and other procedures to ensure that they could perform relevant operations according to the protocol and SOP requirements. On the evening before medication, the patient had standard meals, and fasted uniformly overnight. On D1, the suspension containing recommended dose of [14C] IBI351 was administered in the morning on an empty stomach. Subjects have standardized meal during the trial and blood, urine, and feces samples were collected and safety laboratory tests were performed as scheduled.

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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 Nanjing Medical University

Nanjing, Jiangsu, 210029, 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, and fully understand the content, process and possible adverse reactions of the trial.
  • 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).
  • Vital signs, physical examination, laboratory tests (including blood routine, urine routine, blood biochemistry, coagulation, etc.), chest radiography, 12-lead ECG and other results were unremarkable; or abnormal examination results but judged by the investigator as clinically insignificant.

Exclusion criteria

  • allergic constitution; known hypersensitivity to any component of the test drug or its preparation.
  • have special requirements for diet and cannot abide by the unified diet; or lactose intolerance.
  • history of dysphagia or any gastrointestinal disease that affects drug absorption.
  • blood donation or massive blood loss (> 200 mL) within 3 months before screening, or blood transfusion within 1 month.
  • Have taken an investigational product or participated in any clinical trial within 3 months before taking the study drug.

Treatment and study plan

[14C] IBI351

Drug

The oral formulation of [14C] IBI351 was formulated as a suspension for subjects to take orally in drinking water under fasting conditions

Primary outcomes

  1. cumulative recovery of total radioactivity in excreta (urine and feces)

    Time frame: approximately 30 days after first dose

  2. percentage of metabolite in total exposure AUC in plasma (% AUC)

    Time frame: approximately 30 days after first dose

  3. percentage of each metabolite in urine to administered dose (% of administered dose)

    Time frame: approximately 30 days after first dose

  4. Percentage of each metabolite in feces to administered dose (% of administered dose)

    Time frame: approximately 30 days after first dose

  5. total radioactivity ratio for whole blood/plasma

    Time frame: approximately 30 days after first dose

  6. maximum concentrations (Cmax ) for total plasma radioactivity

    Time frame: approximately 30 days after first dose

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

    Time frame: approximately 30 days after first dose

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

    Time frame: approximately 30 days after first dose

  9. area under the curve from time 0 to the last time point (AUC0-t) for total plasma radioactivityarea under the curve from time 0 to the last time point (AUC0-t) for total plasma radioactivity

    Time frame: approximately 30 days after first dose

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

    Time frame: approximately 30 days after first dose

  11. apparent clearance (CL/F) for total plasma radioactivity

    Time frame: approximately 30 days after first dose

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

    Time frame: approximately 30 days after first dose

Secondary outcomes

  1. maximum concentrations (Cmax ) for plasma

    Time frame: approximately 30 days after first dose

  2. time-to-maximum concentration (Tmax) for plasma

    Time frame: approximately 30 days after first dose

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

    Time frame: approximately 30 days after first dose

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

    Time frame: approximately 30 days after first dose

  5. apparent clearance (CL/F) for plasma

    Time frame: approximately 30 days after first dose

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

    Time frame: approximately 30 days after first dose

  7. adverse events

    Time frame: approximately 30 days after first dose

  8. abnormality in vital signs

    Time frame: approximately 30 days after first dose

  9. abnormality in ECG parameters

    Time frame: approximately 30 days after first dose

  10. abnormality in physical examination

    Time frame: approximately 30 days after first dose

  11. abnormality in hematology parameters

    Time frame: approximately 30 days after first dose

  12. abnormality in clinical chemistry parameters

    Time frame: approximately 30 days after first dose

  13. abnormality in routine urinalysis parameters

    Time frame: approximately 30 days after first dose

  14. abnormality in routine stool parameters

    Time frame: approximately 30 days after first dose

  15. abnormality in coagulation parameters

    Time frame: approximately 30 days after first dose

  16. abnormality in Troponin T (TnT)

    Time frame: approximately 30 days after first dose

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Mass Balance Study of [14C]IBI351 in Healthy Male Chinese Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 23, 2022
Registry last updated
Dec 27, 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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