A Study of [14C]IBI351 in Healthy Subjects

Overview

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.

Full Title of Study: “A Mass Balance Study of [14C]IBI351 in Healthy Male Chinese Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 22, 2023

Interventions

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

Arms, Groups and Cohorts

  • Other: [14C] IBI351
    • Recommended dose of [14C] IBI351

Clinical Trial Outcome Measures

Primary Measures

  • cumulative recovery of total radioactivity in excreta (urine and feces)
    • Time Frame: approximately 30 days after first dose
  • percentage of metabolite in total exposure AUC in plasma (% AUC)
    • Time Frame: approximately 30 days after first dose
  • percentage of each metabolite in urine to administered dose (% of administered dose)
    • Time Frame: approximately 30 days after first dose
  • Percentage of each metabolite in feces to administered dose (% of administered dose)
    • Time Frame: approximately 30 days after first dose
  • total radioactivity ratio for whole blood/plasma
    • Time Frame: approximately 30 days after first dose
  • maximum concentrations (Cmax ) for total plasma radioactivity
    • Time Frame: approximately 30 days after first dose
  • time-to-maximum concentration (Tmax) for total plasma radioactivity
    • Time Frame: approximately 30 days after first dose
  • half-life (t1/2) for total plasma radioactivity
    • Time Frame: approximately 30 days after first dose
  • 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
  • area under the curve from time 0 to infinity(AUC0-inf) for total plasma radioactivity
    • Time Frame: approximately 30 days after first dose
  • apparent clearance (CL/F) for total plasma radioactivity
    • Time Frame: approximately 30 days after first dose
  • apparent volume of distribution(Vz/F) for total plasma radioactivity
    • Time Frame: approximately 30 days after first dose

Secondary Measures

  • maximum concentrations (Cmax ) for plasma
    • Time Frame: approximately 30 days after first dose
  • time-to-maximum concentration (Tmax) for plasma
    • Time Frame: approximately 30 days after first dose
  • area under the curve from time 0 to the last time point (AUC0-t) for plasma
    • Time Frame: approximately 30 days after first dose
  • area under the curve from time 0 to infinity(AUC0-inf) for plasma
    • Time Frame: approximately 30 days after first dose
  • apparent clearance (CL/F) for plasma
    • Time Frame: approximately 30 days after first dose
  • apparent volume of distribution(Vz/F) for plasma
    • Time Frame: approximately 30 days after first dose
  • adverse events
    • Time Frame: approximately 30 days after first dose
  • abnormality in vital signs
    • Time Frame: approximately 30 days after first dose
  • abnormality in ECG parameters
    • Time Frame: approximately 30 days after first dose
  • abnormality in physical examination
    • Time Frame: approximately 30 days after first dose
  • abnormality in hematology parameters
    • Time Frame: approximately 30 days after first dose
  • abnormality in clinical chemistry parameters
    • Time Frame: approximately 30 days after first dose
  • abnormality in routine urinalysis parameters
    • Time Frame: approximately 30 days after first dose
  • abnormality in routine stool parameters
    • Time Frame: approximately 30 days after first dose
  • abnormality in coagulation parameters
    • Time Frame: approximately 30 days after first dose
  • abnormality in Troponin T (TnT)
    • Time Frame: approximately 30 days after first dose

Participating in This Clinical Trial

Inclusion Criteria: 1. Voluntarily sign the informed consent form before the trial, and fully understand the content, process and possible adverse reactions of the trial. 2. Healthy male subjects aged 18 to 45 years (including both ends) at the time of signing informed consent. 3. 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). 4. 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 1. allergic constitution; known hypersensitivity to any component of the test drug or its preparation. 2. have special requirements for diet and cannot abide by the unified diet; or lactose intolerance. 3. history of dysphagia or any gastrointestinal disease that affects drug absorption. 4. blood donation or massive blood loss (> 200 mL) within 3 months before screening, or blood transfusion within 1 month. 5. Have taken an investigational product or participated in any clinical trial within 3 months before taking the study drug.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Innovent Biologics (Suzhou) Co. Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Xiuzhi Yu, 0512-69566088, xiuzhi.yu@innoventbio.com

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