A Study of [14C]IBI351 in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: [14C] IBI351

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital of Nanjing Medical University
      • Contact: Jun Zhao; Phone Number: 025-68136221; Email: junzhaoj@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: [14C] IBI351; Recommended dose of [14C] IBI351	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 urine to administered dose (% of administered dose)	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
half-life (t1/2) 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
area under the curve from time 0 to infinity(AUC0-inf) 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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2023
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): May 18, 2023

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 24, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CIBI351P002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No