A Study of [14C]IBI351 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: [14C] IBI351

• Registration Number: NCT05626179
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-23
• Study Start: 2023-02-18
• Primary Completion: 2023-03-30
• Study Completion: 2023-05-18
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-24
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C] IBI351	[14C] IBI351	Recommended dose of \[14C\] IBI351

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China