Clinical trial NCT05626179: A Study of [14C]IBI351 in Healthy Subjects
Official title: A Mass Balance Study of [14C]IBI351 in Healthy Male Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-23
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: cumulative recovery of total radioactivity in excreta (urine and feces)
timeFrame: approximately 30 days after first dose
measure: percentage of metabolite in total exposure AUC in plasma (% AUC)
timeFrame: approximately 30 days after first dose
measure: percentage of each metabolite in urine to administered dose (% of administered dose)
timeFrame: approximately 30 days after first dose
measure: Percentage of each metabolite in feces to administered dose (% of administered dose)
timeFrame: approximately 30 days after first dose
measure: total radioactivity ratio for whole blood/plasma
timeFrame: approximately 30 days after first dose
measure: maximum concentrations (Cmax ) for total plasma radioactivity
timeFrame: approximately 30 days after first dose
measure: time-to-maximum concentration (Tmax) for total plasma radioactivity
timeFrame: approximately 30 days after first dose
measure: half-life (t1/2) for total plasma radioactivity
timeFrame: approximately 30 days after first dose
measure: 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
timeFrame: approximately 30 days after first dose
measure: area under the curve from time 0 to infinity(AUC0-inf) for total plasma radioactivity
timeFrame: approximately 30 days after first dose
measure: apparent clearance (CL/F) for total plasma radioactivity
timeFrame: approximately 30 days after first dose
measure: apparent volume of distribution(Vz/F) for total plasma radioactivity
timeFrame: approximately 30 days after first dose
Secondary outcomes:
measure: maximum concentrations (Cmax ) for plasma
timeFrame: approximately 30 days after first dose
measure: time-to-maximum concentration (Tmax) for plasma
timeFrame: approximately 30 days after first dose
measure: area under the curve from time 0 to the last time point (AUC0-t) for plasma
timeFrame: approximately 30 days after first dose
measure: area under the curve from time 0 to infinity(AUC0-inf) for plasma
timeFrame: approximately 30 days after first dose
measure: apparent clearance (CL/F) for plasma
timeFrame: approximately 30 days after first dose
measure: apparent volume of distribution(Vz/F) for plasma
timeFrame: approximately 30 days after first dose
measure: adverse events
timeFrame: approximately 30 days after first dose
measure: abnormality in vital signs
timeFrame: approximately 30 days after first dose
measure: abnormality in ECG parameters
timeFrame: approximately 30 days after first dose
measure: abnormality in physical examination
timeFrame: approximately 30 days after first dose
measure: abnormality in hematology parameters
timeFrame: approximately 30 days after first dose
measure: abnormality in clinical chemistry parameters
timeFrame: approximately 30 days after first dose
measure: abnormality in routine urinalysis parameters
timeFrame: approximately 30 days after first dose
measure: abnormality in routine stool parameters
timeFrame: approximately 30 days after first dose
measure: abnormality in coagulation parameters
timeFrame: approximately 30 days after first dose
measure: abnormality in Troponin T (TnT)
timeFrame: approximately 30 days after first dose
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References: